The practice of ending treatment if patients test positive for benzodiazepines was discouraged in no uncertain terms by the Food and Drug Administration (FDA) last fall. Then, FDA commissioner Scott Gottlieb, MD, issued a powerful twofold statement: Combining benzodiazepines and other central nervous system depressants is known to be dangerous, but kicking people out of medication-assisted treatment (MAT) is worse.
Dr. Gottlieb added that MAT “should not necessarily be denied to patients taking these other medications,” because the “dangers associated with failing to treat an opioid use disorder can outweigh the risks of co-prescribing MAT and benzodiazepines.” MAT, he said, “is one of the major pillars of the federal response to the opioid epidemic in this country.”
A Strong Supporter of MAT
Dr. Gottlieb has emerged as one of the strongest supporters of MAT in this administration. He said that “patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration,” and that “many patients with opioid use disorder might abuse other substances, or have a coexisting chronic condition, such as a mental health disorder.”
On September 20, the FDA issued a Drug Safety Communication indicating that co-administering methadone or buprenorphine with benzodiazepines “can pose serious risks, including difficulty breathing, coma, and death.” However, while the advisory asks providers to be aware of these risks, it says that it’s more important, in the case of opioid use disorders, to keep patients on their methadone or buprenorphine, than it is to stop treatment, when patients would not be under any care, and could end up overdosing.
Labeling Changes are Coming
Changes will be made in labels of methadone and buprenorphine to decrease the practice of combining these medications with CNS depressants, while acknowledging that these medications might be co-administered with benzodiazepines.
“The new labeling recommends that health care providers develop a treatment plan that closely monitors any concomitant use of these drugs, and carefully taper the use of benzodiazepines, while considering other treatment options to address mental health conditions that the benzodiazepines might have been initially prescribed to address,” said Dr. Gottlieb.
For the FDA’s Drug Safety Communication, go to https://www.fda.gov/Drugs/DrugSafety/ucm575307.htm