Dental Problems Have Been Reported with Medicines Containing Buprenorphine that are Dissolved in the Mouth
Dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth (e.g., dissolving tablets and films). The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Reports indicate that one or more teeth may be affected and tooth extraction/removal is the most common treatment.
Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.
Recommendations for Patients
- Schedule an appointment with your dentist soon after starting this medicine and inform your dentist that you are taking it. Your dentist can customize a tooth decay prevention plan for you. Visit the dentist for regular checkups while taking this medicine.
- Notify your health care professionals immediately and seek dental treatment if you experience any problems with your teeth or gums while taking buprenorphine medicines that are dissolved in the mouth. If you are starting this medicine, tell your health care professional if you have any tooth problems, including a history of cavities.
- When taking your buprenorphine medicine and after it is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. Wait at least 1 hour before brushing your teeth.
- Do not suddenly stop taking your buprenorphine medicine without first talking to your health care professional as it could lead to serious consequences, including relapse to opioid misuse or abuse that could result in overdose and death. You could also become sick with withdrawal symptoms because your body has become used to the buprenorphine medicine.
Recommendations for Healthcare Providers
- Screen patients for oral disease and ask about their oral health history prior to beginning therapy with a transmucosal buprenorphine medicine.
- Counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of this medicine and it is important to visit their dentist to closely monitor their teeth.
- Refer patients to a dentist as soon as possible after starting transmucosal buprenorphine for a baseline dental evaluation, dental caries risk assessment and preventive plan, and encourage them to have regular dental checkups while taking the medicine.
- Educate patients on strategies to maintain or improve oral health while being treated with transmucosal buprenorphine medicines. Counsel them that after the medicine has completely dissolved in the oral mucosa, to gently rinse their teeth and gums with water and then swallow. Patients should wait at least 1 hour before brushing their teeth after using the medicine, which will allow the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.
- Provide medication education with each prescription, explaining the safety risks and provide other important information as needed.
- Counsel patients they should use their buprenorphine only as prescribed and should not stop it because they can experience serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.
The complete Drug Safety Communication can be viewed on the FDA website .
Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).
Instructions for reporting can be found online at the NPTC Pharmacovigilance website.