Medical Technology

Oral Buprenorphine is linked to severe tooth Decay, FDA Warns

Orally dissolving drugs that contain buprenorphine can cause severe dental problems, including complete teeth loss. The US Food and Drug Administration (FDA) warns in safety communication.

These medications are used to treat pain and to treat opioid use disorder (OUD). The oral side effects are tooth decay/cavities, tooth abscesses/infection, tooth erosion fillings falling off, and sometimes, complete tooth loss.

Multiple cases have been reported in patients who had no previous history of dental problems.

The FDA is adding a warning about the risk of dental problems to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth.

The FDA emphasizes that buprenorphine continues to be “an important treatment option for OUD and pain, and the advantages of these medicines far outweigh the risks.”

More than 300 Cases

Buprenorphine has been approved as a tablet for sublingual use in 2002. It was also approved as a film to be in the cheek to relieve pain in 2015. Both delivery methods have been linked to dental problems.

The FDA has reported 305 dental issues related to buprenorphine orally dissolving, including 131 that are considered serious, since buprenorphine’s approval.

The FDA believes that there could be additional instances. These are the only reported cases that have been published in medical journals or reported to FDA.

The average age of patients who developed dental problems while taking buprenorphine is 42 years old, however patients as young as 18 years old also experienced problems.

Patients who took OUD medications most often experienced issues. However, 28 instances of dental problems were reported by patients who used OUD to treat pain.

In 26 cases patients, there was no prior experience of dental problems. Certain patients developed dental problems immediately after treatment began. The median time required to determine the cause was around 2 years.

113 of the 305 cases were said to have involved two or more teeth.

The most commonly used treatment was tooth removal/removal. This was documented in 71 cases. Other cases required root canals as well as dental surgery, in addition to other procedures such as crowns and implant placements.

Recommendations

The FDA says healthcare providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients are advised to continue taking buprenorphine according to the prescription. It is not recommended to stop abruptly without talking to their physician. This could result in serious consequences including the possibility of relapse, misuse, abuse overdose, or even death.

Patients are also advised to take additional steps to reduce the chance of developing serious dental issues.

Patients should also be informed about strategies to improve or maintain oral health while taking transmucosal buprenorphine medicines.

Once the medicine has completely dissolved in the oral mucosa of the patient, gently clean their teeth with water , and then swallow. After taking the medicine, patients should wait at least an hour before brushing their teeth.

The FDA recommends that patients drink an ample amount of water following the medicine has completely dissolving. Then, they should swish the water around their teeth and gums and wait at least one hour before brushing their teeth. This allows the mouth to gradually return to oral homeostasis and prevent any mechanical damage that could result from brushing.

The FDA suggests that patients inform their doctor of any previous tooth issues, including cavities, as well as scheduling a visit to the dentist shortly after they start taking the medication.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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