The Marketed Health Products Directorate of Health Canada agrees that comprehensive risk–benefit evaluations should include information from postmarketing surveillance, epidemiologic research and clinical trials. However, in the absence of complete evidence, it is well recognized that spontaneous adverse reaction reports are nonetheless valuable in signalling a potential problem. Our newsletter is meant to provide observational results from the database. The safety of new drugs cannot be known with certainty until a drug has been marketed for many years.1
Although a relation between the cardiovascular findings and the use of rofecoxib and celecoxib has not been established at this time, Health Canada, as a precaution, deems it necessary to inform health professionals and advises patients with a medical history of hypertension, fluid retention or heart failure to discuss their medical condition with their physician. Since the newsletter article,2 “Dear Healthcare Professional” letters, prepared in collaboration with Health Canada and the manufacturers, were issued for rofecoxib and celecoxib on Apr. 15 and May 13, 2002, respectively. Health Canada also released public advisories for these drugs in April and May 2002 (available at www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/advhp_e.html). Ongoing evaluations and expert consultations are being conducted by Health Canada, and any new safety information will be reflected in the product monographs of these drugs.
Ann Sztuke-Fournier Marielle McMorran Editors Canadian Adverse Reaction Newsletter Ottawa, Ont.
References
- 1.Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287(17): 2215-20. [DOI] [PubMed]
- 2.Vu D, Murty M, McMorran M. Selective COX-2 inhibitors: suspected cardiovascular/cerebrovascular adverse reactions. Can Adverse React Newsl 2002;12(2):2-3