FDA Warns Of Mortality Risks From Wyeth Antibiotic

Law360, New York (September 2, 2010, 7:25 PM EDT) -- The U.S. Food and Drug Administration has announced that it will alter the warning label on the antibiotic Tygacil after clinical trials showed an increased risk of death associated with the Wyeth product.

“Alternatives to Tygacil should be considered in patients with severe infections,” the agency stated in its recommendation.

The FDA also sent out “Dear Healthcare Professional” letters reminding doctors of the risk Tygacil poses as compared with other treatments for severe infections. The letters and labels carefully point out, however, that the greatest mortality...
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