Following the worldwide withdrawal of Vioxx (rofecoxib), the European Medicines Agency (EMEA) has been asked by the European Commission, as a precautionary measure, to conduct a review of COX-2 inhibitor medicines.
The CHMP, the Agency’s scientific committee responsible for human medicines, will look at all aspects of cardiovascular safety of the COX-2 inhibitors celecoxib, etoricoxib, lumiracoxib, parecoxib and valdecoxib, including thrombotic events (e.g. heart attack and stroke) and cardio-renal events (e.g. hypertension, oedema and cardiac failure).
The CHMP had previously reviewed the COX-2 inhibitor class in 2003, but will now be reviewing newly available data.
The objective of this review is to assess whether there is a need to make changes to existing marketing authorisations including labelling throughout the whole of the European Union and whether additional studies are needed.
The outcome of the review will be posted on the Agency’s web site once the Committee has reached its conclusion. Meantime, the information to prescribers and patients issued by the EMEA on 6 October 2004 remains valid:
Information to prescribers: