Tigecycline gets warning for mortality risk

The label of tigecycline (Tygacil) has been revised to warn of an increased mortality risk associated with the drug compared to other antibiotics, according to a recent FDA announcement.

The increased risk was found using a pooled analysis of 13 clinical trials, in which death occurred in 4.0% (150/3788) of patients receiving tigecycline and 3.0% (110/3646) of patients receiving comparator antibiotics. The cause of the excess deaths is uncertain, but it is likely that most deaths in patients were related to progression of the infection, the FDA said. The agency advises that alternative medications be considered in patients with severe infections.

The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. Tigecyline is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection, but it is approved for complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired pneumonia.