9.01.10 – TYGACIL WARNING FOR INCREASED MORTALITY
FDA has issued a reminder of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil® (tigecycline) 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 patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. Alternatives to Tygacil should be considered in patients with severe infections. For additional information, see the FDA MedWatch website.