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FDA Issues Warning for Pfizer's Antibacterial Tygacil Due to Increased Death Risk

Oct 1, 2013

The antibacterial drug Tygacil (tigecycline) increases risk of death, whether used for purposes approved by the U.S. Food and Drug Administration (FDA) or not approved (known as off-label use), according to the agency. Pfizer Inc. manufactures the drug.

Pfizer must update the drug’s warning and include a so-called “Black Box” label, the FDA’s most serious warning indication. The agency noted that Tygacil, which is administered intravenously, should only be used when other alternative treatments are not available, according to Reuters.

Tygacil received FDA approval in 2004 for the treatment of complicated skin and abdominal infections and community-acquired bacterial pneumonia; Tygacil is not approved for the treatment of diabetic foot infection or hospital-acquired pneumonia, Reuters reported.

The agency issued a physician reminder in September 2010 stating that Tygacil carried an increased risk of death when compared to other medications prescribed for the treatment of infection, according to Reuters. At that time, the agency stated that it had reviewed pooled clinical trial data and concluded that most of the deaths were related to infection progression. The FDA also indicated that the increased death risk was, for the most part, seen in patients diagnosed with hospital-acquired pneumonia, although the risk had been seen in patients diagnosed with other types of infection. At that time, the agency updated the "Warnings and Precautions" section of the label to reflect the increased risks, Reuters reported.

The agency indicated that it has reviewed data from 10 trials since the 2010 notice. The trials involved patients who had taken the drug only for FDA-approved uses. Reuters wrote that the review revealed an increased risk of death even when taken for approved uses when compared to other antibacterial medications. The current review confirmed the prior analysis, The Associated Press (AP) noted.

Deaths were tied to infections that grew worse or infections that resulted in complications. Deaths also resulted from other underlying medical conditions, according to the FDA. Risks were greatest in patients diagnosed with ventilator-assisted pneumonia, an unapproved Tygacil use, according to the AP.

According to the FDA, it is unclear why Tygacil is tied to increased death risks when compared to other drugs.

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