The "black box" warns of known dangers linked to combined use of the products and will appear on labels of more than 400 products.
As part of an ehanced effort to quell rising death rates linked to use of both opioids and benzodiazepines, the FDA requires new class labeling for both groups that warns against prescribing them together. More than 400 products, including opioid-containing cough suppressants, are affected.Pain specialist Steven King, MD, points out that co-prescribing of these drugs is far from a novel practice and has reservations about the ultimate impact of the added guidance.Click through his overview above. And, please, tell us what you're thinking, below.Â Â Â
1. USFDA. Safety Labeling Change Notification. www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM518615.pdf
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5. FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use [press release]. Silver Spring: US Food and Drug Administration; September 19, 2016.
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