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FDA to start requiring boxed warnings on opioids, benzodiazepine

August 31, 2016 Silver Spring, Md. — The U.S. Food and Drug Administration announced Aug. 31 that it plans to require boxed warnings for prescription opioid analgesics, opioid-containing cough products and benzodiazepines.

Boxed warnings are the FDA's strongest warning. According to FDA, the new requirements will apply to some 400 products and will include information on the serious risks associated with using these types medications at the same time.

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said Robert Califf, M.D, FDA commissioner. "We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines — or central nervous system depressants more generally — together outweigh these serious risks."

Among the data it reviewed prior to changing the warning label, the FDA concluded that from 2004 to 2011, emergency department visits "involving nonmedical 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." The agency also noted that the number of patients prescribed both an opioid analgesic and benzodiazepine "increased by 41 percent between 2002 and 2014."

For more information, visit the FDA website.