FDA Warns of Dangers Associated with Buprenorphine Medicines: Here's What You Need to Know

The U.S. Food and Drug Administration (FDA) has issued a critical warning regarding the use of buprenorphine-based medications, including Suboxone®, that are dissolved in the mouth. These medications, commonly prescribed to treat opioid use disorder (OUD) and pain, have been linked to serious dental problems, including enamel erosion, tooth decay, cavities, oral infections, and tooth loss. This blog aims to provide essential information about these risks, the FDA's recommendations, and what steps you can take if you or a loved one has been affected.

Background on Buprenorphine

Buprenorphine-based medications, including Suboxone®, have been crucial tools in the fight against opioid addiction and pain since 2002. Initially available as a tablet administered under the tongue, the medication has been expanded, alone and in combination with other medications, to include a film version that is placed inside the cheek or under the tongue, approved since 2015 for pain management. Both forms are designed to dissolve in the mouth, allowing for the slow release of the medication into the bloodstream.

Buprenorphine is highly effective in treating OUD by reducing cravings and withdrawal symptoms, which can help sustain recovery and prevent relapse. However, the recent findings by the FDA reveal that these benefits can come with a significant risk to oral health.

Associated Dental Problems

The FDA's warning is based on reports of severe dental issues in patients using buprenorphine medicines dissolved in the mouth. Alarmingly, these problems have occurred even in patients who had no prior history of dental issues. The dental complications reported include:

Tooth Decay: Patients have experienced rapid and severe tooth decay, which has led to extensive damage requiring major dental work or extractions.

Cavities: The development of cavities has been widespread among users, often progressing quickly and leading to further oral health issues.

Oral Infections: Bacterial infections in the gums and teeth have been reported, likely due to the damage caused by the medication's interaction with the oral environment.

Tooth Loss: In extreme cases, the damage has been so severe that patients have lost teeth.

The exact mechanism behind these dental problems is not entirely clear, but it is believed that the acidity and sugar content in the buprenorphine formulation, combined with the extended contact time with the teeth and gums, may contribute to enamel erosion and the deterioration of dental health.

FDA Recommendations for Patients

Despite these risks, the FDA continues to emphasize that the benefits of buprenorphine for treating OUD and pain outweigh the potential for dental problems. However, they have issued specific recommendations to help patients mitigate these risks:

1. Continue Taking Buprenorphine as Prescribed: Patients should not abruptly stop taking their medication without consulting their healthcare provider. Suddenly discontinuing buprenorphine can lead to severe withdrawal symptoms and an increased risk of relapse, which could result in overdose and death.
2. Practice Good Oral Hygiene: After the buprenorphine has completely dissolved, patients should take a large sip of water, swish it gently around their teeth and gums, and swallow. This helps to wash away any remaining residue of the medication. Importantly, patients are advised to wait at least one hour before brushing their teeth to avoid damaging their enamel, as brushing too soon can exacerbate the risk of decay.
3. Consult with a Dentist: Patients using buprenorphine should schedule a dentist appointment soon after starting the medication. Informing the dentist about buprenorphine use is crucial so they can tailor a tooth decay prevention plan. Regular dental checkups are also recommended to monitor and address any emerging issues promptly.
4. Report Any Dental Problems: If you experience any issues with your teeth or gums while taking buprenorphine, notify your healthcare provider and dentist immediately. Early intervention can prevent more severe complications.

Legal Implications for Affected Patients

If you or a loved one has suffered from dental problems as a result of taking Suboxone®, a specific medication comprised of buprenorphine and naloxone, administered as a film placed inside the cheek or under the tongue, you may have legal recourse. The FDA's warning highlights that these issues have occurred even in patients with no previous dental history, suggesting that the risks associated with buprenorphine may not have been fully disclosed or understood when the medication was prescribed.

Potential legal claims could include:

Failure to Warn: Pharmaceutical companies have a duty to adequately warn patients and healthcare providers about the risks associated with their products. If the risks of dental damage were not clearly communicated, patients may have grounds for a failure to warn claim.

Product Liability: If the formulation of buprenorphine is found to be inherently dangerous to dental health, patients may pursue product liability claims against the manufacturers.

What to Do Next

If you believe you have been harmed by buprenorphine use, it is important to take the following steps:

1. Document Your Dental Issues: Keep detailed records of your dental problems, including any treatments you have undergone, and how these issues have affected your quality of life.
2. Seek Legal Advice: Consult with an attorney who specializes in pharmaceutical litigation or personal injury. They can help you assess your case and determine the best course of action.
3. Stay Informed: Keep up with any new developments regarding buprenorphine and the associated risks. The legal landscape surrounding this issue may evolve as more information becomes available and as more patients come forward.

Call Kershaw Talley Barlow to Learn More About Your Legal Options

The FDA's warning about the dental risks associated with buprenorphine-based medications is a critical reminder that even life-saving medications can have serious side effects and adverse events. While buprenorphine-based medications remain essential tools in combating opioid addiction and pain, patients should be aware of the potential risks to their oral health and take steps to protect themselves.

For those who have suffered harm, understanding your legal rights is the first step toward seeking justice and compensation. Contact our skilled Suboxone® attorneys[MOU1] at Kershaw Talley Barlow today to learn more about your options. We represent individuals who have been affected by unsafe and defective drugs, providing our clients with an array of talented and dedicated attorneys and experts ready to fight for their rights.