Vioxx trial data shows early heart risk

US researchers revealed that the heart complications after taking Vioxx, the nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer Merck pulled the drug from the market.

The research is led by Joseph Ross, MD, MHS, Assistant Professor of Geriatrics and Palliative Medicine and of Medicine at Mount Sinai School of Medicine with a team of six investigators.

Researchers analyzed 30 randomized, placebo-controlled trials of Vioxx that were made available through litigation and published their findings in the 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.

Their analysis showed that safety concerns arose almost four years before the drug was withdrawn from the market. Dr. Ross and his colleagues found that as of December 2000 – when 21 of the 30 studies had been completed – there was a strong concern that patients taking Vioxx were at a greater risk for adverse events or death from cardiovascular conditions or blood clots. Thereafter, collected data through June 2001 showed Vioxx to be associated with a 35 percent increase in risk of a cardiovascular event or death. The association with cardiovascular risk strengthened as more data became available. As of April 2002, the pooled analysis showed a 39 percent increased risk, and as of September 2004, a 43 percent increased risk.

Merck introduced Vioxx to the market in May 1999 and the drug quickly became a commercial success, with sales reaching $2 billion annually.

Source: Mount Sinai School of Medicine, USA



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