BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Eli Lilly and Company (LLY) to Withdraw Xigris From Market Worldwide


10/25/2011 7:57:01 AM

OTTAWA, ONTARIO, Oct 25, 2011 (MARKETWIRE via COMTEX) -- 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 ( 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



Read at Fox News
Read at RTT News
Read at BusinessWeek
Read at Washington Post
Read at Reuters

   
Sepsis

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES