Sept 27 2013: The U.S. Food and Drug Administration (FDA) is warning that an additional analysis shows an increased risk of death with use of the intravenous (IV) antibiotic, Tygacil (tigecycline). A new Boxed Warning about this risk is to be added to the Tygacil drug label, and the Warnings and Precautions and the Adverse Reactions sections of the drug information will be updated. A Boxed Warning is the strongest warning given to a drug. These changes are based on an analysis that was conducted following an initial Drug Safety Communication about this concern in September 2010

Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. Tygacil is FDA-approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia. Patients and their caregivers should talk with their health care professionals if they have any questions or concerns about Tygacil.

Data from 10 clinical trials conducted only for FDA-approved uses of this drug showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% vs. 1.8%, respectively. The adjusted risk difference for death was 0.6%. In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

The latest Tygacil label can be accessed on the FDA webpage: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf