(Updates to add details)

   By Jennifer Corbett Dooren
   Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--The Food and Drug Administration said Wednesday that Pfizer Inc.'s (PFE) antibiotic Tygacil was associated with an increased risk of death compared with other drugs when used to treat certain kinds of serious infections.

The agency said the greatest increase in the death risk was seen when Tygacil was used to treat a type of hospital-acquired pneumonia known as ventilator- associated pneumonia. Tygacil is approved to treat only community-acquired pneumonia along with certain skin and intra-abdominal infections. The FDA also said it saw a small increase in deaths among patients with diabetic foot infections being treated with Tygacil compared to other drugs. Tygacil is not approved to treat such infections.

However, the FDA said there was also an increased death risk seen with patients who had the types of infections that Tygacil is approved to treat, and suggested that doctors consider other drugs when treating patients with severe infections.

The FDA said it looked at 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection comparing the overall mortality for Tygacil with other antibiotics. Overall, the studies showed death occurred in 4% of patients receiving Tygacil, or 150 out of 3788, and 3% of patients, or 110 of 3646, receiving comparator antibiotics.

Tygacil's label has already been updated to warn doctors about the death risk and Pfizer sent a letter dated July 26 to health care professionals detailing the new label.

In a statement, Pfizer said it worked proactively with the FDA to update the prescribing information for Tygacil.

"Because of the broad spectrum of coverage of Tygacil and increasing rates of resistance to other antibiotics, Pfizer believes that Tygacil remains an important treatment option for appropriate patients," the company said.

Tygacil is administered intravenously and was approved in the U.S. in 2005.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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  (END) Dow Jones Newswires
  09-01-10 1240ET
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