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 ( https://investor.lilly.com/releasedetail2.cfm?ReleaseID=617647 ) with information on the recall. Physicians, caregivers or patients with additional questions about Xigris can contact the company directly at 1-800-LillyRx (1-800-545-5979) or www.Xigris.com .
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 Reporting Form ( http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php ) and send to us using one of these methods:
Fax: 1-866-678-6789
Internet: www.healthcanada.gc.ca/medeffect
Mail (Get a postage-paid label ( http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php )):
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
SOURCE: Health Canada
