Withdrawal of Xigris® [drotrecogin alfa (activated)] from the market

Eli Lilly and Company would like to inform healthcare professionals of the worldwide voluntary recall of Xigris® [drotrecogin alfa (activated)] due to new clinical trial findings of lack of efficacy of the product. The recent decision to withdraw Xigris® from the market is based on results from the PROWESS-SHOCK study, where overall 28-day mortality in Xigris®-treated patients (N=846) was 26.4% compared to 24.2% in the placebo control group (N=834); (p=0.31, RR=1.09 [0.92-1.28]). This PROWESS-SHOCK study was conducted as part of an EU regulatory commitment to further evaluate the benefit-risk profile of the drug. While the study showed no survival benefit, no new safety findings were observed. Healthcare professionals are advised to discontinue patients who are currently on Xigris® and to not initiate treatment in new patients.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.