Xigris Linked to Increased Risk of Deaths, FDA Announces Safety ReviewFeb 4, 2009 | Parker Waichman LLP
Xigris, a treatment for sepsis made by Eli Lilly, is now the subject of a Food & Drug Administration (FDA) safety review. The review was prompted by a study that showed Xigris (known generically as Drotrecogin alfa) increased the risk of dangerous internal bleeding when used by patients with a recent history of hemorrhages.
Xigris is similar to a natural protein produced by the body. In patients with severe, life-threatening sepsis, Xigris decreases inflammation and the formation of blood clots in blood vessels. It also increases the breakdown of blood clots.
Sepsis - also known as blood poisoning - is a serious medical condition characterized by a whole-body inflammatory state (called a systemic inflammatory response syndrome or SIRS) and the presence of a known or suspected infection. Sepsis can develop as a complication after common illnesses such as pneumonia and bacterial infections. Sepsis causes approximately 1400 deaths worldwide each day.
An FDA Early Communication on the Xigris safety review cited a study that followed 73 sepsis patients who were treated with Xigris. The study found that serious internal bleeding occurred in 35 percent of patients with a history of bleeding problems, compared with 3.8 percent of patients with no such history.
The FDA said it plans to consult with Eli Lilly and reevaluate the drug's labeling in the coming months. The agency said prescribers should refer to the product label for the specific contraindications, warnings, and precautions. The should carefully weigh the increased risk of bleeding against the benefits of Xigris.
The current prescribing information for Xigris describes the increased risk of bleeding, and includes a statement in the Warnings and Precautions section that bleeding is the most common serious adverse reaction experienced by patients who received the drug. The Warnings and Precautions section also lists a number of risk factors for the increased risk of bleeding that should be taken into account when considering use of Xigris therapy. The Contraindications section states that Xigris is not to be used in the following clinical situations where bleeding could lead to significant morbidity or death:
- Active internal bleeding
- Recent (within 3 months) hemorrhagic stroke
- Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma
- Trauma with an increased risk of life threatening bleeding
- Presence of an epidural catheter
- Intracranial neoplasm or mass lesion or evidence of cerebral herniation