FDA Warns about Dental Problems with Buprenorphine Medicines
Posted 01/12/2022
FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat OUD and pain.
FDA is drawing attention to dental problems linked to buprenorphine-containing medications that are dissolved under the tongue or placed against the inside of the cheek to treat opioid use disorder (OUD) and pain. Even patients with no prior history of dental problems could develop severe tooth decay, cavities, and oral infections and possibly even lose some teeth. FDA is requiring a new warning on prescribing information and other literature to alert patients and providers; however, based on the favorable risk-benefit profile, it still considers buprenorphine to be an important and viable treatment option. The regulator recommends that health care providers and patients have a conversation about oral health before initiating treatment with transmucosal buprenorphine. Providers should counsel patients on steps for reducing the risk of serious dental complications, such as gently rinsing mouth with water after taking the medicine and waiting at least 1 hour before brushing their teeth, and refer them to a dentist. Patients should discuss their buprenorphine regimen with the dentist and schedule regular checkups during the duration of treatment. Any problems should be entered into FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
