Further to the 7 April, 2005 statement on the suspension of use of Bextra (valdecoxib), the Committee for Medicinal Products for Human Use (CHMP) of the EMEA held a hearing with Pfizer and reviewed data on serious skin reactions occurring with valdecoxib and its parent compound parecoxib (Dynastat).
The Committee discussed the preliminary information provided and agreed that this raised questions for all Cox-2 inhibitors. The Committee agreed that it was important to analyze the occurrence of skin reactions in order to arrive at a conclusion on the benefit-risk balance of the Cox-2 class of medicines.
The European Commission (EC) has now formally asked the CHMP to include the assessment of serious skin reactions in the ongoing class review, in addition to the cardiovascular safety aspects.
Further hearings will be held with the companies in May, with the review expected to be concluded in June. Pending the finalization of the review, it was agreed that Bextra will not be reintroduced on the market in the European Union.