FDA warns about dental problems with sublingual buprenorphine to treat opioid use disorder and pain
The U.S. Food and Drug Administration (FDA) has issued warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The 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.
There are also buprenorphine products for pain and opioid use disorder delivered by other routes such as a skin patch and injection, but FDA has not identified a concern for dental health related to these other forms.
Buprenorphine was first approved in 2002 as a tablet to be administered under the tongue to treat OUD. In 2015, buprenorphine was approved as a film to be placed inside the cheek to treat pain.
Buprenorphine works by changing the way the brain and nervous system respond to pain. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making misuse of them less appealing. The benefits of buprenorphine medicines clearly outweigh the risks, particularly in the treatment of OUD.
Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.
Regular adherence to buprenorphine to treat OUD reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat OUD. This approach, called medication-assisted treatment (MAT), is tailored to meet each patient's needs and can help sustain recovery and prevent or reduce opioid overdose. According to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), MAT has been shown to be effective in improving patient survival, decreasing opioid use, and allowing patients to live a self-directed life, including the ability to gain and maintain employment.
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