FDA Issues Warning on Combined Use of Prescription Opioids, Benzodiazepines

The Food and Drug Administration today announced that it will require class-wide changes to the labels of all prescription opioid medications and benzodiazepines in an effort to inform health care providers and patients of the serious risks associated with the combined use of the medications.

The agency will now require boxed warnings—the FDA’s strongest warning—and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines (nearly 400 products in total), with information about the serious risks associated with using these medications at the same time.

The announcement came after the agency review found the number of patients receiving overlapping benzodiazepine and opioid analgesic prescriptions increased by 41 percent between 2002 and 2014—an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines. The review also revealed that from 2004 to 2011, the rate of emergency department visits involving nonmedical use of both drug classes increased significantly, with overdose deaths involving both drug classes nearly tripling during this period. Recent studies suggest concomitant use of opioid analgesics and other CNS depressants, including alcohol, is also associated with serious adverse events.

“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,” the agency wrote in a safety announcement. “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 FDA said it will continue to examine the evidence on the combined use of benzodiazepines or other CNS depressants with medications used to treat opioid addiction and dependence.

Patients and health care professionals are encouraged to report any side effects involving opioids, benzodiazepines, or other medicines to the FDA MedWatch program.

For related information, see the Psychiatric News article “HHS Takes Actions to Expand Treatment, Research In Opioid Crisis.”