Xigris 5 mg and 20 mg recall due to risk/benefit concerns
- Medicines and Healthcare products Regulatory Agency
- 26 October 2011
- Alert type:
- Drug alert
- Medical specialism:
(Eli Lilly) Recall following clinical trial findings showing lack of efficacy and risk/benefit concerns – class 1 action now. (EL (14)A/15)
26 October 2011
Class 1 medicines recall
For immediate action
Recall to hospital and wholesaler level
Eli Lilly and Co Ltd
Xigris 5 mg and 20 mg - Powder for solution for infusion
Drotrecogin alfa (activated)
Immediate withdrawal of all distributed stock
Eli Lilly has informed us that all distributed stock of Xigris is being recalled following discussions with the European Medicines Agency. This action is being taken following new clinical trial findings which show a lack of efficacy and call into question the risk-benefit profile of the product. Specifically, this relates to the 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]).
Patients currently being treated with Xigris should have treatment discontinued. No new patient treatment should be initiated. For further medical information please call Eli Lilly Medical Information on 01256 315000.
Suspected adverse reactions should be reported to the MHRA by use of a Yellow Card, which is available from MHRA, Freepost Yellow Card or electronically via http://www.mhra.gov.uk/yellowcard
Any unused stock should be returned to the original supplier for credit. For enquiries related to product returns please call 0800 012 1178.
Recipients of this drug alert are requested to forward this to recipients listed in the central title at the start of the document as promptly as possible. We understand this is a hospital-only product not likely to be used by community pharmacists or general practitioners.
Further recipients by cascade:
Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Healthcare Commission for distribution to Independent Health Care Establishments
Primary care trusts (England)
Issued: 26 October 2011
Alert type: Drug alert
Medical specialism: Pharmacy