FDA issues guidance on MAT drugs

Saying that addressing the opioid epidemic is “my highest public health priority,” FDA Commissioner Scott Gottlieb, MD, issued a statement with new measures to promote more widespread, safe adoption of medication-assisted treatment for addiction.

The FDA issued a drug safety communication alerting providers and patients of the increased risk of serious side effects when combining MAT drugs methadone or buprenorphine with benzodiazepines, and how to address such risks while continuing to maintain patients on MAT.

“But at the same time, the agency is also reinforcing that MAT should not necessarily be denied to patients taking these other medications,” Gottlieb said in the statement. “The dangers associated with failing to treat an opioid use disorder can outweigh the risks of co-prescribing MAT and benzodiazepines. Instead, careful management of the patient and coordination of care is recommended.”

Stuart Gitlow, MD, MPH, immediate past president of the American Society of Addiction Medicine (ASAM) board of directors, says that in his personal view, this ultimately is a harm-reduction approach that has merit.

“The risk, of course, is that a combination of buprenorphine and a prescribed benzodiazepine is significant and that the individual can overdose on the two,” Gitlow says. “However, the risk is even more substantial if they’re using full agonist opiates like heroin combined with that same benzodiazepine. So essentially, by prescribing buprenorphine, you would be reducing the risk they would have on their own. The recommendation is go ahead and prescribe buprenorphine, then work with them to reduce and eliminate the benzodiazepine as opposed to waiting for the benzodiazepine to be reduced or eliminated before prescribing buprenorphine.”

The alert follows an FDA warning in 2016 on using opioid pain medications or prescription opioid cough medications and benzodiazepines simultaneously. Now, the administration is requiring MAT drug label changes to decrease the risks of combining the medications and calling on prescribers to develop a treatment plan that monitors concurrent use of the drugs while tapering the use of benzodiazepines and considering other treatment options as an alternative to the benzodiazepines.

In a separate change, the FDA recently strengthened labeling for buprenorphine to emphasize that patients may require indefinite treatment and should continue with buprenorphine for as long as it contributes to their intended treatment goals. It’s a notable position to be taken by the FDA, as some treatment providers remain hesitant to use buprenorphine for purposes beyond the detoxification of patients, believing in an abstinence-only model for recovery. Still, Gitlow says the adjustment to labeling “is consistent with standard of care.”

“That’s certainly consistent with the original tip on buprenorphine, as well as being consistent with the practice of physicians with buprenorphine for many years now,” Gitlow says. “We’ve certainly felt maintaining an individual on buprenorphine indefinitely is the most likely approach to getting a beneficial outcome for a patient with an opiate use disorder long term. ”