Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The FDA recently issued a notice to critical health care professionals warning of the risk of serious bleeding events and mortality in patients who received Xigris, a medication approved by the FDA for the treatment of adult high-risk severe sepsis. Sepsis is a common, deadly and underdiagnosed disease that can develop as a complication after illnesses such as pneumonia and bacterial infections. High-risk sepsis is sepsis associated with acute organ dysfunction. Xigris is indicated when cardiovascular, renal or respiratory dysfunction occurs with severe sepsis.

The notice is the result of a retrospective study in patients with severe sepsis and baseline bleeding precaution that showed an increased risk of serious bleeding events and death in patients with those risk factors who received drotrecogin alfa, which is marketed as Xigris.

The increased risks are described in the drug’s prescribing information under Contraindications and the Warnings and Precautions of the medication’s package insert, and says that bleeding is the most common serious adverse reaction experienced by patients who received Xigris. The Contraindications section also states that Xigris should not be used in clinical situations where the patient has active internal bleeding, recent hemorrhagic stroke, recent intracranial or intraspinal surgery or severe head trauma, trauma with an increased risk of life-threatening bleeding, presence of an epidural catheter, or intracranial neoplasm or mass lesion or evidence of cerebral herniation.

The warnings and contraindications are consistent with the information in the current product label. Those who prescribe the medications should refer to the label warnings, precautions and contraindications and weigh the patient’s risks against benefits before prescribing Xigris.

FDA and Xigris are continuing to evaluate the incidence of serious bleeding events and mortality in patients who receive Xigris and will give its conclusions and any recommendations once the review is complete. Healthcare professionals and patients should report any side effects of Xigris to the FDA’s MedWatch Adverse Event Reporting Program.

This entry was posted on Sunday, February 8th, 2009 at 8:00 am and is filed under product liability, safety. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.