Vioxx Trial Data Shows Early Cardiovascular Risk, Provides Lessons for Post-Market Pharmaceutical Safety

Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.

Led by Joseph Ross, MD, MHS, Assistant Professor of Geriatrics and Palliative Medicine and of Medicine at Mount Sinai School of Medicine, a team of six investigators analyzed 30 randomized, placebo-controlled trials of Vioxx that were made available through litigation and published their findings in the November 23 issue of Archives of Internal Medicine. Under new FDA disclosure requirements, the analysis may also serve as a blueprint for other independent post-market pharmaceutical safety studies.

“Independent, objective investigators can play a more active role in pharmaceutical safety surveillance, ideally in concert with the FDA and industry,” said Dr. Ross. “Our study is an analytic approach that can be used to inform public health efforts. Comprehensive, rigorous analysis of clinical trial data allows the earlier identification of drug risks, promoting more informed treatment decisions, protecting the public’s health, and perhaps saving lives.”

Read more…..

Comments

Comments are closed.