UPDATE 1-US FDA warns Pfizer's drug Tygacil raises risk of death

Reuters

(Corrects 2012 sales figure for Tygacil to $335 mln from $86mln, paragraph 8)

Sept 27 (Reuters) - Pfizer Inc's antibacterial drugTygacil increases the risk of death whether used as authorizedby the U.S. Food and Drug Administration or for unapprovedconditions, the agency warned on Friday.

Pfizer must place a warning inside a black box on the drug'slabel, indicating the risk is of the most serious nature. TheFDA said the drug, which is usually given intravenously, shouldonly be used when alternative treatments are not suitable.

The drug is approved to treat complicated skin and abdominalinfections and community-acquired bacterial pneumonia. It is notapproved to treat diabetic foot infection or hospital-acquiredpneumonia.

In September 2010, the FDA issued a reminder to physiciansthat Tygacil carried a higher risk of death than other drugsused to treat infection. The agency said at the time it hadanalyzed pooled clinical trial data and determined that mostdeaths were related to progression of the infection.

The agency said the increased risk of death was mostly seenin patients with hospital-acquired pneumonia though it was alsoseen in patients with other types of infection. The agencyupdated the "Warnings and Precautions" section of the label toreflect risks.

Since issuing that 2010 notice, the FDA said it has analyzeddata from 10 trials of patients who took the drug only forFDA-approved uses. This analysis also showed a higher risk ofdeath compared to other antibacterial drugs.

In general, the deaths resulted from worsening infections,complications from infection or another underlying medicalcondition, the agency said.

Tygacil was approved in the United States in 2005. Itgenerated sales in 2012 of $335 million.

Pfizer did not immediately respond to a request for comment.

The drugmaker's shares were up 42 cents, or 1.5 percent, to$28.94 in midday trade on the New York Stock Exchange. (Reporting by Toni Clarke in Washington; Editing by LeslieGevirtz)

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