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Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Warns of Combined Opioid Product Use

FDA news release; 2016 Aug 31

As part of its Opioids Action Plan aimed at reversing the prescription opioid abuse epidemic, the FDA is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks and potential adverse events associated with the combined use of opioid medications and benzodiazepines. Among the required FDA changes:

  • Boxed warnings—the FDAs strongest warning—and patient-focused Medication Guides for prescribing opioid analgestics, opioid-containing cough products, and benzodiazepines will be required with information about the serious risks associated with using these medications at the same time.
  • Opioid analgesics, prescription opioid cough products, and benzodiazepines will be required to have slightly different labeling.
  • A Drug Safety Communication was issued to reach both health care professionals and the public regarding the risks of using these products together.


The US Food and Drug Administration. FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use. FDA Web site. August 31, 2016. Accessed September 4, 2016.


In 2014 more people died of drug overdoses than in any previous year, and 60% of the deaths were from opioid use. The number of drug-related deaths has quadrupled since 1999. It is now estimated that 1 out of 5 patients with non-cancer pain are prescribed opioids in office-based settings. While pain specialists prescribe many pain medications, over half of pain medications are prescribed by primary care physicians.1,2 The number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014, or an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines. It is clear that while some patients may need both benzodiazepines and opioids, it is a potentially dangerous combination and physicians should be cautious about using these medications together and minimize the frequency with which this happens. —Neil Skolnik, MD

1. Centers for Disease Control and Prevention. Injury prevention & control: Opioid overdose. Accessed September 9, 2016.

2. Centers for Disease Control and Prevention. Injury Prevention & Control: Opioid Overdose. Accessed September 9, 2016.