FDA will require stronger warnings for certain opioid medications : marketwatch

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FDA will require stronger warnings for certain opioid medications

FDA will require stronger warnings for certain opioid medications
FDA will require stronger warnings for certain opioid medications
The Food and Drug Administration said Wednesday it will require stronger warnings on certain opioid medications and central nervous system depressant drugs among other labeling changes intended to reverse a nationwide opioid addiction epidemic.The agency will require boxed warnings, "the FDA's strongest warning," and medication guides for patients stating the serious risks connected to using the nearly 400 products, including prescription oxycodone, hydrocodone, and morphine or opioid-containing cough products.The new measures, which cover opioid analgesics and a class of central nervous system depressant drugs called benzodiazepines, are intended to raise awareness among patients and health care providers of risks like death, coma and respiratory depression, the agency said.


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

FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
After an extensive review of the latest scientific evidence, the U.S. Food and Drug Administration announced today that it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.Among the changes, the FDA is requiring boxed warnings – the FDA's strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines – nearly 400 products in total – with information about the serious risks associated with using these medications at the same time.Risks include extreme sleepiness, respiratory depression, coma and death.


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FDA will require stronger warnings on hundreds of opioid medicines

FDA will require stronger warnings on hundreds of opioid medicines
FDA will require stronger warnings on hundreds of opioid medicines
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