[9-27-2013] The U.S. Food and Drug Administration (FDA) is warning that an additional analysis shows an increased risk of death when intravenous (IV) Tygacil (tigecycline) is used for FDA-approved uses as well as for non-approved uses. As a result, we approved a new Boxed Warning about this risk to be added to the Tygacil drug label and updated the Warnings and Precautions and the Adverse Reactions sections. A Boxed Warning is the strongest warning given to a drug. These changes to the Tygacil label are based on an additional analysis that was conducted for FDA-approved uses after issuing a Drug Safety Communication (DSC) about this safety 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 (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP). 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.
In the 2010 DSC, we informed the public that a combined analysis, or meta-analysis, of 13 Phase 3 and 4 trials showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 4.0% (150/3788) vs. 3.0% (110/3646) respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.1, 1.2). The increased risk was greatest in patients treated with Tygacil for ventilator-associated pneumonia, a use for which FDA has not approved the drug.
Since issuing the 2010 DSC, we analyzed data from 10 clinical trials conducted only for FDA-approved uses (cSSSI, cIAI, CABP), including trials conducted after the drug was approved. This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.