11 Oct 2004

Withdrawal of Rofecoxib

The NSAID Rofecoxib is mentioned in Section 4.2.4 and Annex 10 of this guideline. This drug has been voluntarily withdrawn from the market by the manufacturers due to concerns about a possible increased risk of heart attack or stroke. Patients currently being prescribed Rofecoxib should be transferred to a suitable alternative NSAID. Further information about the reasons for withdrawal of the drug can be found on the US Federal Drug Administration Web site at http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx