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Vioxx Dangers Should Have Been Known Years Before Recall

Nov 24, 2009 | Parker Waichman LLP

We have long been writing about the links between Merck’s blockbuster nonsteroidal, anti-inflammatory medication Vioxx (rofecoxib) and negative cardiac events. Now, according to Science Daily, a study has found that evidence of cardiovascular risks linked to Vioxx might have been realized almost four years before Merck & Co. Inc., pulled the drug from the market.

Vioxx was approved for use in 1999, and quickly became a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

The Vioxx study detailed by Science Daily was led by Joseph Ross, MD, MHS, Assistant Professor of Geriatrics and Palliative Medicine and of Medicine at Mount Sinai School of Medicine. Dr. Ross led a team of six investigators who analyzed 30 randomized, placebo-controlled trials of Vioxx; the information was available as part of litigation processes and findings were published in the November 23 issue of Archives of Internal Medicine, said Science Daily. Also, according to Science Daily, under recent FDA disclosure requirements, this analysis could be the basis 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, quoted Science Daily. "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," Dr. Ross added.

The team looked at 30 randomized, placebo-controlled trials that enrolled a total of 20,152 individuals, said Science Daily. Trials took from four weeks to four years and assigned a range of 17 to 2,586 participants to take Vioxx in doses from 12.5 to 50 milligrams. The team combined the study data and looked at cumulative results as those results became available.

The research revealed that safety concerns were apparent nearly four years prior to Vioxx’s withdrawal from the market. Dr. Ross and his team learned that as of December 2000—21 of the 30 studies had been completed by this time—there existed significant concerns that patients taking Vioxx were at increased risk for adverse events or death from cardiovascular conditions or blood clots, said Science Daily. Then, information received through June 2001 revealed that Vioxx was linked to a 35-percent increased risk of suffering a cardiovascular event or death. The link with these cardiovascular risks increased as more information was compiled with the combined information revealing a 39 percent increased risk by April 2002 and a 43 percent increased risk by September 2004.

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