Xigris, a drug made by Eli Lilly, has drawn the scruting of federal regulators. The FDA is looking at Xigris, which is used to treat severe sepsis or blood infections, to determine a possible risk that the drug may cause serious bleeding. According to the FDA, a retrospective study of 73 patients who used Xigris, showed an increased risk of serious bleeding and death. A description of the risk of bleeding is already on the drug’s label. The retrospective study that drew the FDA’s attention was published in the journal Critical Care Medicine, and an accompanying editorial indicated that doctors should not give Xigris to sepsis patients who already have an increased risk for bleeding problems.
Studies, like the one published in Critical Care Medicine, can help uncover patterns of side effects and increased risks that come with prescription medications. It is important for the FDA to follow-up with such studies to determine the risk to the public. The FDA can then take appropriate steps with respect to the medication, such as label changes or recalls.