Buprenorphine is approved by the Food and Drug Administration (FDA) to treat opioid use disorder and severe pain. The FDA is now revising the labeling of transmucosal forms of buprenorphine to warn of an increased risk of serious dental problems, including tooth decay, cavities, oral infections, and loss of teeth, even in those with no history of dental issues. These adverse effects are not observed when the drug is administered via other routes, such as subcutaneously.

Buprenorphine is a semisynthetic opioid that functions as an opioid partial agonist; although it stimulates mu opioid receptors, it cannot create the maximal effects of full opioid agonists such as heroin, morphine, and oxycodone. Thus, buprenorphine can control opioid cravings and stop abuse without inducing withdrawal. The FDA believes the benefits of buprenorphine outweigh the risks of adverse dental effects.

The FDA based its new warning on a review of the literature and on case reports submitted to the agency. The FDA reviewed 305 cases of dental problems associated with buprenorphine. Of these, 131 described serious dental adverse effects. Most of the patients were using buprenorphine for opioid use disorder, but 28 were being treated for pain. In 26 patients, there was no history of dental problems. The adverse effects included cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion/fractures; fillings falling out; and total tooth loss. Multiple teeth were typically affected. The most common required treatment was tooth extraction; other treatments included root canal, dental surgery, and restorative procedures (such as crowns and implants). The median time to diagnosis of these adverse effects was about two years after start of buprenorphine treatment.

Nurses and NPs who care for patients prescribed transmucosal buprenorphine should complete an oral history and assessment prior to the patient beginning treatment. Patients should be informed of these potential adverse effects and encouraged to receive regular dental care. Patients can minimize their risk of dental problems by rinsing their mouth and gums with water after the drug is fully dissolved and then swallowing the water. After taking the medication, patients should wait at least one hour before toothbrushing to allow for normal oral homeostasis to return and to avoid mechanical damage from brushing. Noted adverse effects from buprenorphine should be reported to the FDA MedWatch program: http://www.accessdata.fda.gov/scripts/medwatch.

To read the full FDA Drug Safety Communication regarding buprenorphine, go to http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-pro.