U.S. FDA warns Pfizer's drug Tygacil raises risk of death


By Toni Clarke

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 FDA said the increased risk of death was mostly seen inpatients 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 Tygacil, knowngenerically as tigecycline, only for FDA-approved uses. Thisanalysis also showed a higher risk of death compared to otherantibacterial drugs.

Public Citizen, a drug safety watchdog, which petitioned theFDA in 2011 to place a black box warning on Tygacil, said theFDA's action comes far later than it should have.

"The failure of the FDA to require a black box warning yearsago is inexcusable," the group said in a statement.

According to the FDA, patients who took Tygacil forauthorized uses had a 2.5 percent risk of death, compared with a1.8 percent risk of death for those who took other antibacterialdrugs.

A spokeswoman for Pfizer, Kimberly Bencker, said that "dueto the increase in antibiotic resistance worldwide, Tygacilcontinues to be an appropriate treatment option for its approvedindications."

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

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

Pfizer's shares were up 34 cents, or 1.2 percent, at $28.86in afternoon trading on the New York Stock Exchange.

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