FDA Issues Warning About Dental Risk With Transmucosal Buprenorphine

The U.S. Food and Drug Administration (FDA) has issued aDrug Safety Communication about dental problems associated with the use of buprenorphine products that dissolve in the mouth (transmucosal) and is requiring that a new warning about the risk of dental problems be added to the prescribing information and patient medication guides for these products. The dental problems include tooth decay, cavities, dental abscesses/infection, tooth erosion, or tooth loss.The warnings come after an FDA review of cases reported to the agency or published in the medical literature revealed 305 cases of dental problems, 131 of them classified as serious, among patients who take transmucosal buprenorphine. Most of the dental problems occurred in patients who used the medication to treat opioid use disorder (OUD), although 28 cases occurred in patients who used the medication to treat pain. The most common treatment for these dental problems was tooth extraction or removal, reported in 71 cases. Other cases involved root canals, dental surgery, or other procedures such as crowns and implants.“It would be useful to learn more about these reports and understand what proportion of total people using these specific formulations may be affected,” said Smita Das, M.D., Ph.D., M.P.H., chair of APA’s Council on Addiction Psychiatry. She noted that 305 is a relatively low number of cases g iven the number of people who take transmucosal buprenorphine among the approximately 1.7 million people who...
Source: Psychiatr News - Category: Psychiatry Tags: buprenorphine dental problems Drug Safety Communication FDA opioid use disorder oral health public health emergency samhsa Smita Das transmucosal Source Type: research