The federal agency said it identified 305 cases of dental problems such as tooth decay, cavities, oral infections and tooth loss in patients. Twenty-six of the cases were patients with no history of dental issues. The average age of the patients who had dental problems was 42 years old, although the FDA said cases were also reported in those as young as 18.
But the benefits of buprenorphine for treating opioid use disorder continue to outweigh the risks, the FDA claims.
The FDA said it is requiring that a warning about the risks of dental problems be added to the prescribing information and patient medication guide for all buprenorphine-containing medicines that are dissolved in the mouth. The warning must also include strategies to maintain oral health while undergoing treatment. It added that prescribers should refer patients to dental services and encourage regular dental checkups while these medications are being taken.
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