FDA evaluates bleeding incidence in patients taking bloodstream infection drug

2/4/2009

ROCKVILLE, Md. A study published in the journal Critical Care Medicine has led the Food and Drug Administration to look into the incidence of bleeding in patients taking a drug for bloodstream infection.

The FDA announced Wednesday that it is working with Indianapolis-based drug maker Eli Lilly & Co. to evaluate the incidence of serious bleeding in patients using Xigris (drotrecogin alfa activated). The study, accompanied by an editorial, reviewed medical records of 73 patients taking Xigris and found that 35% of those with a bleeding risk factor experienced serious bleeding, compared to 3.8% of those without bleeding risk factors. Of those patients with the factors 65% died, compared with less than a quarter of those without.

Xigris' labeling includes a warning that bleeding is the most common serious side effect and lists several risk factors that may cause bleeding. The FDA is not recommending, however, that prescribers stop administering Xigris.

The agency said it would announce its conclusions and any recommendations when it completes its review of the drug, though it said that could take several months.

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