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Tigecycline Is Associated with Increased Mortality
The FDA recently alerted clinicians that, in a pooled analysis of clinical trials, the risk for death was higher with tigecycline than with comparator drugs.
Tigecycline is a relatively new antibiotic with a unique spectrum of activity that includes some multidrug-resistant organisms (e.g., methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, extended-spectrum β-lactamase–producing bacteria, Acinetobacter spp.). The drug is FDA approved for treating complicated skin and skin-structure infections, complicated intra-abdominal infections, and community-acquired pneumonia, caused by susceptible pathogens.
On September 1, 2010, the FDA alerted healthcare providers that, in a pooled analysis of 13 clinical trials, tigecycline was significantly associated with increased risk for all-cause mortality (overall adjusted mortality rate, 4% with tigecycline vs. 3% with comparators). The mortality rates with tigecycline were increased (although not significantly so) for each individual indication. The increase was greatest for ventilator-associated pneumonia — an indication for which tigecycline is not FDA approved because of lower cure rates and excess mortality. The FDA recommends that clinicians consider alternatives to tigecycline for severe infections.
Comment: The FDA noted that most deaths were probably related to progression of infection, but the actual causes remained uncertain. The FDA also suggested that one possible explanation for the excess mortality with tigecycline is the drug's bacteriostatic mode of action. However, for the types of infections studied, bactericidal activity is not generally thought to be required. Blood levels of tigecycline are very low, so secondary bacteremia would be problematic.
In 2007, a meta-analysis showed increased mortality with cefepime — a finding that was subsequently refuted. Hopefully, more data on tigecycline will be forthcoming, and the present alert will not prove to be another false alarm.
Published in Journal Watch Infectious Diseases September 8, 2010
Citation(s):
FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. Rockville, MD: Food and Drug Administration; Sep 1 , 2010. (http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm)
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