Yes. In 2011, drugmaker Eli Lilly withdrew Xigris (common name drotrecogin alfa) from U.S. markets after a study showed that the drug was not only ineffective, but posed significant health problems.
Xigris was created to treat severely ill patients suffering from sepsis and septic shock. Sepsis can occur after a life-threatening illness, such as pneumonia or severe infections, and can cause infection to spread rapidly. Sepsis can eventually cause organ failure. Xigris is given by intravenous infusion to adult patients who have suffered multiple organ failure due to sepsis.
The drug was officially withdrawn after a study published in the New England Journal of Medicine showed that Xigris failed to prevent patient death, but the FDA had long warned against potential bleeding problems even when the drug was in regular use. In fact, the FDA warned against known bleeding risks of Xigris in patients who had:
- Suffered single organ dysfunction
- Undergone recent surgery
- Active internal bleeding
- Suffered a hemorrhagic or ischemic stroke in the past three months
- Suffered recent severe head trauma, or intracranial or intraspinal surgery
- Suffered trauma that increased the risks of internal bleeding
- Had an epidural catheter in place
- Showed evidence of intracranial neoplasm, cerebral herniation, or mass lesion
- Been diagnosed with chronic severe hepatic disease
- Been treated with heparin or other blood thinners
- Had been given aspirin in the past seven days
- A history of bleeding or clotting problems
What Should I Do If I Suspect a Bleeding Injury?
If you or someone you love suffered ill effects after Xigris treatment, you should speak with the attorneys at Wayne Wright LLP as soon as possible. We can investigate the circumstances of your case and tell you whether you may be owed compensation for your losses. Call 800-237-3334 today to tell your story to an attorney at no cost to you.