FDA issues warning for certain Buprenorphine medications

February 17, 2022 · Clinical Team

The U.S. Food and Drug Administration (FDA) issued a warning on January 12, 2022, regarding a potential risk of dental problems with orally-dissolving buprenorphine medications. Buprenorphine is a mixed opiate agonist-antagonist used to treat opioid use disorder (OUD) and pain.

Reported dental problems may include tooth decay, cavities, dental infections or abscesses, tooth erosion and, in some cases, total tooth loss. The buprenorphine-containing medications associated with dental problems are tablets and films dissolved under the tongue (sublingual) or placed against the inside of the cheek (buccal).

Because of this, the FDA will require a new warning be added to the prescribing information and Medication Guides for all buprenorphine-containing medications that are dissolved in the mouth. In addition, the agency states the benefits of buprenorphine medications clearly outweigh the risks and oral care can help. Therefore, prescribers should encourage their patients to practice good oral hygiene and see a dentist if they are taking these medications.

Medications impacted by this warning

These medicines may be available under a brand-name or generic as a single-ingredient buprenorphine tablet (e.g., Subutex®) or film (e.g., Belbuca®), and when buprenorphine is combined with naloxone in a tablet or film (e.g., Suboxone®, Bunavail®, Zubsolv®).

Medications not impacted by this warning

The FDA has not identified this concern with buprenorphine medications delivered through the skin (e.g., Butrans® or buprenorphine transdermal patch) and by injection (e.g., Buprenex®, Sublocade®).

Impact on workers’ compensation and auto no-fault industry

According to treatment guidelines, orally-dissolving, buprenorphine-containing medications may be appropriate in certain situations for the treatment of OUD or pain. Injured persons should talk to their prescribers, use preventive measures to reduce the risk of dental problems, and consider the following:

Continue taking your medication as prescribed and talk to your prescriber.
After the medication is completely dissolved, take a large sip of water, swish it gently around the teeth and gums, and swallow. Wait at least one hour before brushing teeth after use.
Let your dentist know if you are taking a buprenorphine-containing product that should be dissolved in the mouth (under the tongue or inside the cheek).
If you do not have a dentist, visit a dentist to develop a preventative strategy, including close monitoring by the dentist and regular checkups.
Notify your prescriber and dentist immediately if you have any problems with your teeth or gums.

For more information about this warning, click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

U.S. Food and Drug Administration (FDA). Drug Safety Communication. FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. January 12, 2022.
ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed January 18, 2022.