FDA Warns Orally Dissolved Buprenorphine Tablets and Films Linked to Serious Dental Damage

The FDA has issued a warning that patients who are administered buprenorphine orally disintegrating tablets or films may be at a higher risk of serious dental damage when the medication disintegrates in the mouth.

By Theresa Ahearn

The Food and Drug Administration (FDA) has issued a notice to patients and physicians that transmucosal buprenorphine products taken orally may put patients at an increased risk of dental decay, infections, cavities, and possibly tooth loss.

According to the FDA, buprenorphine can be a highly effective medicine for opioid use disorder (OUD), and some forms can be used to treat moderate to severe pain. The benefits of utilizing buprenorphine drugs may significantly outweigh the risks for patients suffering from opioid addiction, and therefore doctors should carefully weigh the advantages and drawbacks before administering it. Nonetheless, adverse effects to transmucosal buprenorphine usage can be severe, and persons with no history of dental disease may be affected. Thus, the FDA is mandating a new warning to be included on prescribing paperwork and other documentation to advise patients and clinicians about the risks to dental health.

Dental Problems Associated with Buprenorphine

Orally dissolving buprenorphine has been on the market since 2002, with a film form approved by the FDA in 2015. Since the tablets were approved, the FDA has recognized 305 cases of oral damage associated with the dissolvable tablets and films. Typically, buprenorphine is administered as an under-the-tongue combination buprenorphine-naloxone oral tablet or as a film to be inserted inside the cheek. Though the FDA was unable to determine how likely it is for a person taking transmucosal buprenorphine to experience complications; they classified 42 percent of the adverse reactions as severe, and 26 of those were with patients who had no history of dental disease. Considering the findings, those who are prescribing transmucosal buprenorphine should conduct a thorough evaluation of a patient’s oral health history and refer them to a dentist for regular checkups while they are being treated.

Guidance for Dentists and Prescribers

Dentists who treat patients on transmucosal buprenorphine should perform a baseline dental evaluation and caries risk assessment, collaborate with the patient to develop a preventative strategy and recommend regular dental checkups. Doctors should also ask patients to read the Medication Guide specific for their prescription to familiarize themselves with risks and learn other essential information about this particular drug. Furthermore, patients should be informed by their prescribing physician about the potential risks to their dental health including tooth loss and decay. Patients should be educated on the benefits of maintaining good oral hygiene while using this medication and the importance of regularly visiting a dentist who can closely monitor for symptoms. Additionally, healthcare providers should inform patients of steps they can take to reduce their chance of developing an adverse reaction. The FDA recommends that after taking the medication, patients should be instructed to carefully rinse out their mouth with water and avoid brushing their teeth for at least 1 hour after the medication has dissolved.

Advice for Patients

Patients using buprenorphine are recommended to continue taking their medication as prescribed, but they should make sure they've notified their health care practitioner if they have a history of dental issues, such as cavities or gum disease. All patients taking this medication should keep in close contact with their dentist and shouldn't hesitate to notify their health care provider if they notice any oral complications. Patients prescribed this medication should be encouraged to inform their health care provider of all medications they take and any history of dental issues, including inflammation, cavities, or gum disease.

The FDA advises healthcare providers and patients to report any adverse side effects related to the use of these drugs to the FDA's MedWatch Safety Information and Adverse Event Reporting website.

Author: Theresa Ahearn is a freelance writer, currently residing in Oak Ridge, Tennessee. She received her Bachelor of Arts from the New York Institute of Technology and Master of Science from Central Connecticut State University. When not writing she can be found fishing or traveling someplace new.

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