Does Articaine/Septocaine cause Parasthesias?

[Fullosseousflap]

Articaine/Septocaine is the newest addition to the local anesthetic arsenal and was approved by the Food and Drug Administration in April 2000. It has been in use in Europe since 1976 and in Canada since 1983. Its approval in the US has been delayed by the FDA due to the presence of a preservative which the agency said was unnecessary in single use carpules and was a potential allergen. It was approved when the French company Septodent finally removed the preservative from American shipments.

Yet today controvery exists whether articiane/septocaine causes parasthesias in either inferior alveolar blocks and/or infiltrations of the mandible. Dental bulletin boards like Dental Town and the Internet Dental Forum have been filled with case reports of either transient or more permanet parasthesias.

Read what Dr. Stan Malamed has to say here.

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[Yah-E]

Funny you brought this up, at all my OMFS externships, all the residents always taught me to never give IAN block with Septocaine, only use in difficult to anesthetized infected area via local infiltration.

 

[sdog]

Articaine/Septocaine is the newest addition to the local anesthetic arsenal and was approved by the Food and Drug Administration in April 2000. It has been in use in Europe since 1976 and in Canada since 1983. Its approval in the US has been delayed by the FDA due to the presence of a preservative which the agency said was unnecessary in single use carpules and was a potential allergen. It was approved when the French company Septodent finally removed the preservative from American shipments.

Yet today controvery exists whether articiane/septocaine causes parasthesias in either inferior alveolar blocks and/or infiltrations of the mandible. Dental bulletin boards like Dental Town and the Internet Dental Forum have been filled with case reports of either transient or more permanet parasthesias.

Read what Dr. Stan Malamed has to say here.

I learned there was an unusually higher rate of parasthesia after IAN blocks when using septocaine, specifically- after already blocking the patient and not being able to gauge proximity to the IA nerve based on sensation.

 

[north2southOMFS]

I have heard of this ?myth?. I remember in dental school being taught that septicaine had this potential complication, but I have never seen this in the literature...although I've never really looked for it either. But in dental school we did take the insert info in a packet of septocaine carps and read through it. Nowhere (this was in 2003) in that packet anywhere did it mention anything about a side effect of possible paresthesias when giving IAN blocks.

Maybe it is just the lidocaine company perpetuating a rumor to decrease sales of septocaine......hmmmm............



Anyway we just use lidocaine, i havent used septocaine since dental school. We just tell em.....Mamm, your infected and there is no way to get the tooth totally numb, just grip the chair and here we go!!!

 

[Fullosseousflap]

I have heard of this ?myth?. I remember in dental school being taught that septicaine had this potential complication, but I have never seen this in the literature...although I've never really looked for it either. But in dental school we did take the insert info in a packet of septocaine carps and read through it. Nowhere (this was in 2003) in that packet anywhere did it mention anything about a side effect of possible paresthesias when giving IAN blocks.

Maybe it is just the lidocaine company perpetuating a rumor to decrease sales of septocaine......hmmmm............



Anyway we just use lidocaine, i havent used septocaine since dental school. We just tell em.....Mamm, your infected and there is no way to get the tooth totally numb, just grip the chair and here we go!!!

OWWWWWWWWWWWWWWWWWWWWWWWW!

 

[DcS]

Funny, I have a Clinical Pharm exam tomorrow, and as part of the exam material, we were taught that articaine is a good alternative because it is more water soluble (so diffuses more easily), and provides longer pulpal anesthesia.

 

[Fullosseousflap]

Funny, I have a Clinical Pharm exam tomorrow, and as part of the exam material, we were taught that articaine is a good alternative because it is more water soluble (so diffuses more easily), and provides longer pulpal anesthesia.

Articaine/Septocaine is a very good anesthetic.

Do you have any evidence or citations from your clinical pharm class that you can share?

 

[DcS]

Articaine/Septocaine is a very good anesthetic.

Do you have any evidence or citations from your clinical pharm class that you can share?

Unfortunately not, it was on 1 slide which gave the structure of it, and said the advantages of better diffusion and longer pulpal anesthesia. No citations listed.

 

[USC2003]

Risks of paraesthesia have to do with the percent concentration. Septocaine is 4%, similarly Prilocaine 4% has shown increased incidence of Paraesthesia when used to give a IAN block. No 4% solution should be used to give Blocks.

 

[Fullosseousflap]

Risks of paraesthesia have to do with the percent concentration. Septocaine is 4%, similarly Prilocaine 4% has shown increased incidence of Paraesthesia when used to give a IAN block. No 4% solution should be used to give Blocks.

Ok, how do you reconcile this with Dr. Malamed's comments.

Do you have any citations for this?

Or is this your anecdotal/case report experience?

 

[tx oms]

Risks of paraesthesia have to do with the percent concentration. Septocaine is 4%, similarly Prilocaine 4% has shown increased incidence of Paraesthesia when used to give a IAN block. No 4% solution should be used to give Blocks.

FullOsseousFlap, I'm not sure how much weight to put on your blog's quote of Malamed. For all you know I am Stan Malamed. Someone claiming to be Dr. Malamed in an internet forum is not too reliable in my opinion. Still, I agree with you that articaine is probably a good/safe anesthetic. I have no experience with it, however. I also agree that USC2003 needs to provide some evidence for such a broad statement. I am not sure that his opening statement is correct, much less the final statement.

N2SOMFS, your father omsres and I are able to numb patients easily with lidocaine, even in the face of infection. Perhaps we can teach you the same trick. Or, perhaps the pain your patients experience is due to the fracture in their mandible.

 

[Fullosseousflap]

FullOsseousFlap, I'm not sure how much weight to put on your blog's quote of Malamed. For all you know I am Stan Malamed. Someone claiming to be Dr. Malamed in an internet forum is not too reliable in my opinion. Still, I agree with you that articaine is probably a good/safe anesthetic. I have no experience with it, however. I also agree that USC2003 needs to provide some evidence for such a broad statement. I am not sure that his opening statement is correct, much less the final statement.

N2SOMFS, your father omsres and I are able to numb patients easily with lidocaine, even in the face of infection. Perhaps we can teach you the same trick. Or, perhaps the pain your patients experience is due to the fracture in their mandible.

Yes, I am pretty sure it is Stan. I was trained by him and I know his language patterns and ip address (LOL!).

In any case, there have been alot of anecdotal postings on both Dental Town and IDF about Septocaine.

I use Articaine/Septocaine for both infiltrations and blocks. It works fine but then again I never had problems with lidocaine either. I have even done PDL"s and AMSA palatal's with The Wand and lidocaine and never had a problem - nor a paresthesia on any patient with any local.

If anyone has some evidence regarding parasthesias though I would appreciate the information.

 

[NVDental]

Last week I attended a CE course presented by JOHN A. YAGIELA, DDS, Ph.D from UCLA, on Feb 10th, and he said that there is no definitive evidence that Articaine is associated with an increased complication of parasthesia. HE did say that increasing the concentration of anesthetic increases the risk of paraesthesia as USC2003 has indicated. Dr. Yagiela also stated ( which is similar to what Sdog posted) the anecdotal evidence of parasthesia after the use of articaine occurred after having already blocked the IA nerve with another anesthetic, and thus not being able to gauge proximity to the IA nerve based on sensation. The chance of injecting directly into a nerve increases. Dr Yagiela followed up by stating that he does use Articaine but obtains oral informed consent.

 

[Fullosseousflap]

Last week I attended a CE course presented by JOHN A. YAGIELA, DDS, Ph.D from UCLA, on Feb 10th, and he said that there is no definitive evidence that Articaine is associated with an increased complication of parasthesia. HE did say that increasing the concentration of anesthetic increases the risk of paraesthesia as USC2003 has indicated. Dr. Yagiela also stated ( which is similar to what Sdog posted) the anecdotal evidence of parasthesia after the use of articaine occurred after having already blocked the IA nerve with another anesthetic, and thus not being able to gauge proximity to the IA nerve based on sensation. The chance of injecting directly into a nerve increases. Dr Yagiela followed up by stating that he does use Articaine but obtains oral informed consent.

Informed consent if not written down = non-existent, right?

And how would this informed consent be any different?

Did Dr. Yagiela cite any evidence?

 

[NVDental]

You can still obtain informed consent orally, just as long as you indicate that it was obtained in the dental chart. Sure its not as iron clad as having the patient sign an informed consent form, but it can still be effective.

As far as the correlation of parasthesia with increased concentration of local anesthetic, Dr. Yagiela mentioned a lab study, where that tested nerve destruction and anesthetic concentration. That evidence was not based on any clinical trials as far as I know.

As far as parasthesia after the administration of articaine after the patient is already blocked with another anesthetic, Dr Yagiela really only offered a hypothesis of why parasthesia may have occured in the cases that he has investigated. He said that all of the cases of parasthesia involving articaine were conducted in this method.

 

[Fullosseousflap]

You can still obtain informed consent orally, just as long as you indicate that it was obtained in the dental chart. Sure its not as iron clad as having the patient sign an informed consent form, but it can still be effective.

As far as the correlation of parasthesia with increased concentration of local anesthetic, Dr. Yagiela mentioned a lab study, where that tested nerve destruction and anesthetic concentration. That evidence was not based on any clinical trials as far as I know.

As far as parasthesia after the administration of articaine after the patient is already blocked with another anesthetic, Dr Yagiela really only offered a hypothesis of why parasthesia may have occured in the cases that he has investigated. He said that all of the cases of parasthesia involving articaine were conducted in this method.

I suppose the question I would have - what would one say about Articaine/Septocaine in this special oral informed consent (whether it is written in the chart or not)? This is especially so since there do not appear to be an evidence-based studies to support any claim of parasthesias.

Since the same anecdotes appear over and over again on the dental communication sites it is amazing to me that no investigator has done a study.

Or is there one out there?

 

[NVDental]

I suppose the question I would have - what would one say about Articaine/Septocaine in this special oral informed consent (whether it is written in the chart or not)? This is especially so since there do not appear to be an evidence-based studies to support any claim of parasthesias.

Since the same anecdotes appear over and over again on the dental communication sites it is amazing to me that no investigator has done a study.

Or is there one out there?

I believe that there have been a couple of studies that have been conducted. Dr. Yagiela showed a graph that showed that there has been a slight increase in Canada in parasthesia cases since the early 1980's, which is when articaine was introduced. However there was no direct evidence that stated that articaine was responsible for this increase. It just probably fuels the speculation. Dr Yagiela also said that Dr. Malamed has researched this. According to Dr. Malamed's report, there is no evidence that articaine carries an increased risk for parasthesia. However Dr. Yagiela did say that the anasthesia expert at UOP, obtained, under the freedom of information act, the same data that Dr. Malamed used for his study, and the DR. from UOP did find a small correlation that linked articaine to an increased risk for parasthesia.

It made me wonder how two Drs could come up with different results utilizing the same data. I think that there definitley needs to be some more studies on this. However the risk of parasthesia is still small in either case, so it would be difficult to create a study to track such a rare occurrence.


In the end Dr. Yagiela stated that he still uses articaine and just explains to his patients that articaine may be more effective, but may also carry a slight increased risk for parasthesia.

 

[Fullosseousflap]

I suppose the question I would have - what would one say about Articaine/Septocaine in this special oral informed consent (whether it is written in the chart or not)? This is especially so since there do not appear to be an evidence-based studies to support any claim of parasthesias.

Since the same anecdotes appear over and over again on the dental communication sites it is amazing to me that no investigator has done a study.

Or is there one out there?

Found a study!

Click here.

And another interesting study on Lidocaine vs Articaine/Septocaine.

Click this link here.

 

[MTJ]

Some studies report that articane is associated with 5-fold increase in incidence of paresthesia compared to lidocaine (Haas DA, Lennon D: A 21 year retrospective study of reports of paresthesia following local anesthetic administration. Journal of Canadian Dental Association 61:319, 1995)

Another study ( Wynn RL, Bergman SA, Meiller TF : Paresthesia associated with local anesthetics: a perspective on articaine. General Dentistry 51:498, 2003)

Clinical Studies indicate that the effectiveness of articaine is statistically indistinguishable compared with other local anesthetic .
(Haas D, Harper D, Saso M, Young E: Comparison of articaine and prilocaine anesthesia by infiltration in maxillary and mandibular arches. Anesth Prog 37:230, 1990)

Sorry if i can't post the articles since i got those references from a handout i had been given in dental school .

 

[Fullosseousflap]

Some studies report that articane is associated with 5-fold increase in incidence of paresthesia compared to lidocaine (Haas DA, Lennon D: A 21 year retrospective study of reports of paresthesia following local anesthetic administration. Journal of Canadian Dental Association 61:319, 1995)

Another study ( Wynn RL, Bergman SA, Meiller TF : Paresthesia associated with local anesthetics: a perspective on articaine. General Dentistry 51:498, 2003)

Clinical Studies indicate that the effectiveness of articaine is statistically indistinguishable compared with other local anesthetic .
(Haas D, Harper D, Saso M, Young E: Comparison of articaine and prilocaine anesthesia by infiltration in maxillary and mandibular arches. Anesth Prog 37:230, 1990)

Sorry if i can't post the articles since i got those references from a handout i had been given in dental school .

Look at the dates of two of your referenced papers - 1990 and 1995. That is like ancient history in the pharmaceutical world! I don't mean to be derogatory - just pointing out these facts.

These next studies are more current and the Norwegian paper cites the Haas work.

Click here.

Click this link here.

Any other studies that are more recent?

Anyone in the middle of research or a paper?

 

[north2southOMFS]

Look at the dates of two of your referenced papers - 1990 and 1995. That is like ancient history in the pharmaceutical world! I don't mean to be derogatory - just pointing out these facts.

Its not ancient history if the studies were conducted properly and neither drug has changed its formulation since then. Its perfectly legit, why do the same studies over????

 

[USC2003]

Merits of an article are not based on the year they were published. Some of the most fundamental papers in the various fields of medicine and dentistry are from papers published years ago. A paper's merit should be based on how the study was conducted.

 

[Fullosseousflap]

Its not ancient history if the studies were conducted properly and neither drug has changed its formulation since then. Its perfectly legit, why do the same studies over????

Why do you do the same studies over?

Remember your scientific method in high school biology?

Ok, and then I will let you answer the question (and I am not trying to be a smartass!).

 

[Fullosseousflap]

Merits of an article are not based on the year they were published. Some of the most fundamental papers in the various fields of medicine and dentistry are from papers published years ago. A paper's merit should be based on how the study was conducted.

Yes, but dentistry and medicine do change.....remember the gold foil? And the USC Gold Foil and Rubber Dam Atlas?

Well done stuff! But, does it apply today?

Uh....NO!

 

[tx oms]

Why do you do the same studies over?

Remember your scientific method in high school biology?

Ok, and then I will let you answer the question (and I am not trying to be a smartass!).

Fine, you're not trying to be a smartass, but must you regulate all posts on this website? Everytime I turn around there's another one of your posts challenging someone. The validity of a paper is not based on date of publication and the validity of a post is not based on Fullosseousflap's acceptance. Damn, it's like my 56 year old dad is surfing the web...

I like calling people out, but damn man, half the posts in this thread are yours! You call people out all the time. Worse yet, it's not in a sarcastic/funny way but in an extrememly condescending way, like you're talking to four years olds. I'm sure N2SOMFS remember his high school biology, probably better than you as he was in high school more recently! Do you remember the old condescending dental school prof we all hated? Don't be that guy.

 

[Fullosseousflap]

Fine, you're not trying to be a smartass, but must you regulate all posts on this website? Everytime I turn around there's another one of your posts challenging someone. The validity of a paper is not based on date of publication and the validity of a post is not based on Fullosseousflap's acceptance. Damn, it's like my 56 year old dad is surfing the web...

I like calling people out, but damn man, half the posts in this thread are yours! You call people out all the time. Worse yet, it's not in a sarcastic/funny way but in an extrememly condescending way, like you're talking to four years olds. I'm sure N2SOMFS remember his high school biology, probably better than you as he was in high school more recently! Do you remember the old condescending dental school prof we all hated? Don't be that guy.

Alright.... you have a point!

I will try not to be condescending and be more helpful.

 

[USC2003]

After reading Malamed's article I had a few questions. No where in the article was the site of injection mentioned. Please correct me if I am wrong, but Malamed never discussed the actual sites that the local anesthetic was administed (Inf. Alveolar N. block, infiltration, PSA, ASA). If this is correct, then his paper really does no credit in supporting the incidence of paraethesia with articaine for Inf. Alveolar N. blocks. In the paper he also notes that when looking at drug related adverse effects, the number 1 adverse effect of articaine was paraesthesia, while paraesthesia was the third most common drug related complication with lidocaine. He also states in his paper that he tried to counter the Lennon, Haas article by calling patients over the phone for follow-up of paraesthesia but I could not find the exact numbers of how many people he acutally followed up in each group. He mentioned that there was a 1% correlation in each group but out of 882 patients in the articaine group how many did he acutally have follow-up on? There is an artice by Eeden and Patel in the Br J OMFS 2002 Dec; 40(6): 519-20 which does specifically look at prolonged paraesthesia while using articaine for IAN blocks.
I believe that overall the incidence of paraesthesia while giving IAN blocks is relatively small even with the use of articaine. I myself don't use articaine for IAN blocks for the mere reason that I do believe there is a higher incidence of paraethesia, and I can provide just as good an anesthetic with lidociane and marcaine for IAN blocks.
If I did miss the above mentioned facts in Malamed's article please correct me.

Fullosseousflap,
My point to you in my earlier comment was merely that discrediting an article by the date it was published, as you did in your comment holds no weight.

 

[Fullosseousflap]

Well, we will agree to disagree on the date of studies and their effect on credibility especially with regard to pharmaceuticals and the molecular biology contained therein.

Old studies are that - OLD!

Science changes and methodology to measure the science changes.

You cannot evaluate a paper without recognizing this among many factors.

 

[Fullosseousflap]

After reading Malamed's article I had a few questions. No where in the article was the site of injection mentioned. Please correct me if I am wrong, but Malamed never discussed the actual sites that the local anesthetic was administed (Inf. Alveolar N. block, infiltration, PSA, ASA). If this is correct, then his paper really does no credit in supporting the incidence of paraethesia with articaine for Inf. Alveolar N. blocks. In the paper he also notes that when looking at drug related adverse effects, the number 1 adverse effect of articaine was paraesthesia, while paraesthesia was the third most common drug related complication with lidocaine. He also states in his paper that he tried to counter the Lennon, Haas article by calling patients over the phone for follow-up of paraesthesia but I could not find the exact numbers of how many people he acutally followed up in each group. He mentioned that there was a 1% correlation in each group but out of 882 patients in the articaine group how many did he acutally have follow-up on? There is an artice by Eeden and Patel in the Br J OMFS 2002 Dec; 40(6): 519-20 which does specifically look at prolonged paraesthesia while using articaine for IAN blocks.
I believe that overall the incidence of paraesthesia while giving IAN blocks is relatively small even with the use of articaine. I myself don't use articaine for IAN blocks for the mere reason that I do believe there is a higher incidence of paraethesia, and I can provide just as good an anesthetic with lidociane and marcaine for IAN blocks.
If I did miss the above mentioned facts in Malamed's article please correct me.

Fullosseousflap,
My point to you in my earlier comment was merely that discrediting an article by the date it was published, as you did in your comment holds no weight.

You should e-mail Dr. Malamed and ask him.

His e-mail address is on the USC site.

He was a good Professor wasn't he?

 

[dental8888]

EVERYONE here should go read some of the thousands of recent posts from actual injured people from Articaine in dental nerve block injections. The overwhelming majority of these people were injured from Articaine/Septocaine and not Lidocaine, and thus they are heavily debating the topic on this site. Many people are starting lawsuits against their dentists across the country. There are also links about a pending class action lawsuit against the manufacturer of Articaine.

www.sciential.net/cgi-bin/dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID1

Some people state they are PERMANENTLY BLIND, despite that this is only supposed to be temporary and never permanent.
The majority have the following symptoms from Articaine:
(1) chronic numbness and/or severe pain (and many are discussing SUICIDE because the pain is so severe for years) (one person did commit suicide last year before his trial date)
(2) ear problems
(3) heart problems
(4) stiff neck
-etc.
I believe these injuries from Articaine/Septocaine are vastly under-reported, and they appear to be increasing significantly as the use of Articaine has increased since the FDA gave approval. Many of the people stated that they are furious that their dentist did not tell them they were not getting the standard Lidocaine and did not tell them about any risks. Many also posted that their dentists not only did not report their injuries, but they denied their injuries completely. Therefore, many people on the site are trying to get everyone else to report their symptoms to the FDA themselves since their dentists won't do it. Several of the posts debating this topic give a citation reference to a well respected and published Journal article from the UK that clearly shows that dentists reported a dramatic rise in the injury rates when they started using Articaine in nerve blocks.
Please also ask your professors to read this website about all these new Articaine injuries that are going unreported to the FDA.

David

 

[sdog]

EVERYONE here should go read some of the thousands of recent posts from actual injured people from Articaine in dental nerve block injections. The overwhelming majority of these people were injured from Articaine/Septocaine and not Lidocaine, and thus they are heavily debating the topic on this site. Many people are starting lawsuits against their dentists across the country. There are also links about a pending class action lawsuit against the manufacturer of Articaine.

www.sciential.net/cgi-bin/dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID1

Some people state they are PERMANENTLY BLIND, despite that this is only supposed to be temporary and never permanent.
The majority have the following symptoms from Articaine:
(1) chronic numbness and/or severe pain (and many are discussing SUICIDE because the pain is so severe for years) (one person did commit suicide last year before his trial date)
(2) ear problems
(3) heart problems
(4) stiff neck
-etc.
I believe these injuries from Articaine/Septocaine are vastly under-reported, and they appear to be increasing significantly as the use of Articaine has increased since the FDA gave approval. Many of the people stated that they are furious that their dentist did not tell them they were not getting the standard Lidocaine and did not tell them about any risks. Many also posted that their dentists not only did not report their injuries, but they denied their injuries completely. Therefore, many people on the site are trying to get everyone else to report their symptoms to the FDA themselves since their dentists won't do it. Several of the posts debating this topic give a citation reference to a well respected and published Journal article from the UK that clearly shows that dentists reported a dramatic rise in the injury rates when they started using Articaine in nerve blocks.
Please also ask your professors to read this website about all these new Articaine injuries that are going unreported to the FDA.

David

While we're at it, why don't we read about how everyone who took Vioxx had a heart attack! Face it- class action lawsuits, case reports of this person going blind and that person committing suicide- that has NO scientific merit and is quite the same as saying the guy down the street, who weighed 500 pounds, smoked his whole life and ate Mcdonalds every day, died from a heart attack after being on Vioxx for a week- and that it's Merck's fault for his death!!! CUT ME A BREAK!!!

 

[Fullosseousflap]

EVERYONE here should go read some of the thousands of recent posts from actual injured people from Articaine in dental nerve block injections. The overwhelming majority of these people were injured from Articaine/Septocaine and not Lidocaine, and thus they are heavily debating the topic on this site. Many people are starting lawsuits against their dentists across the country. There are also links about a pending class action lawsuit against the manufacturer of Articaine.

www.sciential.net/cgi-bin/dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID1

Some people state they are PERMANENTLY BLIND, despite that this is only supposed to be temporary and never permanent.
The majority have the following symptoms from Articaine:
(1) chronic numbness and/or severe pain (and many are discussing SUICIDE because the pain is so severe for years) (one person did commit suicide last year before his trial date)
(2) ear problems
(3) heart problems
(4) stiff neck
-etc.
I believe these injuries from Articaine/Septocaine are vastly under-reported, and they appear to be increasing significantly as the use of Articaine has increased since the FDA gave approval. Many of the people stated that they are furious that their dentist did not tell them they were not getting the standard Lidocaine and did not tell them about any risks. Many also posted that their dentists not only did not report their injuries, but they denied their injuries completely. Therefore, many people on the site are trying to get everyone else to report their symptoms to the FDA themselves since their dentists won't do it. Several of the posts debating this topic give a citation reference to a well respected and published Journal article from the UK that clearly shows that dentists reported a dramatic rise in the injury rates when they started using Articaine in nerve blocks.
Please also ask your professors to read this website about all these new Articaine injuries that are going unreported to the FDA.

David

In your post you say, "Several of the posts debating this topic give a citation reference to a well respected and published Journal article from the UK that clearly shows that dentists reported a dramatic rise in the injury rates when they started using Articaine in nerve blocks."

What is this citation?

 

[north2southOMFS]

EVERYONE here should go read some of the thousands of recent posts from actual injured people from Articaine in dental nerve block injections. The overwhelming majority of these people were injured from Articaine/Septocaine and not Lidocaine, and thus they are heavily debating the topic on this site. Many people are starting lawsuits against their dentists across the country. There are also links about a pending class action lawsuit against the manufacturer of Articaine.

www.sciential.net/cgi-bin/dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID1

David

Dude, that site is a perfect example of why people like yourself are dumb. It is a site where a couple of dentists who are used as expert witnesses for the plaintiff(also known as whoring yourself out to the lawyers), are spreading a bunch of false rumors about lingual nerve and IAN injury following lower mandibular blocks. Nowhere in the posts have i seen anything evidence based.

Oh, they had a threat about it there, but of course there was nothing there of substance. A couple of "oh this many out of this many had nerve injury......"type papers. Was it transient or permanent? What nerve was injured? Just a bunch of "i think i read somewhere that there was a 22% chance of injury....." Think you read!!!....show me the money bitch!

Oh and they teach you how to sue for it there as well.

When a bunch of laypersons and lawyers get together and start posting bull**** on the internet it is very dangerous to our profession.

I have never done a lit search or review on this, so there may be studies out there that do show correlation, I hope someone will post them, but to go out and say it causes permanent blindness is just ridiculous. And do say "the majority have these....." what majority?.....where? are you talking about the majority on the internet site.....I can find you 50 internet sites that sell a product that makes your johnson 2 feet long...you believe that also?

We good clinicians try to practice evidence based medicine, not "my friend down the street said"....based medicine. Now lawyers like to rely on that goofy anecdotal based medicine.

 

[Fullosseousflap]

In your post you say, "Several of the posts debating this topic give a citation reference to a well respected and published Journal article from the UK that clearly shows that dentists reported a dramatic rise in the injury rates when they started using Articaine in nerve blocks."

What is this citation?

No response?

 

[dental8888]

(1) UK article links (many published studies by Dr. Pedlar, and published study by Dr. Eeden, in the British Journal of Oral Maxillofacial Surg.)
Pedlar J.
Re: Prolonged paraesthesia following inferior alveolar nerve block using articaine.
Br J Oral Maxillofac Surg. 2003 Jun;41(3):202.
PMID: 12804554
http://www.ncbi.nlm.nih.gov/entrez/...ve&db=pubmed&dopt=Abstract&list_uids=12907960

http://www.ncbi.nlm.nih.gov/entrez/...ve&db=pubmed&dopt=Abstract&list_uids=12464215

Dr. Pedlar in a published letter to the Journal of Oral & Maxillofacial Surgery wrote:
"Prolonged paraesthesia"

"Sir,- I read with interest recently a letter to the editor of the Journal of Oral & Maxillofacial Surgery1 on the apparent relationship between inferior alveolar nerve block injections with articaine and an apparently increased incidence of prolonged dysaesthesia. At the Leeds Dental Institute we too have observed an apparent increase in the incidence of prolonged dysaesthesia following inferior alveolar nerve block injection in the last few years (917 cases), all but one of which have been associated with articaine administration.

Your readers may wish to refer to a paper by D A Haas and D Lennon2 which showed a dramatic rise in reported incidents of dysaesthesia following local anaesthetic administration in Ontario, coincident with the introduction of articaine to dental practice in that province.

It would seem that there is sufficient evidence to urge some caution in the widespread use of articaine as a local anaesthetic alternative to lignocaine. A widespread survey of the relationship of prolonged dysaesthesia to particular drug choices would seem justified to clarify this apparent adverse effect."

J. Pedlar
Leeds"


Pedlar J.
Re: Prolonged paraesthesia following inferior alveolar nerve block using articaine.
Br J Oral Maxillofac Surg. 2003 Jun;41(3):202.
PMID: 12804554

Wynn RL, Bergman SA, Meiller TF.
Paresthesia associated with local anesthetics: a perspective on articaine.
Gen Dent. 2003 Nov-Dec;51(6):498-501. No abstract available.
PMID: 15055644

Meechan JG.
Br J Oral Maxillofac Surg. 2003
Re: Prolonged paraesthesia following inferior alveolar nerve block using articaine.

Penarrocha-Diago M, Sanchis-Bielsa JM.
Ophthalmologic complications after intraoral local anesthesia with
articaine.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jul;90(1):21-
Review.
PMID: 10884631; UI: 20345238

Also, a search using the URL below
http://www.ncbi.nlm.nih.gov/PubMed
can bring up many similar articles.

(2) Dower wrote that “the calculated data is provided in Table 5.
By this analysis there is a twenty times greater likelihood of paresthesia resulting from a mandibular block injection with articaine as compared to lidocaine. Prilocaine is calculated to have a fifteen times higher rate of mandibular paresthesia than lidocaine”.

By James S. Dower, Jr., DDS, MA

http://64.233.167.104/search?q=cach...p?d=40&parent=41+Articaine+lingual+numb&hl=en

(3) Haas and Lennon showed a dramatic rise in reported incidents of dysaesthesia following local anaesthetic administration in Ontario (cited in Pedlar’s letter and Dower’s reports)

Haas DA, Lennon D. A 21 year retrospective study of reports of paresthesia following local anesthetic administration. J Can Dent Assoc 1995;61(4):319-330.

(4) Exact quote: “Articaine and prilocaine are more likely than other anaesthetics to be associated with paraesthesia”
LOCAL ANAESTHETICS

Daniel A. Haas, BSc, D.D.S., BScD, PhD, FRCD(C)
(a) http://www.septodont.ca/Septodont/english/other/cea_dh01.html

(b) Haas DA. Localized complications from local anaesthesia. Journal of the California Dental Association 1998 26:677-81.

 

[north2southOMFS]

Ok , I'm glad to see you spent your weekend learning. This is good, it is actual scientific data. Except, did you actually read some of these or just put the topic in pubmed and spit out what came onto the screen. I can't get the british journal of OMFS online and frankly i just don't care enough to look it up in the library. But of the ones i can get, they aren't even saying its bad, just has a (slightly- higher) risk than lidocaine.(depending on who you read) And some of the articles are pointless....

Penarrocha-Diago M, Sanchis-Bielsa JM.
Ophthalmologic complications after intraoral local anesthesia with
articaine.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jul;90(1):21-
Review.
PMID: 10884631; UI: 20345238.

"The most commonly encountered symptoms were diplopia, mydriasis, palpebral ptosis, and abduction difficulties of the affected eye. In all cases, these effects occurred a few minutes after injection of the anesthetic, followed by complete resolution without sequelae on cessation of the anesthetic effect."
So what does that mean, the anesthetic works so good your infraorbial nerve block got into the extraocular muscles, but when it wore off everything was fine and dandy? where is the problem with that?

(2) Dower wrote that “the calculated data is provided in Table 5.
By this analysis there is a twenty times greater likelihood of paresthesia resulting from a mandibular block injection with articaine as compared to lidocaine. Prilocaine is calculated to have a fifteen times higher rate of mandibular paresthesia than lidocaine”. .

"Based on the Canadian study,4 the rate of paresthesia in Ontario for 1993 was estimated to be 1:785,000."

dude, that is almost one in a million, you have more of a chance of getting killed in a car accident on the way to the dentist office.

Dr. Pedlar in a published letter to the Journal of Oral & Maxillofacial Surgery wrote:
"Prolonged paraesthesia"

"Sir,- I read with interest recently a letter to the editor of the Journal of Oral & Maxillofacial Surgery1 on the apparent relationship between inferior alveolar nerve block injections with articaine and an apparently increased incidence of prolonged dysaesthesia. At the Leeds Dental Institute we too have observed an apparent increase in the incidence of prolonged dysaesthesia following inferior alveolar nerve block injection in the last few years (917 cases), all but one of which have been associated with articaine administration.

Your readers may wish to refer to a paper by D A Haas and D Lennon2 which showed a dramatic rise in reported incidents of dysaesthesia following local anaesthetic administration in Ontario, coincident with the introduction of articaine to dental practice in that province.

It would seem that there is sufficient evidence to urge some caution in the widespread use of articaine as a local anaesthetic alternative to lignocaine. A widespread survey of the relationship of prolonged dysaesthesia to particular drug choices would seem justified to clarify this apparent adverse effect."

J. Pedlar
Leeds".

That is a letter, not a scientific study.

(3) Haas and Lennon showed a dramatic rise in reported incidents of dysaesthesia following local anaesthetic administration in Ontario (cited in Pedlar’s letter and Dower’s reports)".

"From 1973 to 1993, there were 143 reports of paresthesia not associated with surgery."

143 divided by 20 years equals 7.15/year in all of canada. Again, what are the odds.

On top of that, articaine wansn't approved for use in canada until 1984, so how could this study possibly be accurate for the use of articaine and parasthesias if it started before it was even on the market?

"Further studies are needed to investigate the mechanisms for this, and to determine whether similar findings would be found elsewhere."

-straight out of the authors mouth.

You also conveniently forgot to post the others that popped up in the pubmed search.....


Malamed SF, Gagnon S, Leblanc D. Related Articles, Links
Articaine hydrochloride: a study of the safety of a new amide local anesthetic.
J Am Dent Assoc. 2001 Feb;132(2):177-85.
PMID: 11217590

"The overall incidence of adverse events in the combined studies was 22 percent for the articaine group and 20 percent for the lidocaine group."

"Articaine is a well-tolerated, safe and effective local anesthetic for use in clinical dentistry."

But then again its an american author so its probably dismissed....

I know the canadian and british journals are very good and they have valid points. In fact i will say you are right that articaine probably does have higher incidences of parethesias. i have no personal exp. b/c i don't use it. But to say it needs to come off the market because a web site posts people going blind, killing themselves, ear problems, heart problems (any LA could exacerbate heart disease b/c of the epi by the way), and "stiff necks, with no data to back it up is not very responsible in my opinion, but to each his own i guess...

 

[Fullosseousflap]

Ok , I'm glad to see you spent your weekend learning. This is good, it is actual scientific data. Except, did you actually read some of these or just put the topic in pubmed and spit out what came onto the screen. I can't get the british journal of OMFS online and frankly i just don't care enough to look it up in the library. But of the ones i can get, they aren't even saying its bad, just has a (slightly- higher) risk than lidocaine.(depending on who you read) And some of the articles are pointless....





"The most commonly encountered symptoms were diplopia, mydriasis, palpebral ptosis, and abduction difficulties of the affected eye. In all cases, these effects occurred a few minutes after injection of the anesthetic, followed by complete resolution without sequelae on cessation of the anesthetic effect."
So what does that mean, the anesthetic works so good your infraorbial nerve block got into the extraocular muscles, but when it wore off everything was fine and dandy? where is the problem with that?





"Based on the Canadian study,4 the rate of paresthesia in Ontario for 1993 was estimated to be 1:785,000."

dude, that is almost one in a million, you have more of a chance of getting killed in a car accident on the way to the dentist office.




That is a letter, not a scientific study.




"From 1973 to 1993, there were 143 reports of paresthesia not associated with surgery."

143 divided by 20 years equals 7.15/year in all of canada. Again, what are the odds.

On top of that, articaine wansn't approved for use in canada until 1984, so how could this study possibly be accurate for the use of articaine and parasthesias if it started before it was even on the market?

"Further studies are needed to investigate the mechanisms for this, and to determine whether similar findings would be found elsewhere."

-straight out of the authors mouth.

You also conveniently forgot to post the others that popped up in the pubmed search.....


Malamed SF, Gagnon S, Leblanc D. Related Articles, Links
Articaine hydrochloride: a study of the safety of a new amide local anesthetic.
J Am Dent Assoc. 2001 Feb;132(2):177-85.
PMID: 11217590

"The overall incidence of adverse events in the combined studies was 22 percent for the articaine group and 20 percent for the lidocaine group."

"Articaine is a well-tolerated, safe and effective local anesthetic for use in clinical dentistry."

But then again its an american author so its probably dismissed....

I know the canadian and british journals are very good and they have valid points. In fact i will say you are right that articaine probably does have higher incidences of parethesias. i have no personal exp. b/c i don't use it. But to say it needs to come off the market because a web site posts people going blind, killing themselves, ear problems, heart problems (any LA could exacerbate heart disease b/c of the epi by the way), and "stiff necks, with no data to back it up is not very responsible in my opinion, but to each his own i guess...

Great Post!

And how does dental8888 reconcile these abstracts with Dr. Stan Malamed's comments (February 2005) that are here?

 

[dental8888]

(1) Wow, has no one even dared to take out a calculator to see the real percentages with Malamed's stats? His own stats show that he found that Articaine resulted in a 2.67 times increased rate of Paraesthesia when compared to Lidocaine!!! That is more than double the rate of Paraesthesia injuries with Articaine. Therefore, he actually found the highest increase in Paraesthesia rates with Articaine than any of the other studies out there.
Malamed’s statistics are cited in full in Johansen’s published article:
www.odont.uio.no/studier/semesterboker/ Felles/prosjektoppgaver/H99/Johansen.pdf
Malamed found the following:
11 incidents of Paresthesia out of 882 injection with Articaine 4% versus
only 2 incidents of Paresthesia out of 443 with Lidocaine 2%. If you simply do the math you will get the numbers of .012 versus .0045, which equals a 2.67 times increased injury rate for Paraesthesia. Why has this not been exposed? I know someone here mentioned that one doctor found his data through the "freedom of information" act and wrote that it supported a slightly different conclusion, but true math shows it is a VASTLY different conclusion.
Malamed did the supportive study for Septodont, the manufacturer of Articaine, and is biased. (See the Septodont website that cites Malamed's study - http://www.septodontinc.com/caineinfo.php) It is ridiculous that Malamed concluded that the rates were just fine despite his own data.
You questioned if I really read the studies I posted. I read them, but the question here is did you really read them. Did anyone really read Malamed's study or merely blindly accept his incorrect conclusion of his own data?

(2) There are MANY studies that show that Articaine is not any more effective in pain relief than Lidocaine, and thus it is not worth the risk. Please ask me list more links to all of these many studies if you would like more references than just this one:
http://www.jendodon.com/pt/re/jendodontics/abstract.00004770-200408000-00002.htm;jsessionid=CnDSXBpyU3SSrBFnXywvzO9i3iqbmmTDi07GiJpnB2T2VkVVQgAT!872722892!-949856032!9001!-1
Anesthetic Efficacy of Articaine for Inferior Alveolar Nerve Blocks in Patients with Irreversible Pulpitis.
Journal of Endodontics. 30(8):568-571, August 2004.
Claffey, Elizabeth DDS, MS; Reader, Al DDS, MS; Nusstein, John DDS, MS; Beck, Mike DDS, MA; Weaver, Joel DDS, PhD

(3) It is incorrect to so quickly dismiss the thousands of posts from people injured with Articaine, on the dental injection discussion board, since absolutely no one there has a biased motive of sellling any product (such as you claimed about false posts to grow your johnson)
(website: www.sciential.net/cgi-bin/
dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID1)

(4) You completely missed the point of Dower's report in that the study originally done in Canada did not compare apples to apples. Therefore, he took the same data and compared only Articaine in nerve blocks (instead of including infiltrations which don't hit the nerve as often). Then Dower found a 22% greater rate of paraesthesia with Articaine versus Lidocaine.

(5) Blindness Injuries
Here are some of the many published journal articles establishing the connection with blindness:
(a) De Keyzer K, Tassignon MJ. Related Articles, Links Abstract [Case report: acute unilateral loss of visual acuity after a visit to the dentist: an unusual complication after the use of an anesthetic combined with adrenaline]
Rev Belge Med Dent. 2004;59(1):30-3. French.
PMID: 15295937 [PubMed - indexed for MEDLINE]

Occurrence of acute and unilateral blindness after local anaesthesia combined with adrenaline, for the treatment of dental caries. The blindness was caused by vasospasm of the central retinal artery. The dentists should be warned about possible visual complaints after use of local anaesthesia, which should urge them to refer the patient to the ophtalmologist.

(b) Penarrocha-Diago M, Sanchis-Bielsa JM. Related Articles, Links
Abstract Ophthalmologic complications after intraoral local anesthesia with articaine.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jul;90(1):21-4. Review.
PMID: 10884631 [PubMed - indexed for MEDLINE]

A series of 14 cases of ophthalmologic complications after intraoral anesthesia of the posterior superior alveolar nerve is presented. The most commonly encountered symptoms were diplopia, mydriasis, palpebral ptosis, and abduction difficulties of the affected eye. In all cases, these effects occurred a few minutes after injection of the anesthetic, followed by complete resolution without sequelae on cessation of the anesthetic effect. The pathogenic mechanism underlying such ophthalmologic disorders is discussed in terms of a possible diffusion of the anesthetic solution toward the orbital region.

(c) Koumoura F, Papageorgiou G. Related Articles, Links Abstract Diplopia as a complication of local anesthesia: a case report.
Quintessence Int. 2001 Mar;32(3):232-4.
PMID: 12066663 [PubMed - indexed for MEDLINE]

Diplopia caused by local anesthesia at the superior posterior alveolar nerve for the removal of the maxillary third molar is a rare complication. The diplopia is due to facial palsy of the oculomotor muscles of the globe. This paper describes the case of a 22-year-old woman, in whom diplopia was observed after an overall uncomplicated removal of the semi-impacted third molar. Possible causes of the anesthetic effects are reported. The most accepted explanation is that the anesthetic diffuses on the abducent nerve in the cavernous sinus. The necessary actions that the dental surgeon must perform are reported.

 

[north2southOMFS]

(1) Wow, has no one even dared to take out a calculator to see the real percentages with Malamed's stats? His own stats show that he found that Articaine resulted in a 2.67 times increased rate of Paraesthesia when compared to Lidocaine!!! That is more than double the rate of Paraesthesia injuries with Articaine. Therefore, he actually found the highest increase in Paraesthesia rates with Articaine than any of the other studies out there.
11 incidents of Paresthesia out of 882 injection with Articaine 4% versus
only 2 incidents of Paresthesia out of 443 with Lidocaine 2%. If you simply do the math you will get the numbers of .012 versus .0045, which equals a 2.67 times increased injury rate for Paraesthesia. Why has this not been exposed? I know someone here mentioned that one doctor found his data through the "freedom of information" act and wrote that it supported a slightly different conclusion, but true math shows it is a VASTLY different conclusion.
It is ridiculous that Malamed concluded that the rates were just fine despite his own data.
You questioned if I really read the studies I posted. I read them, but the question here is did you really read them. Did anyone really read Malamed's study or merely blindly accept his incorrect conclusion of his own data?.

Your right, who was I to question a dude on the internet, I can't believe i acutually believed malamed, i mean, its not like he wrote an entire book on the subject or anything.

((2) There are MANY studies that show that Articaine is not any more effective in pain relief than Lidocaine, and thus it is not worth the risk.

Thats fine, so don't use it. You don't have to. I don't. Why are you so concerned about everyone else? Damnit, your like an articaine nazi.

(3) It is incorrect to so quickly dismiss the thousands of posts from people injured with Articaine, on the dental injection discussion board, since absolutely no one there has a biased motive of sellling any product (such as you claimed about false posts to grow your johnson)
(website: www.sciential.net/cgi-bin/
dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID1)

There is also no one there with an actual clue about dentistry. So they continue to spread the latest rumor about what they saw in there most recent homeopathic journal.

(4) You completely missed the point of Dower's report in that the study originally done in Canada did not compare apples to apples. Therefore, he took the same data and compared only Articaine in nerve blocks (instead of including infiltrations which don't hit the nerve as often). Then Dower found a 22% greater rate of paraesthesia with Articaine versus Lidocaine.)

Huh?

(5) Blindness Injuries
Here are some of the many published journal articles establishing the connection with blindness:
(a) De Keyzer K, Tassignon MJ. Related Articles, Links Abstract [Case report: acute unilateral loss of visual acuity after a visit to the dentist: an unusual complication after the use of an anesthetic combined with adrenaline]
Rev Belge Med Dent. 2004;59(1):30-3. French.
PMID: 15295937 [PubMed - indexed for MEDLINE]

Occurrence of acute and unilateral blindness after local anaesthesia combined with adrenaline, for the treatment of dental caries. The blindness was caused by vasospasm of the central retinal artery. The dentists should be warned about possible visual complaints after use of local anaesthesia, which should urge them to refer the patient to the ophtalmologist.)

That is a valid argument. A bolus of LA with epi on a maxillary infiltration if carelessly placed too high could easily (especially on an infraorbial nerve block) be dumped very close(or directly) into the soft tissue contents of the globe(fat, muscle, nerves and vessels). This could allow the anesthetic to diffuse to the opthalmic vessels and cause them to vasoconstrict. I can't believe it is the articaine responsible though, all LA (except cocaine) are vasodilators remember, its the epi that constricts......and lidocaine has epi just like the others.

((b) Penarrocha-Diago M, Sanchis-Bielsa JM. Related Articles, Links
Abstract Ophthalmologic complications after intraoral local anesthesia with articaine.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jul;90(1):21-4. Review.
PMID: 10884631 [PubMed - indexed for MEDLINE]

A series of 14 cases of ophthalmologic complications after intraoral anesthesia of the posterior superior alveolar nerve is presented. The most commonly encountered symptoms were diplopia, mydriasis, palpebral ptosis, and abduction difficulties of the affected eye. In all cases, these effects occurred a few minutes after injection of the anesthetic, followed by complete resolution without sequelae on cessation of the anesthetic effect. The pathogenic mechanism underlying such ophthalmologic disorders is discussed in terms of a possible diffusion of the anesthetic solution toward the orbital region..

uh huh.


Come on. I don't have time to rebut all of these, your killin me here. What are you going to do next, put up a bunch of paresthesia induced suicide case reports? Or articaine induced heart disease case reports.

You really hate this stuff don't you.

I bet you don't approve of amalgam either. Or fluoride for that matter.

 

[dental8888]

Do you agree with me about Malamed's data? I don't understand why more people are not bringing to light all of his data, instead of just remembering his conclusions. (By the way, I don't have problems with amalgams or flouride). Also, the Septodont manufacturer itself admits all of those other complications I listed with ears, heart, neck, etc. on it's long list of adverse effects on their website or others. In addition, I would like to point out that most of the people posting on the "oral nerve injury board" with articaine injection injuries stated that they have been DIAGNOSED by neurologists as having chronic nerve injuries (many posts state they have been in severe pain and/or numb for over a year since the date of injury). I just believe the injuries are being unreported to the FDA now that it is on the market and not just a small test pool.

(1) Malamed got the approval for Aticaine from the FDA
Malamed was the one who did the Septodont (Septocaine/Articaine) study to push it through the FDA in the U.S (as seen on Septodont's own website). It was Malamed’s study that was submitted to the FDA with the same test pool of 882 injections of Articaine. Dower’s report cites that Septodont’s study submitted to the U.S. FDA reported 21 paresthesias in 882 patient treatments with articaine (it appears that Dower added in the injury rate for hypoesthesia). Dower also points out that if mandibular block injections were given in half of the appointments, the paresthesia rate would be:
1 paresthesia per 21 mandibular block injections.
Citation - http://www.nodentalpain.com/ArticaineParesthesia.html

(2) ALL the Studies show an Increase in Paresthesia rates with Articaine
Every single study has shown an increase in the the paresthesia rates for Articaine versus Lidocaine. The ONLY difference in the studies is over how big that difference is. It is becoming very clear after reading all of these studies, that some authors found big differences yet wrote it was not that bad, while some authors found smaller differences and wrote that it is a much more serious problem. What everyone here can at least conclude is that all these studies show an increase!!! An increase in the injury rates matters LEGALLY in terms of being sued, even if various authors want to argue over the size of the increase.

(3) Legal Consequences (not to mention moral implications)
Another of the many important reasons to use Lidocaine instead of Articaine is the that the manufacturer’s own website and product warning sheets identify paresthesia injury rates at over 1%. That legally requires obtaining informed consent from the patient for Articaine, whereas some studies have shown Lidocaine to have paresthesia rates under 1%, and thus informed consent will vary for Lidocaine among different states with different Supreme Court decisions on the issue. However, some states will still require consent because some are extremely protective of individual rights and allow the patient to make their own decisions for their bodies about risks. Some states have Supreme Court decisions that require a doctor to tell a patient about risks if they are inquisitive and are asking questions, even if it is not industry standard in that region to get informed consent.
www.law.arizona.edu/Journals/ALR/ALR2002/vol442/Morris_FINAL.pdf

 

[Fullosseousflap]

Do you agree with me about Malamed's data? I don't understand why more people are not bringing to light all of his data, instead of just remembering his conclusions. (By the way, I don't have problems with amalgams or flouride). Also, the Septodont manufacturer itself admits all of those other complications I listed with ears, heart, neck, etc. on it's long list of adverse effects on their website or others. In addition, I would like to point out that most of the people posting on the "oral nerve injury board" with articaine injection injuries stated that they have been DIAGNOSED by neurologists as having chronic nerve injuries (many posts state they have been in severe pain and/or numb for over a year since the date of injury). I just believe the injuries are being unreported to the FDA now that it is on the market and not just a small test pool.

(1) Malamed got the approval for Aticaine from the FDA
Malamed was the one who did the Septodont (Septocaine/Articaine) study to push it through the FDA in the U.S (as seen on Septodont's own website). It was Malamed’s study that was submitted to the FDA with the same test pool of 882 injections of Articaine. Dower’s report cites that Septodont’s study submitted to the U.S. FDA reported 21 paresthesias in 882 patient treatments with articaine (it appears that Dower added in the injury rate for hypoesthesia). Dower also points out that if mandibular block injections were given in half of the appointments, the paresthesia rate would be:
1 paresthesia per 21 mandibular block injections.
Citation - http://www.nodentalpain.com/ArticaineParesthesia.html

(2) ALL the Studies show an Increase in Paresthesia rates with Articaine
Every single study has shown an increase in the the paresthesia rates for Articaine versus Lidocaine. The ONLY difference in the studies is over how big that difference is. It is becoming very clear after reading all of these studies, that some authors found big differences yet wrote it was not that bad, while some authors found smaller differences and wrote that it is a much more serious problem. What everyone here can at least conclude is that all these studies show an increase!!! An increase in the injury rates matters LEGALLY in terms of being sued, even if various authors want to argue over the size of the increase.

(3) Legal Consequences (not to mention moral implications)
Another of the many important reasons to use Lidocaine instead of Articaine is the that the manufacturer’s own website and product warning sheets identify paresthesia injury rates at over 1%. That legally requires obtaining informed consent from the patient for Articaine, whereas some studies have shown Lidocaine to have paresthesia rates under 1%, and thus informed consent will vary for Lidocaine among different states with different Supreme Court decisions on the issue. However, some states will still require consent because some are extremely protective of individual rights and allow the patient to make their own decisions for their bodies about risks. Some states have Supreme Court decisions that require a doctor to tell a patient about risks if they are inquisitive and are asking questions, even if it is not industry standard in that region to get informed consent.
www.law.arizona.edu/Journals/ALR/ALR2002/vol442/Morris_FINAL.pdf

Thank you for your participation and the links.

Have you discussed this information with any investigators or had any communication with Dr. Malamed about his data?

Most clinical practitioners are not pharmacologists nor do we have the time to wait for five and ten year longitudinal studies.

However, Articaine has been in clinical use for many years in Europe and Canada. What are the evidence based findings? Or are the findings still subject to debate and argument? I could not access the referenced 2003 Dentistry Today article on their site. Can you access it and reprint it here?

 

[dental8888]

Dower's article is too long to post here. Please try this link for it:

www.dentistrytoday.com/ME2/default.asp
(Then just type the word "Dower" in the Search box and click enter. Please let me know if you still can't open this link.)

Dower, and other authors/studies which he cites, DID find a large increase in the injuries rates after Articaine was introduced in Canada. Dower wrote, "In viewing the pattern of dental injection-related paresthesia in Ontario, Canada from 1973 to 1993 (Figure 1), there is an abrupt change in frequency in 1985, the year after articaine was available in Canada." Dower also concludes that there is a 20 percent greater rate of paresthesia injuries with Articaine versus Lidocaine.

The truth is known by many authors, but it is being ignored. The question is why......
Dower points out that the FDA had the Canada study that showed a large increase but the FDA chose to ignore it (sounds familiar doesn't it). Maybe this will situation will change now that the FDA is changing.

Please visit this website where many people with paresthesias are posting and the majority are stating that they were injured by Articaine. There are new people posting constantly despite that this is supposed to be a "rare" injury. Perhaps the injury rates have increased in the U.S. dramatically just like in Canada after Articaine hit the market.
http://www.sciential.net/cgi-bin/dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID

 

[Fullosseousflap]

Dower's article is too long to post here. Please try this link for it:

www.dentistrytoday.com/ME2/default.asp
(Then just type the word "Dower" in the Search box and click enter. Please let me know if you still can't open this link.)

Dower, and other authors/studies which he cites, DID find a large increase in the injuries rates after Articaine was introduced in Canada. Dower wrote, "In viewing the pattern of dental injection-related paresthesia in Ontario, Canada from 1973 to 1993 (Figure 1), there is an abrupt change in frequency in 1985, the year after articaine was available in Canada." Dower also concludes that there is a 20 percent greater rate of paresthesia injuries with Articaine versus Lidocaine.

The truth is known by many authors, but it is being ignored. The question is why......
Dower points out that the FDA had the Canada study that showed a large increase but the FDA chose to ignore it (sounds familiar doesn't it). Maybe this will situation will change now that the FDA is changing.

Please visit this website where many people with paresthesias are posting and the majority are stating that they were injured by Articaine. There are new people posting constantly despite that this is supposed to be a "rare" injury. Perhaps the injury rates have increased in the U.S. dramatically just like in Canada after Articaine hit the market.
http://www.sciential.net/cgi-bin/dcforum/dcboard.cgi?az=list&forum=DCForumID1&conf=DCConfID

Ok, I have posted the entire Dentistry Today paper here.

The main questions/criticisms I have are:

1. Since the data is a quite a few years old, have there been any subsequent studies conducted? Especially, since the use of Articaine/Septocaine has increased in the USA over the last few years it would be important to see those numbers. Data from 1973-1993 is simply not as releveant as data from the past five years or ten years.

2. Have there been any subsequent papers or studies conducted? Have there been any studies/papers that attempt to reproduce or contradict this study.

3. The author, Dower, concluded with a number of questions. Why did he not answer them with follow-up studies if his data was not conclusive?

4. The clinical definition of parasthesia (be it transient or not) needs to be explored and further defined in any subsequent study.

5. Is the incidence of parasthesia clinically significant statistically? And is it being measured appropriately?

After reading this study and others, I believe the answers are still to be discovered.

 

[acudoc]

Hello All,

I am a person who suffers from a paresthesia/dysesthesia from a lower mandibular nerve block administered for a root canal procedure. This was done in July 07. I have a permanent lingual nerve injury from this procedure, and I must say it is an extremely debilitating and painful injury. Articaine (Septocaine) was used. Symptoms are burning pain, tingling, stiffness, and a "raw" feeling of the tongue, right side, with altered taste sensations also eminating form the right side of the tongue. This is constant 24/7. I have contacted Dr. Tony Progrel DDS., MD at UCSF to see if surgery is an option for my injury. According to him it is not. Surgery is not indicated for injectional injuries of the lingual nerve. He further stated that if there was no resolution after three months, the condition was most likely permanent. The reason I am posting here is to inform you that this injury is HORRIFIC, and that the risk is not worth it. You are literally playing russian roulette with peoples lives, and I can fully understand why some would contemplate suicide. I did, and I'm a very healthy, strong, and stable individual, but this injury brought me to tears almost daily for several months. Knowing I am going to be suffering like this for the rest of my life is nightmarish, and you MUST know how serious this is. Malamed is full of you know what... his own studies show there is a 22% increase in paresthesias when articaine is used for lower mandibular nerve blocks. That is TOTALLY unacceptable. You should also know that I recieved NO informed consent on this, oral or written. For those of you who scoff at the data, or the sciental site where desperate individuals are posting their experiences, you are way off base. Nothing, I repeat, NOTHING is worth taking a chance of injuring someone. I would rather die than get injured again. All of my dental work is now done without any anesthetic. I recently had another root canal done this way. When it was time to clean out the root, my dentist injected carbocaine directly into the root, which worked like a charm with no danger to my lingual or IAN nerve. I hope some of you will take that to heart.

 

[Streetwolf]

Well before this probably gets locked...

I have no idea what everyone above said because this post is > 3 years old and I'm not going to read it. But in our pain control class a few months ago we were taught that septocaine (articaine) is good to use anywhere except for an IAN block where it *could* lead to paresthesia/dysesthesia (what you have). For this particular block the benefits do not outweigh the risks. Any other injection site would be fine using Septocaine.

Again this was said in class and I have not read any literature on this particular drug.

You say nothing is worth the chance of injuring someone. I disagree. A life is the most valuable thing and that's why we have the concept of risks vs benefits. Any injection (though probably not life threatening) carries a risk of nerve injury but the benefit of comfort and lack of pain far outweighs the risk of said injury, which will be low in incidence. I also would not recommend avoiding local anesthetics the rest of your life unless you can tolerate the pain. Like you said, carbocaine worked for you recently.

As for consent, if you signed ANY form for a procedure it probably had a line on it mentioning possible risks of getting local anesthetic.

 

[acudoc]

Streetwolfe,

I'm sorry to say you are completely off base and probably have little to no experience with this injury. Articaine should NEVER be used for lower mandibular blocks, PERIOD. If you bother to read the PACKAGE INSERT from Septodont, the maker of Septocaine, you will find that they also warn of persistent and permanent paresthesias from this procedure. Years ago novacain (procaine) was used and it NEVER caused nerve injury. It isn't neurotoxic, that's why. Even lidocaine, which is toxic but no where nearly as toxic as articaine, has far, far fewer injuries to it's name for mandibular blocks. Please read Dentistry Today's review of Malamed's "study".... if articane is used for lower mandibular blocks, there is a 1 in 22 % chance of this injury. THIS IS OUTRAGEOUS! Furthermore, the injury is life threatening if one commits suicide, and believe me that is what this injury can do. It is simply inhuman to subject your patients to this kind of injury when safer drugs are available. The literature is clear, the incidence of paresthesias/dysesthesias are far, far greater when articane is used. There is no need for a 4% solution when 2% works just fine... and the thiol ring makes this stuff absolutely dangerous because it penetrates any tissue, even bone thus exposing the lingual nerve or IAN to severe and permanent damage. I am now forced to undergo all my dental procedures without an anesthetic because of my permanent and debilitating injury. Perhaps if you experienced a tongue that felt like a blow torch was attached to it 24/7 with horrific taste sensations on top of it, you might think twice. In addition, there is no therapy that can alleviate the symptoms, including surgery. You know little of what you speak. Like I said, playing russian roulette with your patients lives is completely unacceptable, especially when SAFER ALTERNATIVES exist.

 

[acudoc]

streetwolfe,

I forgot to mention that I did not sign any informed consent, nor was I informed orally of the potential risk from the procedure. In fact, I questioned the need for the injection at all because I rarely use anesthetic for dental work, including fillings. This dentist insisted it was necessary.

 

[aphistis]

Streetwolfe,

I'm sorry to say you are completely off base and probably have little to no experience with this injury. Articaine should NEVER be used for lower mandibular blocks, PERIOD. If you bother to read the PACKAGE INSERT from Septodont, the maker of Septocaine, you will find that they also warn of persistent and permanent paresthesias from this procedure. Years ago novacain (procaine) was used and it NEVER caused nerve injury. It isn't neurotoxic, that's why. Even lidocaine, which is toxic but no where nearly as toxic as articaine, has far, far fewer injuries to it's name for mandibular blocks. Please read Dentistry Today's review of Malamed's "study".... if articane is used for lower mandibular blocks, there is a 1 in 22 % chance of this injury. THIS IS OUTRAGEOUS! Furthermore, the injury is life threatening if one commits suicide, and believe me that is what this injury can do. It is simply inhuman to subject your patients to this kind of injury when safer drugs are available. The literature is clear, the incidence of paresthesias/dysesthesias are far, far greater when articane is used. There is no need for a 4% solution when 2% works just fine... and the thiol ring makes this stuff absolutely dangerous because it penetrates any tissue, even bone thus exposing the lingual nerve or IAN to severe and permanent damage. I am now forced to undergo all my dental procedures without an anesthetic because of my permanent and debilitating injury. Perhaps if you experienced a tongue that felt like a blow torch was attached to it 24/7 with horrific taste sensations on top of it, you might think twice. In addition, there is no therapy that can alleviate the symptoms, including surgery. You know little of what you speak. Like I said, playing russian roulette with your patients lives is completely unacceptable, especially when SAFER ALTERNATIVES exist.

1) Articaine is an excellent local anesthetic and I am glad to have it in my armamentarium. I use it most frequently for local infiltration of mandibular teeth that are refractory to nerve block, but have used it on numerous occasions to place mandibular or inferior alveolar nerve blocks when I did not have lidocaine immediately available. I do not apologize for this.

2) While I sympathize with your condition (and I mean that sincerely), your claim that either 4% or 22% (I can't tell which you mean) of patients receiving articaine experience permanent nerve damage is patently ridiculous, and merits neither consideration nor rebuttal.

3) Procaine is an ester local anesthetic whose metabolites include para-aminobenzoic acid, a highly allergenic compound responsible for allergic reactions in a significant number of patients. Furthermore, its slow, unpredictable onset and short, unpredictable duration make it an extremely suboptimal agent.

4) Your reluctance to undergo local anesthesia after your injury is understandable, but nobody is forcing you to do anything.

5) Nobody is playing Russian roulette with anything, and your insistence on overstating the risks of local anesthesia isn't helping your argument.

As a licensed dentist, I can assure you I know a goodly amount about what I speak. I value patient autonomy very highly and would never impose my wishes on an unwilling patient; nonetheless, if someone refuses to let me anesthetize them for a procedure known to be significantly painful, they will be given a listing of other dentists and be politely shown the door.

Again, I genuinely empathize with your plight and I wouldn't wish your situation on anyone, but local anesthesia is one of the landmark achievements of modern medicine, and articaine is a contributing ingredient to its success. Sequelae such as yours are truly unfortunate; however, they can occur with any drug, they are quite uncommon, and--most importantly--the cumulative benefit a drug like articaine offers our patients far exceeds the remote risks it poses.

 

[doc toothache]

www.ineedce.com

http://www.ineedce.com/courses/1585/PDF/Articaine.pdf

 

[Rajan247]

+1

1) articaine is an excellent local anesthetic and i am glad to have it in my armamentarium. I use it most frequently for local infiltration of mandibular teeth that are refractory to nerve block, but have used it on numerous occasions to place mandibular or inferior alveolar nerve blocks when i did not have lidocaine immediately available. I do not apologize for this

2) while i sympathize with your condition (and i mean that sincerely), your claim that either 4% or 22% (i can't tell which you mean) of patients receiving articaine experience permanent nerve damage is patently ridiculous, and merits neither consideration nor rebuttal.

3) procaine is an ester local anesthetic whose metabolites include para-aminobenzoic acid, a highly allergenic compound responsible for allergic reactions in a significant number of patients. Furthermore, its slow, unpredictable onset and short, unpredictable duration make it an extremely suboptimal agent.

4) your reluctance to undergo local anesthesia after your injury is understandable, but nobody is forcing you to do anything.

5) nobody is playing russian roulette with anything, and your insistence on overstating the risks of local anesthesia isn't helping your argument.

As a licensed dentist, i can assure you i know a goodly amount about what i speak. I value patient autonomy very highly and would never impose my wishes on an unwilling patient; nonetheless, if someone refuses to let me anesthetize them for a procedure known to be significantly painful, they will be given a listing of other dentists and be politely shown the door.

Again, i genuinely empathize with your plight and i wouldn't wish your situation on anyone, but local anesthesia is one of the landmark achievements of modern medicine, and articaine is a contributing ingredient to its success. Sequelae such as yours, are truly unfortunate; however, they can occur with any drug, they are quite uncommon, and--most importantly--the cumulative benefit a drug like articaine offers our patients far outweighs the risk it poses.