Issuing new warning labels, FDA urges caution in prescribing opioids, benzodiazepines

WASHINGTON – As part of the U.S. Food and Drug Administration’s Opioids Action Plan, the agency recently issued new regulations imposing strong warning labels on nearly 400 medications. Specifically, the agency is requiring boxed warnings, the FDA’s strongest warning, and patient-centered medication guides for prescription opioid painkillers, cough products with opioids and benzodiazepines that warn patients of the risks of using these medications in tandem. Such risks, the FDA reported, range from extreme sleepiness, respiratory problems and depression to coma and death. Benzodiazepines are typically prescribed to treat anxiety, insomnia and seizure disorders, as well as other neurological and/or psychological disorders.

The agency’s Opioids Action Plan implements policies designed to reverse the prescription opioid abuse epidemic while still ensuring that patients who need pain medications receive safe, effective and appropriate pain management medications.

“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, FDA Commissioner Dr. Robert Califf said in a statement. “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 … together outweigh these serious risks.”

With practitioners increasingly prescribing these medications together, patient outcomes are problematic at best. The FDA reported that the number of patients who were prescribed both an opioid analgesic and a benzodiazepine increased by 41 percent – representing more than 2.5 million patients – between 2002 and 2014.

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