allergic reaction

[pharmacology888]

How can I tell whether it's an allergic reaction or simply a side effect of the drug? For example, I had a customer complain after taking levaquin he developed a rash on his skin (he is allergic to penicillin only and he is currently not taking any other drugs). Is this a true allergy (and therefore the medication should be stopped) or is this an ADR of the antibiotic (Levaquin can cause some skin itching)?

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[Old Timer]

In this case, you need to refer the patient to a health care professional who can diagnose the rash....

 

[RxWildcat]

+1

we don't diagnose

 

[pharmdinfl]

How can I tell whether it's an allergic reaction or simply a side effect of the drug? For example, I had a customer complain after taking levaquin he developed a rash on his skin (he is allergic to penicillin only and he is currently not taking any other drugs). Is this a true allergy (and therefore the medication should be stopped) or is this an ADR of the antibiotic (Levaquin can cause some skin itching)?

If you have access to Pharmacist's Letter, there is an excellent article that will help you better understand the nature of drug allergies. Just in case you do, it is in the Oct. 2007, Volume 23 article.

 

[BMBiology]

I agree you should tell the patient to inform his PCP of any allergic reaction but providing information regarding drug allergy is within the practice of pharmacy.

If it is just a rash, then it is not a true allergic reaction and the med does not need to be stopped. If it is true allergic reaction then there should be other signs such as difficulty breathing, swelling (usually occurs within 72 hours) and the med should be stopped. So ask about those signs.

I would also ask about his previous PCN allergy. Patients who are allergic to one abx is more likely to be allergic to another. Levaquin can also cause rash as a side effect so it is important to look for other signs to differentiate between an adverse reaction vs. allergic reaction.

 

[davidtfull]

Levaquin belongs to the fluoroquinolone class, and severe adverse reactions (rather than allergic reactions) involving the skin is associated with it's use. For example Factive is being reviewed for disfiguring rashes. Recently an European Dear Doctor Letter was issued for Avelox in regards to fatal reactions (SJS and TEN) as well as fatal liver damage. I would strongly suggest putting this patient on an antibiotic with a far safer safety profile than a fluoroquinolone drug, especially levaquin which has the worse safety profile of this whole class in my opinion.

Additionally the FDA, after twenty five years, FINALLY added black box warnings concerning spontaneous tendon ruptures. Any number of patients have complained of the rash you are describing escalating into severe skin damage. In most cases this is a phototoxic reaction rather than an allergic reaction, which has proven to be extremely difficult to treat, and the severity appears to be dosed dependent.

For further information regarding the safety profile of this drug, and this class in particular, please log unto www.fqresearch.org

The FDA is currently being sued to add additional black box warnings as well as issuing dear doctor letters concerning this class by Public Citizen. The Attorney General of the State of Illinois had filed a petition seeking these changes back in 2005, Public Citizen filed a petition in 2006, and the FDA basically ignored them. The Attorney General has stated that this latest action by the FDA is no where near sufficient and intends to continue to seek adequate warnings and additional black boxes.

More than half of the drugs found in this class have been removed from clinical practice due to fatal adverse reactions. And I believe that several more will be removed as well in the very near future. (avelox, factive and levaquin)

Under these circumstances, if at all possible, common sense would dictate that another drug be used and the patient be referrred to a specialist for treatment. I rather doubt that this is just an allergic reaction, but the onset of the severe and debilating adverse reactions one experiences with this class.

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
[email protected]
[email protected]

 

[BMBiology]

I rather doubt that this is just an allergic reaction, but the onset of the severe and debilating adverse reactions one experiences with this class.

You have not talked to the patient or examined the patient but yet, you are already assuming it is a severe skin reaction.

 

[slaitken]

I would strongly suggest putting this patient on an antibiotic with a far safer safety profile than a fluoroquinolone drug, especially levaquin which has the worse safety profile of this whole class in my opinion.

In most cases this is a phototoxic reaction rather than an allergic reaction, which has proven to be extremely difficult to treat, and the severity appears to be dosed dependent.

For further information regarding the safety profile of this drug, and this class in particular, please log unto www.fqresearch.org

And I believe that several more will be removed as well in the very near future. (avelox, factive and levaquin)

I rather doubt that this is just an allergic reaction, but the onset of the severe and debilating adverse reactions one experiences with this class.

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
[email protected]
[email protected]

What sort of qualifications do you have to make these ridiculous recommendations and assumptions? Do you have any research or hard data to back up these quantitative statements?

Wrong place to preach, Mr. Fuller.

 

[rxforlife2004]

How can I tell whether it's an allergic reaction or simply a side effect of the drug? For example, I had a customer complain after taking levaquin he developed a rash on his skin (he is allergic to penicillin only and he is currently not taking any other drugs). Is this a true allergy (and therefore the medication should be stopped) or is this an ADR of the antibiotic (Levaquin can cause some skin itching)?

True drug allergies occur when there is an allergic reaction to a medication. First time u take it, your body immune system will learn and launch an incorrect response to such drug and stores to memory. Second time, it would generate an immune response which produces antibodies and histamines. In this case, u see hives and rash. Some true allergies can cause SOB, resp failure, etc...anaphylaxis and/or even death. These are anaphylaxis signs/Sx (from medicineplus.net):
Difficulty breathing with wheeze or hoarse voice
Hives over different parts of the body
Fainting, light-headedness
Dizziness
Confusion
Rapid pulse
Sensation of feeling the heart beat (palpitations)
Nausea, vomiting
Diarrhea
Abdominal pain or cramping
When i work as a pharmacist, this is the first thing i do: check pt's allergy. No matter how busy you are, always check it 'cuz being lazy for a minute can put a patient to coma or even irreversible death. A lot of my fellow pharmacists tend to assume NKDA (No known drug allergy) when it's getting busy and hectic, and the nurses forget to write down in the chart. Big big mistake...

 

[davidtfull]

The question asked was: How can I tell whether it's an allergic reaction or simply a side effect of the drug? For example, I had a customer complain after taking levaquin he developed a rash on his skin (he is allergic to penicillin only and he is currently not taking any other drugs). Is this a true allergy (and therefore the medication should be stopped) or is this an ADR of the antibiotic (Levaquin can cause some skin itching)?

I apologize if anyone took offense to my comments. The question being asked was whether or not this was a true allergic reaction or if this was a possible adverse reaction to levaquin. My words of caution are based upon the fact that such a rash MAY be a precursor to a serious reaction that is associated with levaquin. Such reactions include Stevens–Johnson's Syndrome, Sweet's Syndrome, T.E.N, as well as painful and disfiguring rashes.

Two types of photosensitivity reactions have been associated with fluoroquinolone therapy: photoallergic reactions and phototoxic responses. Photoallergic reactions require previous exposure to a drug in the class. In contrast, phototoxic responses can develop without previous exposure to a fluoroquinolone. Some of the fluoroquinolones induce photosensitivity reactions, such as erythema of sun-exposed skin, with varying frequency.

Photosensitivity reactions are postulated to occur as a result of fluoroquinolone photodegradation, as well as the molecule's ability to generate free monovalent oxygen radicals. In turn, these oxidative radicals may attack cellular lipid membranes, initiating inflammatory processes, and eventually produce DNA damage. Evidence for photo-induced oxidative DNA damage is demonstrated by the development of murine tumors in mice treated with Lomefloxacin. Drug-induced purpura is due to direct capillary damage or hypersensitivity reactions. (Thus to be considered vascular in nature)

Photosensitivity reactions reported with the fluoroquinolones mimic those of sunburn, with erythema and edema in the milder forms, and painful blistering with subsequent peeling when severe. A wide spectrum of cutaneous ADRs are reported with fluoroquinolones such as:

Stevens–Johnsons Syndrome
Pemphigus Vulgaris
Sweet's Syndrome (an acute febrile neutrophilic dermatosis)
T.E.N, a life-threatening skin disorder in which the top layers of skin blister and peel off in sheets.

A previous dematologic adverse reaction to a fluoroquinolone can sensitize a patient to more severe adverse reactions (with onset after only a single dose of the subsequent fluoroquinolone) as noted
earlier. Patients who develop any kind of rash to a fluoroquinolone in the past have a potential to develop life threatening photoallergic reactions when re-challenged with a fluoroquinolone drug later on in life.

Photoexposed purpuric eruptions are another side effect of fluoroquinolone therapy in addition to photosensitivity rashes. Purpura is defined as circumscribed collection of blood 0.5 cm in diameter. Morphologically it may be of several types as ecchymoses, petechiae, palpable purpura, pigmented type, or itching purpura. (In
my case such a rash has persisted for over twenty years now)

It is to be noted that within the clinical studies submitted with the initial submission of another fluoroquinolone drug, a higher than expected rate of rash was noted in these clinical studies.
During the course of the NDA review significant questions arose regarding the safety of the fluoroquinolones in this regard.

These questions centered around the higher than expected rate of rash reported in patients receiving fluoroquinolones and related questions regarding the mechanism of the observed rash, the potential for cross- sensitization, and the possibility that the frequent occurrence of rash may portend a risk for more serious infrequent cutaneous drug reactions. The drug's sponsor never provided satisfactory answers to these concerns, in my opinion. In addition, there were also unresolved questions regarding the hepatic safety profile of this class. As we see with the recent Eurpean Dear Doctor Letter concerning Avelox as well as the ongoing investigation by Health Canada regarding levaquin.

The rates of rash ranged upwards to 25% depending upon the population or subset of the population being analyzed. Analyses of this rash data have shown that female gender, age (younger adults), and longer duration of therapy are associated with an increased rate of this rash. In spite of the additional risk of the patient developing TEN, Stevens-Johnson Syndrome as well as Sweet's Syndrome, the FDA approved the drug anyhow.

The public record of the FDA meeting in which these rashes were discussed revealed several occasions where the members of the panel literally laughed out loud at patients reporting such rashes and ridiculed them. Only to find, four years later, that the real-world use of this class has shown what clinical trials previously revealed and the FDA panel members laughed at: the risk of rashes associated with the fluoroquinolones, especially for women undergoing treatment with gemifloxacin.

In 2006 the FDA convened another panel to take yet another look at the safety profile of gemifloxacin.

It was not my intention to be "preaching" here, but rather providing documented and published information regarding the fact that such rashes are not to be dismissed lightly or thought to be simply an allergic reaction that would abate upon cessation of therapy when they are induced by the fluoroquinolone class. There is a substantial risk with levaquin that it would not be just an allergic reaction. And clearly stated as such within the package insert for this drug.

What the person who asked this question now does with this information is entirely up to them..

It was not my intention to cause any kind of discord on this board, but to provide relevant information by which a person would then be able to make the correct decision. Rather unkind of you to be taking cheap shots at the messenger because you may have some issues regarding the message being delivered.

You asked: What sort of qualifications do you have to make these ridiculous recommendations and assumptions?

I am baffled as to what you find to be ridiculous about suggesting changing the medication, if appropriate, and referring the patient to a specialist whom would then be in a position to determine exactly what is taking place. I made no assumptions regarding this patient. I simply stated the known risk regarding the drug in question as it appeared that the person asking this question was unaware of this particular adr being associated with levaquin.

As to my qualifications for making such statements I am a victim of the horrendous side effects of this class that has rendered me both blind (permanent double vision), crippled and scarred for life which took place almost a decade ago.

I have been researching this class since 2000 and have spoken to tens of thousands of patients whose lives have been destroyed by this class and the rampant ignorance found within the medical community regarding the associated safety profile. I have read well over 12,000 medical journal entries, clinical studies, the NDAs, case reports, first person reports, etc., as well as obtained thousands of documents from the FDA under the freedom of information act. I have also provided my deposition as an expert witness in an ongoing civil case involving such reactions. As well as written a number of articles and editorials concening these issues.

Should you find that this was inappropriate on my part, to share the knowledge I have obtained the hard way as a result of my own injuries in an effort to prevent what had happened to me being repeated in another, then perhaps you are correct that I should not have done so here. I do not wish to cause any arguments with you folks regarding this and I apologize if you thought my response was anything other than informed and honorable.

Your response seems to be the typical reaction I receive when ever I point out the true safety profile of this class, as found within the articles published in the leading medical journals and I have learned a long time ago not to try and debate this with others who do not share such a concern for the patient's health and welfare that I have. Hence I will say no more on the subject at hand and bother you folks no further.

 

[TexasSuxs]

Interesting.....

 

[Farmercyst]

The question asked was: How can I tell whether it's an allergic reaction or simply a side effect of the drug? For example, I had a customer complain after taking levaquin he developed a rash on his skin (he is allergic to penicillin only and he is currently not taking any other drugs). Is this a true allergy (and therefore the medication should be stopped) or is this an ADR of the antibiotic (Levaquin can cause some skin itching)?

I apologize if anyone took offense to my comments. The question being asked was whether or not this was a true allergic reaction or if this was a possible adverse reaction to levaquin. My words of caution are based upon the fact that such a rash MAY be a precursor to a serious reaction that is associated with levaquin. Such reactions include Stevens–Johnson's Syndrome, Sweet's Syndrome, T.E.N, as well as painful and disfiguring rashes.

Two types of photosensitivity reactions have been associated with fluoroquinolone therapy: photoallergic reactions and phototoxic responses. Photoallergic reactions require previous exposure to a drug in the class. In contrast, phototoxic responses can develop without previous exposure to a fluoroquinolone. Some of the fluoroquinolones induce photosensitivity reactions, such as erythema of sun-exposed skin, with varying frequency.

Photosensitivity reactions are postulated to occur as a result of fluoroquinolone photodegradation, as well as the molecule's ability to generate free monovalent oxygen radicals. In turn, these oxidative radicals may attack cellular lipid membranes, initiating inflammatory processes, and eventually produce DNA damage. Evidence for photo-induced oxidative DNA damage is demonstrated by the development of murine tumors in mice treated with Lomefloxacin. Drug-induced purpura is due to direct capillary damage or hypersensitivity reactions. (Thus to be considered vascular in nature)

Photosensitivity reactions reported with the fluoroquinolones mimic those of sunburn, with erythema and edema in the milder forms, and painful blistering with subsequent peeling when severe. A wide spectrum of cutaneous ADRs are reported with fluoroquinolones such as:

Stevens–Johnsons Syndrome
Pemphigus Vulgaris
Sweet's Syndrome (an acute febrile neutrophilic dermatosis)
T.E.N, a life-threatening skin disorder in which the top layers of skin blister and peel off in sheets.

A previous dematologic adverse reaction to a fluoroquinolone can sensitize a patient to more severe adverse reactions (with onset after only a single dose of the subsequent fluoroquinolone) as noted
earlier. Patients who develop any kind of rash to a fluoroquinolone in the past have a potential to develop life threatening photoallergic reactions when re-challenged with a fluoroquinolone drug later on in life.

Photoexposed purpuric eruptions are another side effect of fluoroquinolone therapy in addition to photosensitivity rashes. Purpura is defined as circumscribed collection of blood 0.5 cm in diameter. Morphologically it may be of several types as ecchymoses, petechiae, palpable purpura, pigmented type, or itching purpura. (In
my case such a rash has persisted for over twenty years now)

It is to be noted that within the clinical studies submitted with the initial submission of another fluoroquinolone drug, a higher than expected rate of rash was noted in these clinical studies.
During the course of the NDA review significant questions arose regarding the safety of the fluoroquinolones in this regard.

These questions centered around the higher than expected rate of rash reported in patients receiving fluoroquinolones and related questions regarding the mechanism of the observed rash, the potential for cross- sensitization, and the possibility that the frequent occurrence of rash may portend a risk for more serious infrequent cutaneous drug reactions. The drug's sponsor never provided satisfactory answers to these concerns, in my opinion. In addition, there were also unresolved questions regarding the hepatic safety profile of this class. As we see with the recent Eurpean Dear Doctor Letter concerning Avelox as well as the ongoing investigation by Health Canada regarding levaquin.

The rates of rash ranged upwards to 25% depending upon the population or subset of the population being analyzed. Analyses of this rash data have shown that female gender, age (younger adults), and longer duration of therapy are associated with an increased rate of this rash. In spite of the additional risk of the patient developing TEN, Stevens-Johnson Syndrome as well as Sweet's Syndrome, the FDA approved the drug anyhow.

The public record of the FDA meeting in which these rashes were discussed revealed several occasions where the members of the panel literally laughed out loud at patients reporting such rashes and ridiculed them. Only to find, four years later, that the real-world use of this class has shown what clinical trials previously revealed and the FDA panel members laughed at: the risk of rashes associated with the fluoroquinolones, especially for women undergoing treatment with gemifloxacin.

In 2006 the FDA convened another panel to take yet another look at the safety profile of gemifloxacin.

It was not my intention to be "preaching" here, but rather providing documented and published information regarding the fact that such rashes are not to be dismissed lightly or thought to be simply an allergic reaction that would abate upon cessation of therapy when they are induced by the fluoroquinolone class. There is a substantial risk with levaquin that it would not be just an allergic reaction. And clearly stated as such within the package insert for this drug.

What the person who asked this question now does with this information is entirely up to them..

It was not my intention to cause any kind of discord on this board, but to provide relevant information by which a person would then be able to make the correct decision. Rather unkind of you to be taking cheap shots at the messenger because you may have some issues regarding the message being delivered.

You asked: What sort of qualifications do you have to make these ridiculous recommendations and assumptions?

I am baffled as to what you find to be ridiculous about suggesting changing the medication, if appropriate, and referring the patient to a specialist whom would then be in a position to determine exactly what is taking place. I made no assumptions regarding this patient. I simply stated the known risk regarding the drug in question as it appeared that the person asking this question was unaware of this particular adr being associated with levaquin.

As to my qualifications for making such statements I am a victim of the horrendous side effects of this class that has rendered me both blind (permanent double vision), crippled and scarred for life which took place almost a decade ago.

I have been researching this class since 2000 and have spoken to tens of thousands of patients whose lives have been destroyed by this class and the rampant ignorance found within the medical community regarding the associated safety profile. I have read well over 12,000 medical journal entries, clinical studies, the NDAs, case reports, first person reports, etc., as well as obtained thousands of documents from the FDA under the freedom of information act. I have also provided my deposition as an expert witness in an ongoing civil case involving such reactions. As well as written a number of articles and editorials concening these issues.

Should you find that this was inappropriate on my part, to share the knowledge I have obtained the hard way as a result of my own injuries in an effort to prevent what had happened to me being repeated in another, then perhaps you are correct that I should not have done so here. I do not wish to cause any arguments with you folks regarding this and I apologize if you thought my response was anything other than informed and honorable.

Your response seems to be the typical reaction I receive when ever I point out the true safety profile of this class, as found within the articles published in the leading medical journals and I have learned a long time ago not to try and debate this with others who do not share such a concern for the patient's health and welfare that I have. Hence I will say no more on the subject at hand and bother you folks no further.

I know someone who suffered the severe tendonitis/rupture that was recently placed in the black box labels for cipro et al, but I'm not about to start speculating that anyone with ankle soreness is suffering from the same debilitating side effect without further research. A few citations would be more helpful.

 

[Priapism321]

I know someone who suffered the severe tendonitis/rupture that was recently placed in the black box labels for cipro et al, but I'm not about to start speculating that anyone with ankle soreness is suffering from the same debilitating side effect without further research. A few citations would be more helpful.

Your approach is perhaps prudent, however, you should caution ANY patient who is prescribed a fluorinated quinolone and begins to experience joint/ankle pain or soreness to IMMEDIATELY contact the prescribing practitioner (and maybe stop the drug, as I would guess 7/10 fluoroquinolone prescriptions are not actually necessary). This is what the warning in the new black box asks (and perhaps obligates) you to do.

 

[PharmDstudent]

you should caution ANY patient who is prescribed a fluorinated quinolone and begins to experience joint/ankle pain or soreness to IMMEDIATELY contact the prescribing practitioner

Exactly!

Black box warning states:
"at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug."

 

[BravoKilo]

Out of curiosity, can anyone here point me to the source of these claims..? All the articles I have found online simply state that the association between FQs and tendon rupture exists, without providing any actual data to support it.

 

[davidtfull]

The citations can be found by following these links depending upon what adverse reaction you have an interest in. Regarding tendon ruptures and the fluoroquinolones not ONE year has gone by since 1982 that this reaction was not published in any one of the leading medical journals. Nor is this speculation by any means, but proven medical fact with numerous studies detailing the suspected mechanism of action. Several of which are a couple of decades old.

Each link being provided will open a window similar to what you find on PubMed listing the various citations that you would click on to read. Not all citations have the complete article, some only an abstract and others nothing more than the article name and authors. But when one views these citations as a whole a very clear picture begins to form. You do not find this vast amount of research going back from when the class was first introduced with "safe and effective drugs with minimum side effects", but rather with a potent and toxic drug that should be used with extreme caution and the patient carefully monitored for presentation of any of these events.

Not preaching here by any means, but the patient usually presents with any combination of these reactions which, due to the number and severity, are often times attributed to anything but the fluoroquinolones for few physicians have any idea of this safety profile and cannot believe that the drug is responsible. As I had stated in a previous post I have no desire, or interest in debating the pros and cons of fluoroquinolone therapy. All I am attempting to do is provide the research and you folks decide amongst yourselves what to do with it.

Hopefully you will have gain a new perspective concerning this class and will be treat it with the respect and caution it deserves. Or you will do nothing, ignore these links and citations, and continue on as before as if I had never been here. But keep in mind when viewing my comments that I have read EACH AND EVERY one of the citations listed here. And it is from that perspective that my comments are to be viewed from, not as if I was to be considered some chicken little claiming that the sky is falling. Even within the Merck Manual this class is listed as a chemotherapeutic agent. That should be a head's up all in itself that it is something other than your average antibiotic.

Muscle Damage & Tendon Ruptures
http://fqresearch.org/tendon_muscle_pain.htm

Phototoxicity and Skin Damage
http://fqresearch.org/rashes.htm

Rhabdomyolysis
http://fqresearch.org/rhabdomyolysis.htm

Anxiety
http://fqresearch.org/anxiety.htm

Brain Damage
http://fqresearch.org/brain_damage_archives.htm

Blood Disorders
http://fqresearch.org/blood_disorders_archives.htm

Irreversible Peripheral Nueropathy
http://fqresearch.org/burning_pain.htm
http://fqresearch.org/cns_pns_archives.htm

Caustation
http://fqresearch.org/caustion_archives.htm

Drug Interactions
http://fqresearch.org/drug_interactions.htm

Depersonalization
http://fqresearch.org/depersonalization.htm

DNA Damage
http://fqresearch.org/dna.htm

Gastrointestinal Damage
http://fqresearch.org/gastrointestinal_archives.htm

Hearing Loss
http://fqresearch.org/ears.htm

Hypo / Hyperglycemia
http://fqresearch.org/sugar.htm

Heart Damage
http://fqresearch.org/heart.htm

Pediatric Use
http://fqresearch.org/pediatric_research_archives.htm

Kidney Damage
http://fqresearch.org/kidney_damage_archives.htm

Liver Damage
http://fqresearch.org/liver.htm

Obstetrics
http://fqresearch.org/baby_archives.htm

Severe Pain
http://fqresearch.org/pain.htm

Seizures
http://fqresearch.org/seizures.htm

Sleep Disturbances / Insomnia
http://fqresearch.org/insomnia.htm

Special Senses
http://fqresearch.org/special_senses_archives.htm

Toxic Psychosis and Delusions
http://fqresearch.org/toxic_psychosis_archives.htm

Urological Damage
http://fqresearch.org/urology_archives.htm

Vasculitis
http://fqresearch.org/vasculitis_archives.htm

Vision Damage and Blindness
http://fqresearch.org/vision.htm

Having taken the time to compile this list, perhaps someone here could explain to me why we find such resistance within the medical community believing that this class can cause such severe reactions. It seems when ever this information is presented we still find those who deny this relationship and defend this drug as being both safe and well tolerated. Efficacy is not at issue here, though an argument can be made that this class is no better than that which it had replaced. I do not advocate removing this class from clinical use, but rather providing adequate and realistic warnings. But why the total and complete resistance found regarding providing adequate warnings, and then responding accordingly when a patient has such reactions?

We even find it here on this discussion board regarding the tendon ruptures and the severe skin reactions. A proven medical fact that some continue to be in denial concerning something that has been reported for two and one half decades. I would be forever grateful if someone would take the time to explain this paradox to me, for I truly cannot understand this as it defies both logic and common sense. And it certainly has not been from lack of effort on my part.

 

[medicalCPA]

N00b here, with a totally irrelevant observation.

There's a Fluoroquinolone Toxicity Research Foundation? Why doesn't a Foundation to Send Medicalcpa to Pharmacy School exist? (seriously...)

 

[TexasSuxs]

N00b here, with a totally irrelevant observation.

There's a Fluoroquinolone Toxicity Research Foundation? Why doesn't a Foundation to Send Medicalcpa to Pharmacy School exist? (seriously...)

Create one.....No one is going to do it for you....

 

[slaitken]

"Chemotherapeutic" actually refers to agents that are active against living organisms, either microbial or cancerous. By definition, all classes of antibiotics are chemotherapeutic.

Fluoroquinolones, like any other prescription medications, have the potential to cause adverse reactions. The prescriber must weigh the side effects of the medications must be weighed against the benefits incurred by using them. Some of the reactions listed are exceedingly rare within the class, others are found more commonly in other antibiotics or other therapeutic classes all together. The fluoroquinolones can be dangerous, but so are any foreign substances that enter the body.

Information on these side effects have been provided to the medical community, as well as a new "Black Box" warning. Providers are well aware of them, and factor them into their clinical judgment every time a prescription is written or dispensed.

I do appreciate the articles you've provided, however, I still question your qualifications to provide them.

 

[davidtfull]

Question all you care to. Makes no difference to me.

But you stated that "Providers are well aware of them, and factor them into their clinical judgment every time a prescription is written or dispensed." Simply not true when it comes to this class.

You will notice that this whole thread started with someone posting about a common adr to levaquin that they had no prior knowledge of.

When the victims of these serious reactions were asked if their treating physicians had ANY PRIOR KNOWLEDGE concerning the adverse reactions that they were experiencing being related to the fluoroquinolones, known listed and published reactions, less than 1% responded in the affirmative. 99% of the treating physicians had no clue. So how then would a physician factor in an adverse reaction when they have no prior knowledge of it to begin with?

'Some of the reactions listed are exceedingly rare within the class'

lets pause here for a moment.

If a physician does not associate the reaction to the medications in the first place what are the odds that he will report it as such? Zero my friend. So such statistics are meaningless. 1000's of events and only ONE reported does not make something rare. What becomes rare is the fact that it was even reported to begin with.
Less than 4% of any drug reaction is ever reported to the FDA. 96% never make it that far. And of this 4% the FDA only retains 25% or so. The rest get tossed and never make it into the Med Watch database.

'...others are found more commonly in other antibiotics or other therapeutic classes all together.' Will grant you this one but that is still no excuse NOT to inform the patient. Barfing and bitching can be found with any drug under any circumstances. But we are not discussing barfing and bitching here. We are discussing crippling and fatal reactions. BIG difference.

'The fluoroquinolones can be dangerous, but so are any foreign substances that enter the body.' True again. Arsenic is dangerous as well. So where is the logic that allows a physician to prescribe a drug when he has no clue regarding the potential adverse reactions without FIRST becoming informed regarding the risk that they are now putting their patient to? Again, where is the logic that allows such careless scripting that we see with this class?

In one ER setting the fluoroquinolones were examined for proper use and proper dosage. Only 1% of the scripts was for the correct indication at the correct dose. 99% of the treating physicians got it wrong.

You're assertion that 'Providers are well aware of them, and factor them into their clinical judgment every time a prescription is written or dispensed' simply does not hold water. In an ideal world this is how it should work. But in reality the exact opposite takes place. You would be absolutely SHOCKED, APPALLED and EMBARASSED to even be a part of the medical community if you were to read what some physicians have said to the patients who have presented with these reactions.

The NUMBER ONE COMPLAINT of all those who have had a reaction is the fact that their treating physicians REFUSED to associate this with the fluoroquinolones. Flat out refused to even read some of the citations I have provided here. They lose it my friend, absolutely lose it whenever someone tells them these drugs are less than perfect.

Q "…would you agree that as a general proposition that if language appears in the warnings section in boldface it is more likely that doctors will take heed of that information than if it's put back in the postmarketing surveillance section and it's not in boldface?"

A "Well, my experience would be that doctors just don't look at the label, period." TADATAKA YAMADA, M.D., the administrative head of the research and development, SmithKline Beecham.
Source: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF WYOMING
TOBIN, et al vs. SMITHKLINE BEECHAM: NO. 00CV0025

It is obvious by your couple of post on this subject that your mind is made up and you would prefer not to be further confused by the facts. I will try no further. As such I would have to respectfully disagree with you while agreeing with Tadataka Yamada, and we will simply have to agree to disagree.

As to my qualifications you have failed to consider the fact that I am the patient. I am the one you are being trained to pay attention to in the first place.

Anyhow my disagreements with you are strictly philosophical and not personal in the least. Continue on as you see fit. I just hope that you would find something of value within the links I provided, is all. And perhaps you are the one rare exception that proves every rule and will indeed carefully weight the risk as well as the benefit of a drug before employing it. If so then it has been a pleasure to converse with you.

If not, well you are far more of a menace to the patient than these drugs could ever be.

 

[BravoKilo]

Again, I'm always one for verifiable sources.... care to provide them for all the claims you just made?

When the victims of these serious reactions were asked if their treating physicians had ANY PRIOR KNOWLEDGE concerning the adverse reactions that they were experiencing being related to the fluoroquinolones, known listed and published reactions, less than 1% responded in the affirmative. 99% of the treating physicians had no clue. So how then would a physician factor in an adverse reaction when they have no prior knowledge of it to begin with?

And am I correct in reading that the PATIENTS were polled in regards to the physician's knowledge of the subject, and not the prescribing physicians in the first place? Seems a bit biased and misinformed to me.

And the 99% error in FQ scripts.... what were the guidelines in determining correct/incorrect dosing? And in regards to dosing (for any drug for that matter), there are a multitude of variables to factor in that wouldn't make it that hard for someone trying to prove an agenda say it is "wrong" to make the numbers show up in their favor.

 

[davidtfull]

You request for citations is understandable and I am more than happy to comply:


Fluoroquinolone Utilization in the Emergency Departments of Academic
Medical Centers

Prevalence of, and Risk Factors for, Inappropriate Use

Ebbing Lautenbach, MD, MPH; Lori A. Larosa, PharmD; Nishaminy
Kasbekar, PharmD; Helen P. Peng, PharmD; Richard J. Maniglia, MD;
Neil O. Fishman, MD

Arch Intern Med.2003;163:601-605.

Background Resistance to fluoroquinolone (FQ) antibiotics has risen markedly in recent years and has been associated with increasing FQ use; however, few data exist regarding FQ use patterns. Designing strategies to limit FQ resistance byoptimizing FQ use depends on identifying patterns of inappropriate FQ use. Use of FQs in emergency departments (EDs) has not been studied.

Methods


We studied 100 consecutive ED patients who received an FQ and were subsequently discharged. Appropriateness of the indication for use was judged according to existing institutional guidelines. A case- control study was conducted to identify the prevalence of, and risk factors for, inappropriate FQ use.

Results

Of 100 total patients, 81 received an FQ for an inappropriate
indication. Of these cases, 43 (53%) were judged inappropriate
because another agent was considered first line, 27 (33%) because
there was no evidence of infection based on the documented
evaluation, and 11 (14%) because of inability to assess the need for antimicrobial therapy. Although the prevalence of inappropriate use was similar across various clinical scenarios, there was a
borderline significant association between the hospital in which the
ED was located and inappropriate FQ use. Of the 19 patients who
received an FQ for an appropriate indication, only 1 received both
the correct dose and duration of therapy.

Conclusions

Inappropriate FQ use in EDs is extremely common. Efforts to limit
emergence of FQ resistance must address the high level of
inappropriate FQ use in EDs. Future studies should evaluate the
impact of interventions designed to reduce inappropriate FQ use in
this setting.


Additional reference: [Use of levofloxacin in the hospital] [Utilizacion hospitalaria de levofloxacino.] Rev Esp Quimioter 2003 Jun;16(2):221-6 (ISSN: 0214-3429) Castells X; Vallano A; Campany D; Rigau D; Arnau JM Servicio de Farmacologia Clinica, Fundacio Institut Catala de Farmacologia, Barcelona, Spain.

Cipro, Related Antibiotics Over-Prescribed...A new study heightens concerns that Cipro and related broad-spectrum antibiotics known as fluoroquinolones are being over-prescribed...



In regards to the other study you are more than welcome to review the raw data by following this link:
http://************/627v2a



We present a brief survey on the fqresearch site which asked the following questions of the patient:

1. Unique Identifier (enter a unique name or other identifier: DO NOT use your screen name or real name.
2. Drug prescribed:
3. Type of physician who prescribed the drug (example, internist, general practioner, specialist, emergency room physician, surgeon, etc.)
4. Adverse Events you feel may be related to this drug:
5. Physician’s reaction to your concerns:
6. Did your physician exhibit ANY prior knowledge concerning the adverse reactions associated with the fluoroquinolones?
7. Was your physician willing to admit that the drug could possibly be responsible?
8. Where you given any advice as to what side effects you may experience?
9. Did the physician enter into a risk/benefit discussion prior to prescribing the drug?
10. Was the drug prescribed for "off label" use (meaning NOT an approved use)?
11. Was testing done to confirm or deny the presence of a bacterial infection?
12. What reason(s) was the drug prescribed?
13. Did you receive any benefit from being on this drug?
14. How did you find the fqresearch site?
15. What made you log unto the site?
16. Was the information you found of any value to you?
17. Additional comments or concerns you may have:
Thank you for taking the time to fill out this survey. Your participation is appreciated and is very important in documenting the adverse drug reactions you may have experienced. It is strongly recommended that in addition that you fill out a medwatch report as well.


As I had mentioned in my other comment you will be both shocked and appalled by the responses we received, as well as embarassed to call yourself a member of the medical community after reading these responses. You had stated that:
'And am I correct in reading that the PATIENTS were polled in regards to the physician's knowledge of the subject, and not the prescribing physicians in the first place? Seems a bit biased and misinformed to me.'

But I fail to understand your logic as to why you would consider that so. No more bias and misinformed than what we find within any clinical study, where the patient is ignored and we rely upon the 'judgment' of the physician as to whether or not the patient felt they had suffered a reaction, rather than asking the patient.

The whole issue is lack of proper warnings being given to the patient as well as the treating physician. So whether the patient percieved to have recieved adequate warnings would only be a question that the patient could answer. Not the physician.

Should the physician have failed to enter into a risk/benefit discussion that the patient UNDERSTOOD, it would have been the same as if no discussion took place in the first place.

If you would note we asked what the Physician’s reaction to their concerns was, whether or not the physician was willing to admit that the drug could possibly be responsible, and whether they were given any advice as to what side effects they may experience. As well as specifically asking whether the treating physician had entered into a risk/benefit discussion prior to prescribing the drug. All questions that only the patient would be in a position to answer, not the physician. Nothing suggestive in these questions that would influence the patient's response either. Either something took place or it did not.

All of the knowledge in the world is for naught if it is not shared with the patient in such a manner that the patient understands both the risk as well as the benefits of any given therapy. As you will see by these responses the physician has failed miserably in his or her obligation to the patient.

Granted this is not scienctific by any means. Not something that one would consider for peer review and publication. No doubt some responses are from some kid who was bored to death one night and decided to yank our chain. But there are simply far too many detailed responses that one could not consider to be anything but the real deal.

We find the very same complaints from all over the world on all the adverse drug reaction forums dealing with this issue, and these patients have been stating the exact same thing since 1982. NOTHING has changed in the past couple of decades except the name of the patient.

I would also like to add, for you may not be aware of this at the moment, they have recently restricted the use of Avelox over in Europe due to the severity of the adverse reactions as well as restricted the use of Norfloxacin for the same reason as well as the fact that it failed to show any efficacy for certain infections it has been used to treat. I rather doubt that you will find any "Dear Doctor Letters" in your mailbox anytime soon explaining this either. Bayer has already stated that they will NOT be issuing the European Dear Doctor Letter here in the States. Citation required once again no doubt? Happy to oblige:

Last week, FDA’s European counterpart, the European Medicines Agency (EMEA), recommended strengthening the warnings for oral moxifloxacin medicines.
Moxifloxacin is a fluoroquinolone antibiotic. EMEA concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.
The recommendation came out of EMEA’s Committee for Medicinal Products for Human Use (CHMP) after committee members reviewed information on the safety of moxifloxacin-containing medicines for oral use, following concerns over their liver safety, according to an EMEA press release.
CHMP concluded that “the benefits of oral moxifloxacin medicines continue to outweigh its risks.” However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, CHMP recommended restricting their use in these indications. CHMP also recommended that the warnings of oral moxifloxacin-containing medicines be strengthened concerning the risk of diarrhea, heart failure in women and older patients, severe skin reactions and fatal liver injury.
The committee’s recommendation will be considered by the full European Commission (EC). If the EC agrees with the committee, additional warnings may soon be applied to all authorized oral moxifloxacin-containing medicines in the European Union.
Affected fluoroquinolone drugs include: Cipro, Cipro XR and Proquin XR, Factive, Levaquin, Avelox, Noroxin and Floxin, and generic ofloxacin. Affected moxifloxacin drugs include Actimax, Actira, Avelox, Havelox, Infekt, Izilox, Moxifloxacin, Octegra and Proflox.

LONDON -- July 24, 2008 -- The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections.

The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for oral norfloxacin-containing medicines, when used in the treatment of acute or chronic complicated pyelonephritis, should be withdrawn because the benefits of these medicines do not outweigh their risks in this indication.

This is based on the fact that the efficacy has not been adequately demonstrated for this type of infection.

The CHMP review of norfloxacin medicines was initiated on the request of the Belgian medicines regulatory agency. They questioned the efficacy of oral formulations of the medicine for complicated pyelonephritis in comparison with other fluoroquinolones.

Following evaluation of information provided by the companies, the CHMP, at its July 2008 meeting, noted that there was not enough clinical data to demonstrate the efficacy of oral treatment with norfloxacin-containing medicines in complicated pyelonephritis.

Therefore, the CHMP concluded that the use of oral norfloxacin-containing medicines in the treatment of acute or chronic complicated pyelonephritis could no longer be supported.

The recommendation of the CHMP does not have an impact on the use of oral norfloxacin-containing medicines in other types of infection.

Doctors should not prescribe oral norfloxacin for complicated pyelonephritis and should consider switching patients already taking oral norfloxacin for this type of infection to an alternative antibiotic.

SOURCE: The European Medicines Agency [SIZE=-1][/SIZE]

Let us not forget as well that the CDC has also stated quite a while ago that these drugs are useless for treating certain STD's as well. But the urologist keeps on writing scripts for these particular STD's anyhow. Running out of room here but if you require that citation as well I will add to my next comment. That is if we are stilling talking to each other after this post.

 

[davidtfull]

Obivously you would view all of this from a far different perspective than I, and I do respect and even appreciate that. No question that I am bias in my comments, which I freely admit. After what I have endured since 1984 it is impossible not to be, though I do make an honest effort most of the time. But these comments from a local newspaper pretty much sums up this whole mess that we are trying to make some sense of:

As reported in a local newspaper physicians plan on blowing off this black box warning anyhow:

‘Local physicians say they still plan to prescribe the antibiotic Cipro and similar drugs despite the government's recent warning that the medicines could cause tendon infections and rupture.

"I'm very comfortable prescribing it," said Dr. Bruce Leibert, Harlingen family practice physician. "I have yet to hear of any tendon effects on adults ... and we've had very good successes with it."


(Even though it clearly stated that this class is NOT to be used within the pediatric population Dr. Jorge rather convincingly contradicts himself when he states the following while ignoring this caveat found within the package inserts)

A Brownsville physician said he thought the FDA's decision to add a black-box warning "might be an overreaction."
"If (the antibiotic) is used the way it should be used, it shouldn't harm anyone," said pediatrician Dr. Jorge Dominguez, who prescribes the drug occasionally for teenagers older than 14.

Dr. Lorenzo Pelly, Brownsville internal medicine specialist. Pelly more often prescribes Levaquin, another fluoroquinolone. Pelly considers it a safe drug and has never seen adverse effects in patients, he said.

(But I would be willing to bet the farm that if we were to ask Dr. Pelly’s patients whether or not they suffered an adverse reaction the answer would be in the affirmative in any number of cases)

Reminds me of the three monkeys, hear of no reactions, see no reactions…

Being a mind reader I can alread tell that someone is going to say that being 14 years old is old enough not to be worrying about the damage we find with the beagle studies that showed cartilage damage. Wrong again.

I just received a report of a 14year old male who tore the cartilage in both knees requiring extensive surgical intervention as a result of being on levaquin to treat a nail infection. The treating physician failed to associate the severe pain in the knees that the patient reported as being a possible adr to levaquin and prescribed the drug not once, but twice. Ignoring the warning found within the package insert that the drug was to be STOPPED when the patient complained of joint pain. Instead he was referred to rheumatologist for treatment and bounced from doctor to doctor. The ONLY doctor that had any knowldege concerning this being related to levaquin was the surgeon who tried to repair the kid's knees. Full recovery is very doubtful in this case and additional surgeries will be required in the future.

Rather steep price to pay to treat a minor infection of the nail that just about any other antibiotic would have handled with no problem. Not to mention the young lady who has been in a wheelchair for the past decade due to the damage done to her tendons which rendered them beyond surgical repair. She was given cipro for an earache while in her early teens and once again no association made to the medication and the horrendous damage done to her tendons that has now crippled her for life.

Both case studies I plan on submitting to the New England Journal of Medicine and other such publications once the peer review is completed. This my friends is the norm, not the exception, as the first year (or is it second) attempted to state in his response. Happens every day of the week since 1982.