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State Health Officials Petition FDA for New Warnings on Opioids, Benzodiazepines

March 2, 2016

FDA“Concerns over the risks of co-prescribing benzodiazepine and opioid drugs has 41 state health officials petitioning the US Food and Drug Administration (FDA) to place a new black box warning on both classes of pharmaceuticals to warn patients and doctors of the potential risks with concomitant use.

“Only a few labels and medication guides contain specific information on the dangers of concurrent use of these two classes of medications; none contain black box warnings,” the officials write in their petition submitted Monday, calling for all labels for opioids to read:

“WARNING: CONCURRENT USE WITH BENZODIAZEPINES [replace with OPIOIDS on benzodiazepine labels] REDUCES THE MARGIN OF SAFETY FOR RESPIRATORY DEPRESSION AND CONTRIBUTES TO THE RISK OF FATAL OVERDOSE, PARTICULARLY IN THE SETTING OF MISUSE.”

See more at: http://www.raps.org/Regulatory-Focus/News/2016/02/22/24382/State-Health-Officials-Petition-FDA-for-New-Warnings-on-Opioids-Benzodiazepines/

Source: RAPS.org – February 22, 2016

Categories: News Updates, Opioids
Tags: Benzodiazepines, FDA, Prescription Opioids

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