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FDA Mandates Warnings for Use of Several Opioid Products

October 13, 2016

The US Food and Drug Administration (FDA) has mandated a strong warnings for the combined use of opioid analgesics, prescription opioid cough products, and benzodiazepine labeling. The combined use of these products are linked to some serious risks and death.

The new requirement focuses on its labeling including a boxed warning and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines.

The reported risks of using these combined products are: extreme sleepiness, respiratory depression, coma and death.

This action is part of FDA’s Opioid’s Action Plan aiming to create policies for the prescription opioid abuse epidemic.

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