Canada, Europe, India. Pfizer has voluntarily suspended the sale of valdecoxib (Bextra) in the EU countries (1) and in Canada (2), at the request of the respective regulatory agencies. It may be recalled that Pfizer agreed to similar actions in the United States (WHO Pharmaceuticals Newsletter No. 2, 2005). The suspension is effective pending further safety reviews. Health Canada has stated that satisfactory safety evidence needs to be established with respect to the review of cardiovascular, gastro-intestinal and rare but potentially life-threatening skin reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme. Agencies are advising prescribers not to initiate treatment of new patients, to monitor carefully patients being treated with valdecoxib (1) or to switch to alternative therapy, where appropriate (2). Ranbaxy Laboratories in India has voluntarily discontinued sales of its valdecoxib formulations (3). Ranbaxy's decision comes even as valdecoxib is being reviewed by India's Drug Controller General for its benefit/risk profile. Selective COX-2 inhibitors such as celecoxib, parecoxib, valdecoxib and etoricoxib are required to carry a 'precautionary warning' on their labels and promotional literature in India (see WHO Pharmaceuticals Newsletter No. 2, 2005).
1. EMEA statement, EMEA/121637/2005, 7 April 2005 (http://www.emea.eu.int).
2. 'Dear Health-care Professional' letter from Pfizer Canada Inc., 21 April 2005 (http://www.hc-sc.gc.ca).
3. Scrip World Pharmaceutical News No. 3048, 22 April 2005 (http://www.scrippharma.com).