February 21, 2022

FDA Issues Warning for Dental Problems with Dissolvable Buprenorphine Products

The FDA has issued a warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. While this does pose a potential issue, FDA stated that the benefits for the use of buprenorphine outweigh the risks of dental problems, and oral care can help.

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. Buprenorphine is an opioid used to treat pain as well as to help individuals with opioid-use disorder (OUD) reduce opioid use.

The buprenorphine medicines that are associated with dental problems are tablets and films dissolved under the tongue or placed against the inside of the cheek.  They are available as single-ingredient products, as well products that combine buprenorphine with naloxone. Buprenorphine medicines are marketed under the brand names Belbuca, Bunavail, Cassipa, Suboxone, Subutex, and Zubsolv.  They are also available as generics.

The FDA will now require a new warning for dental problems to 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 their dentists about all medicines they take, including buprenorphine.   

For an up-to-date, interactive view of drug approvals and safety alerts impacting workers’ comp, visit Healthe’s MedMonitor website.

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