US FDA makes label change on Pfizer's Tygacil to reflect increased mortality risk

The US Food and Drug Administration has issued an alert reminded health care professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) marketed by global drugs behemoth Pfizer (NYSE: PFE) compared to that of other drugs used to treat a variety of serious infections.

The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in people with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. The FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of the drug.

Tygacil, originated by Wyeth which Pfizer acquired last year, was approved by the FDA in 2005 for the treatment to treat complicated skin infections, intra-abdominal infections and community-acquired pneumonia. It is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia).