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Black box warnings added for opioid, benzodiazepines that can harm in combination

Federal authorities will now require the public be warned about the potentially dangerous combination of prescription opioids with a class of drugs called benzodiazepines that are commonly used to treat depression and anxiety.

The so-called "black box" warning, the strongest required by the U.S. Food and Drug Administration, will inform patients and prescribers about the serious risks from mixing benzodiazepines and opioids used in painkillers and cough medications.

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The labels will go on almost 400 drug products and will warn of risks including extreme sleepiness, respiratory depression, coma and death, according to the FDA.

The move comes on the heels of a petition drive by state and local public health officials asking for the extra labeling to avoid those serious problems.

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"Doctors and public health leaders have spoken out about what we are seeing on the frontlines in our cities and states, and the FDA has changed its policies to help us protect the health and well-being of our communities," said Dr. Leana Wen, Baltimore City's health commissioner, who signed the petition. "This is an incredible demonstration of how the FDA listens to citizens; how public health leadership matters; and how all of us can and do make a difference."

In Maryland, the state reported 351 opioid related deaths last year and 91 benzodiazepine related deaths.

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