FDA Requires Stronger Warning Labels on Opioids and Benzodiazepines

"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 FDA Commissioner Dr. Robert Califf, M.D. "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 CNS depressants more generally – together outweigh these serious risks."

FDA announced Aug. 31 that it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines. FDA is requiring boxed warnings – its strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines, that is, a group of nearly 400 products in total. They now must communicate the serious risks associated with using these medications at the same time.

Those risks include extreme sleepiness, respiratory depression, coma, and death. This move is part of the agency's Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic while still providing effective, appropriate pain management.

"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 FDA Commissioner Dr. Robert Califf, M.D. "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 CNS depressants more generally – together outweigh these serious risks."

FDA also announced that, given the importance of reaching health care professionals and the public with information about the risks of using these products together, it issued a Drug Safety Communication. "Through the Drug Safety Communication and by requiring patient Medication Guides, the agency also provides information for anyone who is taking, or who knows someone taking, either of these types of medications and encourages them to better understand the risks of taking them together; and, when it is medically necessary, for health care providers to be careful to prescribe them as directed, without increasing the dose or dosing frequency for either drug," FDA said.

The agency found that from 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths involving both drug classes nearly tripling during that period and the number of patients who were prescribed both up by 41 percent between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.

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