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Xigris (drotrecogin alfa) withdrawn worldwide
- Starting date:
- October 25, 2011
- Posting date:
- October 25, 2011
- Type of communication:
- Information Update
- Subcategory:
- Biologic/vaccine
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-110004632
Health Canada is informing Canadians that it is working with Eli Lilly Canada, Inc. to withdraw the drug Xigris (drotrecogin alfa) from the Canadian market, in light of the company's decision to withdraw Xigris from the market worldwide.
Xigris is used solely in hospital intensive care units to treat patients at a high risk of death due to serious complications of a blood infection (called sepsis or septic shock). Sepsis is a serious medical condition involving infection and generalized inflammation. The body's normal response to an infection is to set off a limited chain reaction to fight the infection. In severe sepsis, this systemic immune response becomes overactive and can result in damage to vital body organs, leading to bleeding, organ failure and, in many cases, to death. Xigris is used in serious cases only, in addition to other sepsis treatments.
The withdrawal is in light of a large international clinical trial, known as the Prowess-Shock study that showed no benefit for patients receiving Xigris compared to patients who did not receive it.
Health Canada is working with Eli Lilly Canada, Inc. to facilitate the withdrawal in Canada. Additional information on the withdrawal will be communicated to hospitals as soon as it is available.
Eli Lilly Canada, Inc. has also issued a news release with information on the withdrawal of Xigris®. Physicians, caregivers or patients with additional questions about Xigris can contact the Lilly Canada Customer Response Centre at 1-888-545-5972.
How to report side effects to health products
To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Adverse Reporting Form and send to us using one of these methods:
- Fax: 1-866-678-6789
- Internet: MedEffect Canada
-
Mail (Canada Vigilance Postage Paid Label):
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9
Related AWRs
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