August 31, 2016
FDA Requiring Boxed Warnings on Concomitant Use of Prescription Opioids with Benzodiazepines
As part of the federal government’s efforts to address the opioid epidemic, the U.S. Food and Drug Administration (FDA) issued a drug safety communication that the Agency is adding Boxed Warnings to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. For health care professionals, the drug safety communication states:
"Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol."
The entire drug safety communication is available here, and a sample Boxed Warning for opioid analgesics is available here. To learn about ASA’s efforts to reduce the misuse and abuse of prescription drugs, visit the ASA pain medicine website.