Xigris 5 mg and 20 mg recall due to risk/benefit concerns

(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

MDR 46-10/11

Product information

Eli Lilly and Co Ltd

Xigris 5 mg and 20 mg - Powder for solution for infusion

Drotrecogin alfa (activated)

EU/1/02/225/001-002

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.

MHRA distribution

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
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary care trusts (England)

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