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FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain

Audience: Health Care Professionals, Patients, Caregivers

What safety concern is FDA announcing?

The U.S. Food and Drug Administration (FDA) is 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. 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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Source: FDA

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