March 22, 2016 — In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose a
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The Food and Drug Administration will require boxed warnings on the risks of abuse, misuse, addiction, overdose, and death for all immediate-release opioids. The decision is part of the latest wave of efforts by federal officials to combat the ballooning opioid epidemic. It comes a week after the Centers for Disease Control and Prevention issued guidelines recommending nonopioid analgesia for non
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In an attempt to help slow the prescription drug epidemic, the U.S. Food and Drug Administration announced Tuesday that immediate-release opioid painkillers such as oxycodone and fentanyl will now have to carry a “black box” warning about the risk of abuse, addiction, overdose and death. (Source: CNN.com – Health)
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The agency has added a new boxed warning about the risks for misuse, abuse, addiction, overdose, and death and changes the indication to treatment of severe pain with no alternatives. News Alerts (Source: Medscape Neurology and Neurosurgery Headlines)
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Immediate-release versions of addictive meds such as Oxycontin, Percocet and Vicodin to be affected (Source: WebMD Health)
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