Buprenorphine Side Effects Can Cause Tooth Decay, Other Dental Problems, FDA Warns

The opioid addiction treatment is given as a pill or tab that dissolves under the tongue or inside of the cheek.

Federal drug regulators are warning about potential side effects of buprenorphine, indicating that the drug often prescribed to combat opioid addiction may cause tooth decay, infection, and other dental issues.

Medications containing buprenorphine designed to dissolve in the mouth can lead to dental problems, according to a drug safety communication issued by the FDA on January 12. Users with no history of dental issues have reported experiencing tooth decay, cavities, oral infections and loss of teeth, the agency warns.

Buprenorphine was first approved in 2002, as a tablet to be taken under the tongue to treat opioid addiction. In 2015, buprenorphine was approved as a film to be placed inside the cheek to treat pain. Other studies have linked buprenorphine as the best drug to treat neonatal abstinence, among infants born addicted to narcotic painkillers. However, the FDA indicates there have been more than 300 cases of tooth decay and dental problems reported among patients, most commonly involving tooth decay among users in their 40s, but dental problems have also been seen among those as young as 18 years old. Some dental problems from buprenorphine occurred as soon as two weeks after beginning treatment.

While the FDA indicates it believes the benefits of buprenorphine still outweigh the risks, the agency is requiring a new warning be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth.

Medications affected by the warning include Zubsolv, manufactured by Orexo, and Suboclade manufactured by Indivior. They are tablets and films which dissolve under the tongue or placed against the inside of the cheek.

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For patients taking buprenorphine drugs affected by the warning, the FDA recommends continuing to take the medication as prescribed and not stopping the medication until you speak to your doctor first. Suddenly stopping the treatment could lead to serious consequences, including withdrawal symptoms or opioid relapse, which can result in an overdose and death.

Patients using the medication to treat opioid use disorder can take extra steps to reduce the risk of dental problems, the FDA indicates.

The agency recommends patients take a large sip of water, swish it gently and swallow once the medication is completely dissolved in the mouth. They should then wait at least one hour before brushing their teeth to avoid damage and to give their mouth a chance to return to its natural state, the FDA warning indicates.

The FDA also recommends patients inform their doctor if they have a history of tooth problems, including cavities, when starting this medication. They should also schedule a visit with their dentist soon after starting to use this drug and inform their dentist they are taking buprenorphine. Patients taking the drug should also make sure to have regular dental checkups while taking buprenorphine and to notify their doctor and dentist immediately if they experience problems with their teeth and gums.

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