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FDA Warns That Belbuca

FDA Warns That Belbuca, Suboxone, and Zubsolv are Associated With Tooth Loss and Other Significant Dental Problems 

January 13, 2022 | 2 min read


On January 12, 2022, the FDA warned patients and prescribers about the potential for serious dental problems associated with the use of medications containing buprenorphine, such as Belbuca, Suboxone, and Zubsolv. According to the alert, the FDA is already aware of over 300 cases of dental problems, of which 131 have been classified as serious. The dental problems reported include dental abscesses, oral infections, tooth decay, and even total loss of teeth.

Buprenorphine is an opioid that works by changing the way an individual responds to pain. It has been approved to treat opioid use disorder (OUD) and pain. Buprenorphine medicines can be delivered in many different ways: skin patches, injections, tablets, and films. However, the buprenorphine medicines intended to dissolve in the mouth (i.e. tablets and films) have been reported to cause serious dental problems. They include brand names Belbuca, Suboxone, and Zubsolv.

In response to the numerous reports of dental problems, the FDA is requiring the addition of a new warning about the risk of dental problems on the prescribing information and patient medication guide for all buprenorphine medicines that dissolve in the mouth. Patients are advised to visit a dentist soon after starting the medicine, as tooth loss or infections can occur even if the patient had no prior history of dental problems.

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