UNITED STATES: The U.S. Food and Drug Administration (FDA) has recently warned that dental problems had been reported with drugs containing Buprenorphine that dissolved in the mouth.
Patients using Buprenorphine, even with no history of dental issues, have been reported with dental problems, including tooth decay, oral infections, and loss of teeth.
Mouth dissolvable Buprenorphine-containing medicines are approved to treat opioid use disorder (OUD), and one product is approved to treat pain. In 2002, Buprenorphine was approved as a tablet to be administered under the tongue to treat opioid use disorder (OUD). It acts by changing how the brain and nervous system respond to pain. At proper doses, Buprenorphine also lessens the pleasurable effects of other opioids, making their misuse less appealing. They are available as single-ingredient products and in combination with naloxone.
According to the FDA database and the medical literature through December 31, 2018, 305 cases of dental adverse events were reported with transmucosal buprenorphine use. Patients with OUD may have a higher incidence of poor dental health; however, twenty-eight cases of dental problems are seen in patients using it to treat pain. Many cases showed severe dental issues in patients with no reported prior history of dental problems.
However, as per FDA, Buprenorphine is still an important treatment option for OUD and pain, and the benefits of these medicines outweigh the risks.