Study Finds Vioxx Risks Lasted After End of Use


A study whose findings have been published online in The Lancet, a UK medical journal, shows that users of Vioxx faced an increased risk of heart attack, stroke and death for up to a year after they quit taking the drug. It was assumed that Vioxx users would be safe after the drug was pulled from the shelves in 2004. Co-author of the study, Dr. Robert Bresalier, says that the good news is that the risk seems to have diminished after one year.

Bresalier and other researchers followed individuals who were involved in the international APPROVe trial, which looked at Vioxx and a placebo over a three year period. The study attempted to find out whether Vioxx could lessen the occurrence or recurrence of cancerous polyps in the colon. This trial was ended in early 2004 due to the increased risks associated with Vioxx.

The new study covers 84 percent of those who were part of the original trial. Researchers found that nearly 79 percent of those individuals were still at increased risks a year after the drug trial ended. This is congruent with the risk found during the trial, in which those who took Vioxx were twice as likely to have a heart attack or stroke as those who were not taking the drug. The risk of dying increased by 31 percent over those taking the placebo.

Researchers of the study and other experts believe that long-term use of non-aspirin painkilling drugs in the same category as Vioxx increase the risk of heart attack, stroke, and death across the board. These drugs, called non-steroidal anti-inflammatory drugs (NSAIDs), also include cox-2 inhibitor drugs (cox-2 drugs target the cyclooxygenase 2 enzyme which is involved in inflammation, such as Vioxx and Bextra, as well as Celebrex.

Though Celebrex is the only one of these three still on the market, it is unknown if Celebrex is more likely to increase risks than are other cox-2 drugs. However, Dr. Eric J. Topol, director of the Scripps Translational Science Institute and Chief Academic Officer of Scripps Health, says one needs to be suspicious of Celebrex. He claims Celebrex taken in high doses increases the risk of heart attack and stroke, but that no studies have been done to show its long lasting effects.

Merck, the manufacturer of Vioxx, issued a statement, claiming the pharmaceutical company believes this analysis is “post hoc,” and uses limited data from a “prematurely terminated study.” This is obviously in response to the many lawsuits the company already faces and will likely face in the future for their defective drug.