FDA warns about dental problems with buprenorphine

Iveta Ramonaite, Dental Tribune International

Tue. 25 January 2022

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SILVER SPRING, Md., US: The US Food and Drug Administration (FDA) has recently announced that medicines containing buprenorphine that are dissolved under the tongue or placed against the inside of the cheek may worsen a patient’s oral health and cause dental problems such as dental caries, cavities, oral infections and even loss of teeth. However, the FDA says that buprenorphine is highly valued for the treatment of opioid use disorder (OUD) and pain and that the benefits of the medicine outweigh the risks.

Buprenorphine is a drug that is often used to treat dependence on opioids by reducing OUD withdrawal symptoms and the craving to use opioids. Combined with counselling and other behavioural therapies, buprenorphine is considered one of the most effective methods to treat OUD. It can help patients sustain recovery from addiction as well as reduce or even prevent opioid overdose, thus improving patient survival and decreasing opioid use, which may help patients gain and maintain employment, the US Substance Abuse and Mental Health Services Administration states.

The medicine has also been widely used for pain management, for which it was approved in 2015. The use of buprenorphine to treat OUD was approved in 2002.

Buprenorphine is usually placed under the tongue or in the cheek. It can also be delivered as a skin patch or injection, but these routes of administration have not been identified as a concern for dental health by the FDA, contrary to orally dissolving buprenorphine.

Buprenorphine and dental problems

Since its approval, the FDA has identified 305 cases of dental problems when buprenorphine medicines have been dissolved in the mouth, of which 131 were classified as serious. Most oral conditions were identified in patients who use buprenorphine to treat OUD, and the data shows that the medicine affects people of different ages.

When assessing patients’ dental records, it was found that, out of the 305 cases, 26 patients had had no prior history of dental problems, and 113 mentioned that two or more teeth had been affected after using buprenorphine. The patients reported noticing oral health problems from two weeks to some years after initial treatment.

According to the FDA, a large number of adverse drug effects on teeth were reported by healthcare professionals. The most common treatment prescribed for treating buprenorphine-related dental problems was tooth extraction or removal, which was reported in 71 cases. Other cases required root canals, dental surgery and procedures such as crown and implant placement.

What healthcare professionals should do

The FDA is currently requiring regulatory authorities to add a new warning about the risk of using buprenorphine-containing medicines dissolved in the mouth to the prescribing information and the patient medication guide.

In light of the findings, the FDA said that healthcare professionals should ask patients about their oral health history before prescribing treatment with a transmucosal buprenorphine medicine and should refer them to a dentist soon after initiating the treatment. Additionally, it advised healthcare professionals to inform patients about the adverse effects that the drug might have on oral health and to instruct them to take extra precautions after the medicine has completely dissolved in the mouth, including gently rinsing teeth and gingivae with water before swallowing it. Additionally, after taking the medicine, patients ought to wait a minimum of 1 hour before brushing their teeth.

Finally, the FDA recommended that dentists who treat patients taking a transmucosal buprenorphine product should perform a baseline dental evaluation and caries risk assessment, establish a dental caries preventive plan and talk to patients about the importance of regular dental check-ups.

Opioid prescription in dentistry

In a study reported by Dental Tribune International (DTI), researchers from the University of Illinois at Chicago found that US dentists prescribe 37 times more opioids than English dentists do and that US dentists prescribe a larger variety of opioids. In a different study, researchers from the University of Pittsburgh School of Medicine reported that over half of opioid prescriptions issued by dentists exceed the three-day supply recommended by the Centers for Disease Control and Prevention for acute dental pain management. Additionally, the findings showed that 29% of dental patients received more potent opioids than needed for expected postoperative pain.

As Dr David Hamlin, a regional dental director at the global health service and insurance company Cigna, told DTI, dentists play a crucial role in preventing the misuse of opioids and addiction to them, especially among teenagers and young adults. The company advocates safer alternative strategies for dental pain management, including the use of ibuprofen, and recommends that dental professionals continuously update their knowledge on current standards of care through evidence-based research on pain management.