Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
On January 12, 2022, FDA warned 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. Despite these risks, buprenorphine is an important treatment option for opioid use disorder and pain, and the benefits of these medicines clearly outweigh the risks.
Regular adherence to buprenorphine to treat opioid use disorder reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat opioid use disorder. This approach, called medication-assisted treatment, is tailored to meet each patient’s needs and can help sustain recovery and prevent or reduce opioid overdose. According to the U.S. Substance Abuse and Mental Health Services Administration, medication-assisted treatment has been shown to be effective in improving patient survival, decreasing opioid use, and allowing patients to live a self-directed life, including the ability to gain and maintain employment.
We are requiring a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth. The prescribing and patient information will also include strategies to maintain or improve oral health while undergoing treatment with these medicines. These strategies will include recommending that prescribers refer patients to dental care services and encourage them to have regular checkups while taking these products. Patients should tell the dentist about all medicines they take, including buprenorphine.
Health care professionals should 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. Patients should be advised to wait at least 1 hour before brushing their teeth. 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.
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 or published in the medical literature, so there may be additional cases about which we are unaware. 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 opioid use disorder; 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 diagnosis being approximately 2 years after starting treatment. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events. Of the 305 cases, 113 mentioned two or more teeth were affected. The most common treatment for these dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases reported requiring root canals, dental surgery, and other procedures such as crowns and implants.
All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking a medicine outweigh the risks. It is important to know that people respond differently to all medicines depending on their health, other medicines they are taking, the diseases they have, genetic factors, and many other reasons. As a result, we cannot determine how likely it is that someone will experience these side effects when taking buprenorphine medicines that dissolve in the mouth. However, the benefits of buprenorphine medicines for opioid use disorder and pain management clearly outweigh the risks. In particular, the comprehensive medication-assisted treatment approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat opioid use disorder, and can help sustain recovery and prevent or reduce opioid overdose.
Side effects involving buprenorphine should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
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