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. The two drug types have been increasingly prescribed together by doctors, which has been “associated with adverse outcomes,” despite existing labeling warnings and clinical guidelines cautioning against this type of co-prescription, the FDA said.
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