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Boxed Warnings Mandatory for Opioids and Benzodiazepines


In response to increasing combined misuse of both drug classes, the FDA requires all formulations to carry its strongest warning.

In this Medical News Minute created for Consultantlive.com, Dr Bobby Lazzara reviews FDA’s recent decision to require boxed warnings on labels for both opioid- and benzodiazepine-containing medications that alert patients and healthcare professionals to the extreme risk involved in taking drugs from both classes together. The danger is not news but the agency’s Opioid Action Plan that supports policies designed to reverse the current opioid abuse epidemic includes stepped-up strategies like this one to keep the issue in high relief for prescribers as well as the public.

FDA studies show an escalation in the rate at which opioids and benzodiazepines are being prescribed together. The decision to institute class labeling for both chemical entities and formulations that include them was based, in part, on citizen petitions from local and state public health and other officials to do more to rein in rampant opioid misuse and abuse.



FDA Safety Alert

FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use

FDA Drug Safety Communication  

Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death


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