Argentinian Researcher Warns of Higher Mortality Rates Associated with Tygacil

Argentinian Researcher Warns of Higher Mortality Rates Associated with Tygacil

By Jessica Tyner

Daniel Curcio is a researcher at the Hospital Municipal Chivilcoy in Argentina — and also a speaker for Pfizer Argentina (formerly Wyeth SA), which manufacturers the antibiotic Tygacil (tigecycline). However, even with this conflict of interest, Curcio recently published research in the Brazilian Journal of Infectious Diseases showing that patients who were treated with Tygacil face a much higher mortality rate than those treated with other types of antibiotics.

The subjects in question were hospitalized for ventilator associated pneumonia (VAP), and Curcio states that the researchers “determined the mortality predictor factors between survivors and nonsurvivors patients treated with tigecycline. Patients were enrolled in the study at 23 Latin American centers between February 2006 and June 2009.”

The number of Tygacil lawsuits is growing steadily, right on the tail of the U.S. Food & Drug Administration (FDA) requiring a black box warning label on the drug, the most serious of all warnings.

The new black box warning label reads: “All-cause mortality. An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in Tygacil-treated patients versus comparator. The cause of this mortality risk difference of 0.6% has not been established. Tygacil should be reserved for use in situations when alternative treatments are not suitable.”

However, researchers like Curcio were looking at Tygacil mortality rates years before the FDA stepped in. They were able to bring together a sampling of 301 patients, and “208 patients were male and the mean age was 49.7 (range 18-86). The overall in-hospital mortality was 36.5%.” <

Curcio and his team also considered age, whether or not the patients were in the intensive care unit, their APACHE II score, VAP diagnosis, and documentation of microbiological factors. “In concordance with the FDA warning, our study shows that in-hospital mortality with tigecycline was significantly higher in critically ill patients with VAP,” Curcio’s report notes. In essence, the tougher the ailment is, the more vulnerable the patient seems to be when taking Tygacil as an antibiotic. 

“Undoubtedly, from a strictly scientific point of view, there is no evidence to support tigecycline use in these patients.” In fact, according to Curcio, there are “reported significantly lower cure rates in clinically evaluable patients with VAP treated with tigecycline (47.9%) when compared to imipenem. Based on these results, tigecycline has not been approved by the FDA for the treatment of VAP.”

However, people are prescribed antibiotics, including Tygacil, for a number of ailments. Many critics, including doctors, even claim that antibiotics in general are over-prescribed. The drug is designed to “treat infections caused by bacteria,” which can of course include pneumonia — although Curcio claims that Tygacil isn’t a proper treatment for VAP. He says that the recommended dosage of the drug “is probably underdosed for the treatment of VAP caused by typical, extracellular-acting bacteria.” However, he also states that even with this evidence, the profile of Tygacil is designed to “encourage physicians to use the drug for VAP.”

Did You Take Tygacil?

If you were prescribed Tygacil and suffered serious complications, or you lost someone to Tygacil, you may have a Tygacil legal claim. Find out more about what you can do by visiting the Tygacil (Tigecycline) Class Action Lawsuit Investigation. Once you submit your information, an attorney will contact you if you qualify for a complimentary Tygacil claim review. 

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