17 / 01 / 2022
Orally dissolving medications containing buprenorphine are linked to severe dental problems, FDA warns

Buprenorphine was approved by the US Food and Drug Administration (FDA) in 2002 to treat opioid use disorder and pain.

Since then, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious. The oral side effects of these medications include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss. Multiple cases have been reported even in patients with no history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

At the same time, the FDA emphasizes the significant benefits of this drug and advises healthcare professionals to provide additional advice to patients who need it:

  • Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their healthcare provider as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.
  • Patients should be aware of the importance of visiting their dentist to closely monitor their teeth.
  • Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines. After the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

Source: Orally Dissolving Buprenorphine Tied to Severe Tooth Decay, FDA Warns