The Food and Drug Administration (FDA) announced class-wide drug labeling changes for opioid and benzodiazepine products on August 31 to help patients and doctors better understand the potentially life-threatening risks of combining anti-anxiety or sleep medications with prescription opioids.
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)…
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. Risks include extreme sleepiness, respiratory depression, coma and death.
The agency is taking this action after an extensive review of the latest scientific evidence revealed that physicians have been increasingly prescribing opioids and benzodiazepines together, which has raised the risk of adverse outcomes. From 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths (from taking prescribed or greater than prescribed doses) involving both drug classes nearly tripling during that period.
In the announcement, FDA stressed its commitment to collaborating with the healthcare community and federal and state partners—as underscored in NACDS-backed, bipartisan legislation signed into law this year, S. 483, the Ensuring Patient Access and Drug Enforcement—to help reduce opioid misuse and abuse and improve appropriate opioid prescribing, while ensuring that patients in pain continue to have appropriate access to opioid analgesics.
