Vioxx Heart Risks Long-LastingOct 14, 2008 | Parker Waichman LLP
Heart risks from Vioxx, the defective painkiller pulled from the market in 2004, lingered long after many patients stopped taking the drug. According to a report in The Washington Post, a study conducted by researchers at the M.D. Anderson Cancer Center in Houston, TX found that Vioxx increased the risk of heart attack and stroke by "close to twofold, and the risk persisted for approximately a year".
The authors of the study, which was published online by the journal Lancet, also believe that long-term use of other NSAIDs, including now-banned Bextra, as well as Celebrex, and over-the-counter versions of ibuprofen and naproxen, increase stroke and heart attack risks to some extent.
Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market 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 recall led to thousands of lawsuits.
This latest Vioxx study involved followed people who had participated in the international APPROVe trial, which compared Vioxx to placebo over 3 years in an attempt to see whether the drug could cut the recurrence of cancerous colon polyps. The trial was stopped early in 2004 because of the increased risk for heart attacks and stroke. Nearly 2600 people participated in the APPROVe trial, and the authors of the Lancet study said they were able to contact about 84 percent of them.
According to the study, former Vioxx users still had a 79 percent increased risk of heart attack, stroke or death compared with those who had received placebo. Individual patients faced double the risk of heart attack or stroke in the year after stopping the drug. The increased risk of dying was 31 percent compared with those who had taken placebo, the researchers noted.
Co-author of the study, Dr. Robert Bresalier, told the Washington Post that it is probable that all non-aspirin NSAIDs can increase the risk of cardiovascular problems. "Similar data has been evident for some of the other cox-2 inhibitors," Bresalier said. "In fact, it seems to be a class effect for most if not all NSAIDs."
Bresalier said that certain patients - those with pre-existing cardiac problems - should avoid long-term use of these drugs. However, the risk is small when NSAIDS are taken for short periods of time for intermittent pain relief.