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FDA advises on medication-assisted treatment for individuals taking depressants

Scott Gottlieb

The FDA today issued a Drug Safety Communication advising that buprenorphine and methadone should not be withheld from individuals receiving benzodiazepines or other medications that depress the central nervous system.

The communication also stated that although combined use of these medications increases risk for serious side effects, harm caused by untreated opioid addiction outweighs these risks.

“To underscore the importance of appropriately utilizing [medication-assisted treatment (MAT)] products, the FDA is requiring changes to MAT drug labels to help decrease the risks of combining these drugs, while taking steps to address situations where the MAT drugs methadone or buprenorphine might be co-administered with benzodiazepines,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “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.”

The FDA requires the addition of this information to buprenorphine and methadone drug labels, along with recommendations for minimizing use of medication-assisted treatment (MAT) drugs and benzodiazepines together.

These changes follow the FDA’s warning last year regarding risks associated with using opioid painkillers or prescription opioid cough products and benzodiazepines at the same time.

“At that time, more consideration was needed regarding the combined use of these MAT drugs and benzodiazepines or other [central nervous system (CNS)] depressants due to the unique medical needs and benefit-risk considerations for this specific patient population,” Gottlieb said in the release. “As a result of that consideration, the FDA’s new advisory that we’re issuing today asks health care providers and patients to be aware of these risks. But at the same time, the agency is also reinforcing that MAT should not necessarily be denied to patients taking these other medications.”

The FDA recommended health care providers take precautions and develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or CNS depressants. This entails:

• Educating patients about serious risks associated with combined use, even when used as prescribed;
• Developing strategies to manage use of prescribed or illicit benzodiazepines or CNS depressants when beginning MAT;
• Tapering benzodiazepine or CNS depressant to discontinuation if possible;
• Confirming diagnosis if an individual is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions;

• Recognizing that individuals may require MAT indefinitely, and use should continue as long as they are benefitting from treatment;
• Coordinating care to ensure all prescribers are aware of buprenorphine or methadone treatment; and
• Monitoring patients for illicit drug use, including urine or blood screenings.

“Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the FDA’s highest priorities,” Gottlieb said in the release. “We must do everything possible to address the staggering human toll caused by opioid use disorders, and ensuring patients receive proper treatment for both addiction and coexisting mental health conditions is a critical step in that effort.”