FDA: Dissolvable Buprenorphine Medicines Linked to Potential Dental Issues

[khankjkhan]

---

Members don't see this ad.

https://tinyurl.com/yztzffeb

i dont know what to say.

 

[drusso]

https://tinyurl.com/yztzffeb

i dont know what to say.

 

[kstarm]

"Patients may lessen their risk of dental problems by taking certain preventative measures. After the product is completely dissolved, patients should take a large sip of water, swish it gently around their teeth and gums, and swallow, waiting for at least one hour before brushing their teeth after use of the product to avoid damage to the teeth. Patients should also visit a dentist to develop a preventative strategy, including close monitoring by the dentist and regular dental checkups"

 

[Pain Applicant1]

I live in an underserved rural area. I'll go out on a limb and say that I think dental hygiene is probably not the first thing on the list for my peeps around here.

Benefits far outweigh the risk anyway, at least for here.

 

[Pain Applicant1]

Honestly, what other options exist for these folks?

Warn the pt on the potential risk of dental issues and have them determine whether or not the risk is worthwhile.

 

[au bon pain]

I live in an underserved rural area. I'll go out on a limb and say that I think dental hygiene is probably not the first thing on the list for my peeps around here.

Benefits far outweigh the risk anyway, at least for here.

Yup...and what is their baseline dental status confounding this??

Honestly, what other options exist for these folks?

Warn the pt on the potential risk of dental issues and have them determine whether or not the risk is worthwhile.

Exactly. This is so unbelievably dumb. The link below is to the FDA's more in-depth "review" of this. It is trash. There is no prospective study to attempt to show causation--yet the FDAs wording implies causation. And what's the # of this mass affliction of "dental problems" they're reporting on??

305 cases

And what's their n? Well by their methods it's all patients who have ever used bup since it was FDA approved in 2002 since they include FAERS data (about as pure GIGO as you can get) ... so these 305 cases are out of a pool of maybe 10-20 million patients (or maybe way more?) patients. Assuming the low end, that's an incidence of this = 0.0000305% of somebody maybe needing a crown, which I'd guess is way lower than an average American's yearly risk of needing a crown.

Their headline causes needless fear mongering for a med that's already needlessly stigmatized...and which also happens to be perhaps the most useful opioid on the planet. Thank you FDA

Buprenorphine dissolved in the mouth can cause dental problems

Benefits for use outweigh these risks and oral care can help

www.fda.gov