Intravenous Tigecycline Gets a Boxed Warning from the FDA

In a Boxed Warning, the FDA indicates that use of intravenous tigecycline is associated with increased all-cause mortality risk and that the drug should be reserved for situations in which alternative treatments are not suitable. The revised product label states that tigecycline should be used only to treat or prevent infections caused by bacteria that are susceptible to the drug.

The new warning updates a 2010 FDA safety alert about an increased risk for death from tigecycline that was most clearly seen in patients with ventilator-associated pneumonia, an indication for which tigecycline is not approved (NEJM JW Infect Dis Sep 8 2010). Since then, the FDA has analyzed data from 10 clinical trials that tested only FDA-approved uses of tigecy…