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Drug safety- FDA concern about black box warning

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Dear Members,Black box warnings are

the most serious warnings imposed by the FDA for prescription medications and

highlight potentially fatal, life-threatening, or disabling adverse effects for

prescription drugs.

Black box warnings may

include information regarding restriction of use and/or distribution of

medications. The FDA mandates that black box warnings be separated and

highlighted from the other text in the package insert and typically are

characterized with a black box border.Tarun Wadhwa

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