FDA warns of dental problems associated with certain buprenorphine medications

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 and pain.

Even patients with no prior history of dental problems could develop severe tooth decay, cavities, and oral infections, the agency said. Individuals could even lose some teeth.

FDA is requiring a new warning on prescribing information and other literature to alert patients and providers to this side-effect. However, it still considers buprenorphine to be an important and viable treatment option based on the favorable risk-benefit profile. 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 the mouth with water after taking the medication and waiting at least 1 hour before brushing teeth. Providers can also make a referral to a dentist.

Patients should discuss their buprenorphine regimen with a 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.