Revised: 26 October 2011
Publications
Worldwide withdrawal of Xigris (drotrecogin alfa)
Medsafe has been informed that Xigris is being withdrawn worldwide. This decision has been voluntarily taken by the manufacturer Eli Lilly and is based on the results of the PROWESS-SHOCK study. This study found that Xigris was no better than standard care in preventing patients dying from severe infections.
Medsafe is awaiting further information from Eli Lilly such as what hospitals need to do with any stock they may have. Further information will be provided as soon as it becomes available.
Medsafe recommends that prescribers:
- Do not start Xigris treatment in any new patients.
- Stop Xigris treatment in all patients currently receiving an infusion.
ENDS
Additional information
Xigris was approved for use in New Zealand in 2002 to reduce the risk of death in adult patients with severe sepsis (severe infection associated with acute organ failure, eg kidney, liver or heart failure), who have a high risk of death as determined by APACHE II (I), a scoring system based on the patient's general health and the severity of their illness.
Xigris is only used in specialist areas such as Intensive Care Units and therefore usage is likely to be low in New Zealand.
Xigris is a recombinant human Activated Protein C (APC). APC is produced by the body and has an important role in the body's response to infection. Specifically, APC works by preventing clot formation and helping to dissolve existing clots. It also appears to have some anti-inflammatory effects.
