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  1. Drug Safety and Availability

FDA warns about risks of dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

[1/12/2022] The U.S. Food and Drug Administration is warning patients and prescribers about the potential for dental problems associated with buprenorphine medicines  dissolved in the mouth to treat opioid use disorder (OUD) and pain. 

Dental problems (including tooth decay, cavities, dental abscesses/infection, tooth erosion, and, in some cases, total tooth loss), have been reported even in patients with no history of dental issues. 

Buprenorphine is an opioid that works by changing the way the brain and nervous system respond to pain. Buprenorphine was approved in 2002 as a tablet to be administered under the tongue to treat OUD. In 2015, buprenorphine was approved as a film to be placed inside the cheek to treat pain. The buprenorphine medicines that are associated with dental problems are tablets and films dissolved under the tongue or placed against the inside of the cheek. These medicines are available as single-ingredient products and also in combination with naloxone. There are also buprenorphine products for pain and OUD delivered by other routes such as a skin patch and injection, but FDA has not identified a concern for dental health related to these other forms.  

Regular adherence to medication assisted treatment with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. The comprehensive approach of buprenorphine medicine combined with counseling and other behavioral therapies is often one of the most effective ways to treat OUD. This approach has been shown to sustain recovery, prevent or reduce opioid overdose, improve patient survival, and allow patients the ability to live a self-directed life. FDA cannot determine how likely it is that a patient will experience dental problems when taking buprenorphine medicines that dissolve in the mouth; however, the benefits of buprenorphine medicines for OUD and pain clearly outweigh the risks, and are important tools in treating these conditions.

Patients may lessen their risk of dental problems by taking certain preventative measures. After the product is completely dissolved, patients should take a large sip of water, swish it gently around their teeth and gums, and swallow, waiting for at least one hour before brushing their teeth after use of the product to avoid damage to the teeth. Patients should also visit a dentist to develop a preventative strategy, including close monitoring by the dentist and regular dental checkups.

FDA is taking several measures to protect public health and will require that a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide  for all buprenorphine-containing medicines that are dissolved in the mouth. Prescribers should advise patients to see a dentist soon after starting the medicine and during treatment. Patients should report to the dentist all medicines that they take, including buprenorphine. for all buprenorphine-containing medicines that are dissolved in the mouth. Prescribers should advise patients to see a dentist soon after starting the medicine and during treatment. Patients should report to the dentist all medicines that they take, including buprenorphine.

FDA also encourages patients and prescribers to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:
•    Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
•    Download and complete the form, then submit it via fax at 1-800-FDA-0178.
 

 
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