Opioid Use Disorder

Hailey Mook, PharmD

In early January 2022, FDA released a Drug Safety Communication surrounding dental problems following use of buccal and sublingual buprenorphine products for the treatment of pain and opioid use disorder.

The warning comes after reports of dental problems, including tooth decay, cavities, oral infections, and loss of teeth, in patients using buccal and sublingual buprenorphine, regardless of their dental history.

Buprenorphine comes in a variety of formulations, including Subutex (sublingual tablets); Suboxone (combination product with naloxone available in both sublingual films and sublingual tablets); Sublocade (extended-release subcutaneous injection); Belbuca (buccal film); and Butrans (transdermal patch).

Initially approved for the treatment of opioid use disorder in 2002 as a sublingual tablet, buprenorphine buccal films were later approved for the treatment of pain.

Butrans (buprenorphine transdermal patches) are currently only FDA-approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate.

Opioid agonist medications, including buprenorphine, can reduce saliva production in the mouth, according to FDA. Reduced saliva production can lead to the dental problems mentioned previously. While transdermal or injectable formulations have a risk of dry mouth, these formulations are not mentioned in the FDA statement.

FDA said they will be requiring a new warning on the risk of dental problems to be added to both the prescribing information and patient medication guides for all oral dissolvable sublingual and buccal buprenorphine containing products.

This warning is not required for injectable or patch buprenorphine formulations.

Patient counseling

With this new warning, FDA recommends prescribers, dentists, and pharmacists do their part in educating patients on their oral health.

Prescribers and pharmacists should be prepared to ask patients about their oral health history, including the last time a patient was seen by a dentist. Also, pharmacists may also have recommendations for dentists to whom they can refer patients.

In addition to informing patients on proper oral hygiene techniques, pharmacists should counsel patients to gently rinse their teeth and gums with water, then swallow once the buccal or sublingual buprenorphine product has completely dissolved. They also need to wait at least one hour after taking their buprenorphine dose before they brush their teeth.

Some steps that patients can take for optimum oral health and to reduce the risk of tooth decay include twice daily brushing, regular flossing, drinking water throughout the day, and routine dental checkups.

The Substance Abuse and Mental Health Services Association said they “[urge] patients and providers to weigh the lifesaving benefits of buprenorphine with this identified risk in making decisions about starting and ongoing use of buprenorphine.”

FDA also states that when combined with counseling and other behavioral therapies, buprenorphine containing products are commonly the most effective way to treat opioid use disorder. ■