FDA flags risk of dental issues from use of opioid addiction drug buprenorphine

Signage is seen outside of FDA headquarters in White Oak, Maryland
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Jan 12 (Reuters) - The U.S. health regulator on Wednesday warned patients and prescribers about the risk of potential dental problems arising from the use of buprenorphine medicines to treat opioid addiction and pain.

The Food and Drug Administration said the opioid addiction treatment has been reported to cause tooth decay, infection, and, in some cases, total tooth loss in patients with no history of dental issues. (https://bit.ly/3fiJEj8)

The buprenorphine medicines that are associated with dental problems are tablets dissolved under the tongue and films placed against the inside of the cheek.

The FDA, which approved buprenorphine as a tablet in 2002 and as a film in 2015, said patients may lessen their risk by taking preventative measures, including waiting for at least one hour before brushing their teeth after use of the product.

The regulator's approved buprenorphine products include Orexo's Zubsolv, Indivior's (INDV.L) Suboclade, among others.

The benefits of buprenorphine medicines for opioid use disorder and pain clearly outweigh the risks, and are important tools in treating these conditions, the FDA said.

Reporting by Leroy Leo; Editing by Shailesh Kuber

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