FDA OKs Boxed Death Risk Alert For Pfizer Antibiotic

Law360, New York (September 27, 2013, 6:24 PM ET) -- The U.S. Food and Drug Administration on Friday greenlighted a new box warning that cautions doctors and consumers about the higher risk of death from the use of Pfizer Inc.'s antibiotic Tygacil, frequently used to treat complicated skin and abdominal infections.

The agency said that the boxed warning is its most serious warning issued for drugs and that the move came after an additional analysis conducted about the use of the drug for FDA-approved uses, according to a safety announcement it made Friday. It had conducted...
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