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WHAT IS THE FDA WARNING ABOUT BUPRENORPHINE PRODUCTS (SUBOXONE/SUBUTEX)?

In January of 2022 the FDA released a warning about buprenorphine products being associated with dental decay. FDA also gave further explanation about this warning here.

Some quotes from the FDA warning:

The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.

Some cases reported dental problems occurring as soon as 2 weeks after treatment began, with the median time to diagnosis being approximately 2 years after starting treatment. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events.


CAN I SEE THE REPORTS OF ADVERSE EVENTS OTHER PEOPLE HAVE MADE?

Yes! The FDA has a website called FAERS (FDA's Adverse Event Reporting System). Anyone can search reports of adverse events on this website.

Here is are some FAQ's about FAERS


WHAT DO I DO IF I HAVE A SUBOXONE RELATED DENTAL INJURY?

Instead of e-mailing Claudia or Bev your information about your dental injury, please take the following steps:

1. Please report your dental injury on the FDA's MedWatch website.

"MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:

  • Prescription and over-the-counter medicines
  • Biologics such as blood components, blood/plasma derivatives and gene therapies.
  • Medical devices such as hearing aids breast pumps, and pacemakers.
  • Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray.
  • Special nutritional products such as dietary supplements, medical foods and infant  formulas.
  • Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
  • Food such as beverages and ingredients added to foods."

2. Please fill out the form on this website about dental issues and Suboxone (it is at the end of the content).

3. You will need dental records from prior to your use of Suboxone (bupe) and after you started the medication.

  • Please start requesting these now as the law firm can't evaluate your case without them.


IS THERE A LAWSUIT ABOUT DENTAL INJURY FROM SUBOXONE (BUPRENORPHINE)?

  • There is a law firm interested in this issue.
  • Read this website about dental injuries and Suboxone created by the lawyer to have your situation evaluated.
  • We will post the website here when it goes live on Tuesday, May 31, 2022.

WHAT DOES ANDREW KOLODNY AND PROP HAVE TO SAY ABOUT THIS ISSUE?

Kat Marriot, the Executive Director of PROP had this to say about Suboxone and dental injuries:

Kat Mariot sub tooth comment


PETITION FROM ADDICTION ORGS FOR FDA TO RETRACT THE WARNING

Interestingly, about ten addiction organizations (many that take money from Indivior) quickly petitioned the FDA to retract the warning. Their point is that Suboxone saves lives of those with Opioid Use Disorder, and this warning can discourage people from taking the medication. It's ironic because these same organizations are the ones helping to sue Purdue and other pharma companies for hiding possible negative side effects of opioids for pain. I suspect many of these orgs will also be getting some of the billions in settlement funds from the multi district litigation against pharma.

We 100% understand that this medication saves lives of those with OUD. Does that mean they don't have a right to know what can happen to their teeth? Dental care is extremely expensive, and can cost tens of thousands of dollars. Who can afford that? People with addiction have a right to know the possible side effects of this medication. The other issue is Suboxone/Subutex is being pushed on people in pain. It absolutely works for some people, and we support its use as an option. Unfortunately, it's often not given as AN option it's given as THE ONLY option even to patients who are stable on full agonist opioids. Don't CPP's have a right to know what can happen to their teeth especially if they're told their options are Suboxone or nothing? 

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Claudia A. Merandi 5 Chedell Avenue / East Providence, RI 02914 / USA 1.401.523.0426

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