Intravenous Antibiotic Showing Increased Risk of Death Among Users Gets FDA’s Most Critical Warning, Parker Waichman LLP Reports

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The U.S. Food and Drug Administration reports it has notified health professionals about a new Black Box warning for Pfizer Inc.'s intravenous antibacterial drug Tygacil (tigecycline). The FDA says the warning ramp-up is based on additional analysis the regulator conducted on the drug that reveals it is causing an increased mortality rate among users, Parker Waichman LLP cautions.

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Pfizer Inc.'s antibacterial drug Tygacil (tigecycline) is the most dangerous drug of its type available... doctors and other health professionals [have been told] that the drug should only be used when alternative treatments are not suitable.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, notes that, according to a U.S. Food and Drug Administration safety communication issued on Sept. 27, Pfizer Inc.'s antibacterial drug Tygacil (tigecycline) is the most dangerous drug of its type available, and that it has told doctors and other health professionals that the drug should only be used when alternative treatments are not suitable. Tygacil has shown via 10 clinical trials that it is causing an increase in the risk of death among those using the drug either for FDA-approved conditions or unapproved conditions. The FDA also notes that the increase in deaths was among patients with the most severe infections, caused by the infection’s progression. The communication directs Pfizer, maker of the drug, to place a black-boxed warning on the drug's label, noting that this is the regulator’s “strongest warning.”

A previous FDA alert on this drug, issued on Sept. 1, 2010, noted an increased risk of death was seen most clearly when the drug was used for conditions not approved by the FDA, known as off-label uses. In that communication, the regulator indicated that it had updated the "Warnings and Precautions" section of the label to reflect the then-new risks.

Off-label uses that the FDA’s 2010 communication said caused the most clear increased risk of death were:

  •     Treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia); and
  •     Diabetic foot infection.

As the Sept. 27 safety communication indicates, Tygacil was approved by the FDA for the treatment of:

  •     Complicated skin and skin structure infections;
  •     Complicated intra-abdominal infections; and
  •     Community acquired pneumonia.

“There generally is not a lot of brand awareness among consumers when it comes to IV antibiotics, such as Tygacil; based on the FDA’s new findings, we believe it is important to help spread awareness of the fact that it is among the most dangerous of available antibacterial drugs,” said Parker Waichman LLP.

According to a Sept. 27 Associated Press report, Pfizer’s Tygacil revenue was $335 million last year, including $152 million in U.S. sales.

Parker Waichman LLP is a leading mass tort, environmental and personal injury law firm that represents plaintiffs in trip and fall lawsuits in New York, New Jersey, Washington D.C., Florida and nationwide. For more than two decades, Parker Waichman LLP has assisted thousands of clients in receiving fair compensation due to the negligence of others. For more information on Parker Waichman LLP, please visit: or call 1-800-LAW-INFO (1-800-529-4636).

Parker Waichman LLP
Gary P. Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636

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Gary Falkowitz
Parker Waichman LLP

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