- Tooth decay
- Tooth loss (tooth extraction)
- Tooth fractures, cracked teeth
- Oral surgery
- Tongue injuries
- Gum injuries
The 2022 FDA notice and article that raised concerns.
In January 2022, the FDA warned about dental problems with Soboxone (buprenorphine medicines dissolved in the mouth to treat opioid use disorder nd pain). This was FDA’s second notice about this problem. The first was a drug safety notice earlier that month. FDA wrote then, “The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. 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. 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.
In late 2022, authors wrote about the association between sublingual buprenorphine-naloxone exposure and dental disease. Specifically, their “study found an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone.”
FDA’s 2022 Recommendations
Continue taking your buprenorphine medicine as prescribed; do not suddenly stop taking it without first talking to your healthcare professional, as it could lead to serious consequences. Suddenly stopping these medicines could cause you to become sick with withdrawal symptoms because your body has become used to the buprenorphine medicine or to relapse to opioid misuse that could result in overdose and death.
Patients using buprenorphine medicines dissolved in the mouth should take extra steps to help lessen the risk of serious dental problems. After the medicine is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. You should wait at least 1 hour before brushing your teeth to avoid damage to your teeth and give your mouth a chance to return to its natural state.
Inform your healthcare professional if you have a history of tooth problems, including cavities. Schedule a dentist visit soon after starting this medicine. Inform your dentist that you are taking buprenorphine, and schedule regular dental checkups while taking this medicine. Your dentist can customize a tooth decay prevention plan for you. Notify both your health care professional and your dentist immediately if you experience any problems with your teeth or gums.
Healthcare professionals should be aware the benefits of buprenorphine medicines clearly outweigh the risks and are an important tool to treat OUD. When combined with counseling and other behavioral therapies, this comprehensive medication-assisted treatment approach is often the most effective way for treating OUD and can help sustain recovery and prevent or reduce opioid overdose.
Ask patients about their oral health history prior to prescribing treatment with a transmucosal buprenorphine medicine. These serious dental problems have been reported even in patients with no history of dental issues, so refer them to a dentist as soon as possible after starting transmucosal buprenorphine. Counsel patients about the potential for dental problems and the importance of taking extra steps after the medicine has completely dissolved, including to gently rinse their teeth and gums with water and then swallow. Patients should be advised to wait at least 1 hour before brushing their teeth. Dentists treating someone taking a transmucosal buprenorphine product should perform a baseline dental evaluation and caries risk assessment, establish a dental caries preventive plan, and encourage regular dental checkups.
FTC Sued Suboxone’s Manufacturer for Price-Related Issues
The lawsuit alleged the company prevented consumers from accessing less expensive generic versions. FTC settled the case for $60,000,000. Those who had “a prescription for Suboxone® film in the United States between March 1, 2013 and February 28, 2019,” might have been eligible for a payment. The deadline was the end of 2020.
The Judicial Panel on Multi-District Litigation coordinated this matter in the Northern District of Ohio before Judge Calabrese early this year. KBA’s criteria:
- Use of Suboxone dissolvable strips for at least six months prior to dental issues;
- Has at least two of the following: tooth loss (multiple losses can satisfy criteria alone), tooth fractures, tooth decay, oral surgeries, tongue injuries, gum injuries;
- No history of similar dental issues before Suboxone use;
- Regular dental care before Suboxone use; and
- Some use/and some dental injury/treatment after 2010, or the client has medical records for both if before 2010.
Discuss Suboxone Claims with a Dedicated Attorney
Do not rely on this information for medical purposes. Do not stop taking any medication based on this; speak with a licensed healthcare professional or your treaters. If you want to speak with an attorney about potential claims, please contact us today.