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Public Citizen, Partners Petition FDA for Black-Box Warnings on Opioids, Benzodiazepines About Dangers of Concurrent Use

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August 31, 2016, Final response letter from the FDA.

Public Citizen and partners including several representatives of state health departments petition the Food and Drug Administration (FDA) to require black-box warnings on the labels of opioid painkillers and benzodiazepine tranquilizers to warn of the dangers of concurrent use. There are more than 14,000 deaths in the U.S. each year due to overdose of prescription opioid painkillers, and a rapidly increasing proportion of these deaths occurs in people prescribed benzodiazepines as well as opioids. This increase is not registering with prescribing doctors, however, necessitating a change in the labeling of these medications to better inform and protect patients.

See our other work related to opioids