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Michael Monheit
Michael Monheit
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FDA Warning that Pfizer’s Tygacil Increases Risk of Death

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The drug Tygacil, sold by Pfizer, has been linked to an increased risk of death when used for approved conditions, as well as unapproved conditions, warns the U.S. Food and Drug Administration (FDA).

The drug company is required to place a black box warning on the drug’s label to indicate the risk of the serious nature of using the drug. The agency said, the antibacterial drug, which is typically administered through an IV, should be used only when alternative treatments are not available.

Tygacil (tigecycline), was initially approved for the treatment of complicated skin and abdominal infections as well as community-acquired bacterial pneumonia. However, it is not approved for treating diabetic foot infection or hospital-acquired pneumonia.

The FDA issued another warning to doctors regarding the serious risk of death, in September 2010. At the time, the agency said it had analyzed clinical data and found that most deaths were associated with progression of the infection. The agency further stated that the increased risk of death was seen mostly in those patients with hospital-acquired pneumonia, although, it was seen in patients with other infections. The “Warnings & Precautions,” section of the label was updated to reflect these risks. The agency, since issuing that notice in 2010, has analyzed data gathered from 10 trials of patients that took Tygacil, for FDA-approved use only. The analysis showed a higher risk of death in comparison to other antibacterial drugs.

Public Citizen, a drug safety watchdog, petitioned the agency in 2011 to have a black box warning added to Tygacil’s label, says the actions of the FDA come far later than it should have, stating “the failure of the FDA to require black box warning years ago is inexcusable.”

A Pfizer spokeswoman, in a statement, said: “due to the increase in antibiotic resistance worldwide, Tygacil continues to be an appropriate treatment option for its approved indications.”

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