The Food and Drug Administration (FDA) on January 12 said it will require a warning about possible dental problems caused by dissolving buprenorphine in the mouth – the main route of administration for the opioid use disorder (OUD) treatment medication.
The dental problems include tooth decay, cavities, oral infections, and tooth loss.
This does not mean patients should stop taking their buprenorphine or that prescribers should make any treatment changes, beyond discussing oral health with people taking the medication, according to the FDA, which said that despite the risks of dental problems, buprenorphine’s benefits outweigh the risks.
Buprenorphine is also used in the treatment of pain.
“Regular adherence to buprenorphine to treat OUD reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse,” according to the FDA.
The new warning will be added to the prescribing information and the patient medication guide for all buprenorphine-containing medications dissolved in the mouth. Both documents will include strategies to maintain or improve oral health while taking these medications, including recommendations that prescribers refer patients to dental care and encourage them to have regular checkups. Patients should tell their dentists about all the medications they take, including buprenorphine, according to the FDA.
Recommendations for patients:
After the medicine is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. You should wait at least 1 hour before brushing your teeth to avoid damage to your teeth and give your mouth a chance to return to its natural state.
Schedule a dentist visit soon after starting this medicine and inform your dentist that you are taking buprenorphine, and schedule regular dental checkups while taking this medicine. Your dentist can customize a tooth decay prevention plan for you. Notify both your health care professional and your dentist immediately if you experience any problems with your teeth or gums.
Recommendations for prescribers:
Ask patients about their oral health history prior to prescribing treatment with a transmucosal buprenorphine medicine. These serious dental problems have been reported even in patients with no history of dental issues, so refer them to a dentist as soon as possible after starting transmucosal buprenorphine.
Counsel patients about the potential for dental problems and the importance of taking extra steps after the medicine has completely dissolved, including to gently rinse their teeth and gums with water and then swallow.
Recommendations for dentists:
Dentists treating someone taking a transmucosal buprenorphine product should perform a baseline dental evaluation and caries risk assessment, establish a dental caries preventive plan, and encourage regular dental checkups.
What the FDA found
Since buprenorphine was approved, we identified 305 cases of dental problems (131 cases classified as serious) with buprenorphine medicines dissolved in the mouth. These only include cases reported to FDA and reported in the medical literature.
The average age of the patients was 42 years, but those as young as 18 years were also affected. Most cases were in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.
In 26 cases, patients had no prior history of dental problems. Some cases reported dental problems occurring as soon as 2 weeks after treatment began, with the median time to the diagnosis being approximately 2 years after starting treatment. The most common treatment for these dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases were reported requiring root canals, dental surgery, and other procedures such as crowns and implants.
