The Food and Drug Administration (FDA) recently issued a warning concerning the risk of dental problems resulting from medications used to treat opioid addiction and pain. The warning concerns oral buprenorphine medications that are placed against the inside of the cheek or dissolved under the tongue. The use of this treatment has been reported to cause tooth decay, infection, and even tooth loss in patients – even those with no history of dental issues.
The FDA originally approved buprenorphine treatment for opioid use disorder (OUD) as tablets in 2002 and then as a film in 2015. The warning applies to buprenorphine products as a single ingredient (used to treat pain) and in combination with naloxone under the brand names Belbuca®, Bunavail®, Cassipa®, Suboxone®, Subutex®, and Zubsolv® or as their generic equivalents. Currently, other forms of buprenorphine have not been identified by the FDA as increasing risk of dental health concerns.
The FDA warning was a result of dental adverse events reported through the FDA Adverse Event Reporting System (FAERS) database and the medical literature. The FDA recommends that one should not suddenly stop taking buprenorphine medication without talking to your health care professional due to risk of withdrawal symptoms and relapse to opioid use or misuse for those taking it for OUD.
Moreover, one should take their buprenorphine medication and swish a large sip of water around their mouth after the medication is completely dissolved and then wait one hour prior to brushing your teeth. It is also important to maintain regular dental visits and inform the dentist when taking or when starting these medications. One should notify their healthcare provider and seek dental evaluation if they experience problems, and can contact the FDA MedWatch Program to track safety issues concerning this medication or any other medications.
Even though some of these problems have been significant, it is important to note that the benefits to taking buprenorphine clearly outweigh the risks and the medication remains a very important tool to treating OUD. In regard to the workers’ compensation industry, there may be an increased expense to clients associated with potential additional dental costs, especially in those taking Belbuca® products for pain. Buprenorphine products represent a small number of active prescriptions for our injured workers, but they remain a meaningful intervention in the recovery process for many. Mitchell Pharmacy Solutions will continue to monitor and provide any relevant updates to ongoing issues regarding buprenorphine dental risks and the effects they may have on the treatment of injured workers.
For more information, please read the FDA Drug Safety Communication .