ASAM Joins Other Stakeholders in Call for FDA to Retract Recent Buprenorphine Drug Safety Communication

ASAM and ten other health professional associations have called for the FDA to immediately and fully retract its buprenorphine Drug Safety Communication of January 12, 2022. In their letter, the signatories maintain that the communication is based on “flawed analysis.”

Buprenorphine and methadone are the gold standard for treating opioid use disorder (OUD), and are heavily underutilized, even though they reduce mortality for OUD by over 50%. Over one million Americans have died from opioid overdoses between 1999 and present.

The FDA based its communication on 305 cases of dental problems since 2002 when buprenorphine was first approved to treat OUD. Nearly two and a half million Americans took buprenorphine in 2019, however, and many more over the past twenty years. More than 40% of Americans have experienced dental pain in the past year. At this rate, nearly one million people who take buprenorphine would be expected to experience dental pain – 305 cases are 0.032% of nearly one million.

“In this epidemiologic circumstance,” the letter states, “it is not possible to conclude a causal relationship between exposure to a medication and dental pain when there is such a small proportion compared to the base rate.”

The FDA has not issued Drug Safety Communications for hundreds of other medications that may affect dentition by causing somewhat less saliva production. The FDA’s letter could exacerbate patients’ ambivalence to take buprenorphine that already exists due to stigma, and furthermore, many Americans do not have access to quality dental care they can afford.