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Tigecycline associated with increased risk for death
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The antibiotic tigecycline, which is used to treat antibiotic-resistant organisms, was associated with an increased risk for death, according to researchers with the NIH.
Tigecycline (Tygacil, Pfizer) was approved by the FDA in 2005 based on noninferiority trials. The FDA warned about the possible increased risk for death in 2010, according to background information provided in the study.
The researchers conducted a meta-analysis of studies of tigecycline that took place through April 2011. The analysis included 10 published studies and three unpublished studies. Among the 13 studies, there were 148 deaths in those treated with tigecycline vs. 106 deaths among the patients treated with other antibiotics. The overall mortality rate was increased, with a risk difference of 0.7% (95% CI, 0.1-1.2). Tigecycline was also associated with increased noncure rates, with a risk difference of 2.9% (95% CI, 0.6-5.2).
“Clearly, tigecycline should not be used when other effective antibiotic choices are available,” the researchers wrote. “Using tigecycline in life-threatening infections for which there are few or no alternative agents may be justifiable, but is only supported by anecdotal evidence.”
In an accompanying editorial, John H. Powers, MD,of the NIH, said the data should encourage clinicians to carefully consider whether tigecycline should be administered. However, the trials conducted of the drug were noninferiority trials and were not designed to answer important questions such as the drug’s effect on mortality, which is common in trials of antimicrobial agents.
“The issue is not to make trials perfect,” Powers wrote. “In fact, federal law and legal precedent outline that these issues of appropriate trial design are a minimal standards for drug approval, which when not met, cannot provide adequate evidence regarding drug effects.”
References:
Powers J. Clin Infect Dis. 2012;54:1710-1712.
Prasad P. Clin Infect Dis. 2012;54:1699-1709.
Disclosures:
Disclosure: The researchers report no relevant financial disclosures. Dr. Powers has received consulting fees from Advanced Life Sciences, AstraZeneca, Cardeas, Contrafect, Gilead, Johnson and Johnson, LEO, MethylGene, Novartis, Optimer, Pfizer, Trius, Warner Chilcott and Wyeth, and received funding from Abbott Pharmaceuticals.