Study: Vioxx Risk Lingered After Discontinued Use

When Vioxx was taken off the market in 2004, due to concerns that it increased the risk of heart attack, stroke and death – many were under the assumption that discontinuing use would end the associated health risks.

But, now, a new study suggests that the “risks increased nearly twofold, and persisted for a year or more after stopping use of Vioxx,” said Dr. Robert Bresalier, co-author and professor of medicine at the M.D. Anderson Cancer Center in Houston, Texas.

“The upside is, the data suggests the risk does not last and goes back toward normal after a year,” he said.

Another issue raised by this analysis was how soon the risk started after beginning to use Vioxx.

Several doctors, long critical of Merck and its reporting of Vioxx studies, have contended that increased cardiovascular risks started within just a few months of use and persisted after discontinuing use.

Researchers and many experts believe long-term use of most non-aspirin pain killers in the same drug class – also known as non-steroidal anti-inflammatory drugs (NSAIDs) such as Aleve/Naproxen – also increases the risk of heart attack stroke and death to a certain extent.

Merck continues to argue that cardiac risks did not increase until after 18 months or more of use – a basis of its approach to fight thousands of pending lawsuits filed by people claiming they have suffered harm by Vioxx.

The study is published in October 14 early online edition of The Lancet.

Last year, Merck inked a $4.85 billion deal to settle thousands of claims for strokes, heart attacks and deaths allegedly caused by the drug.

The “APPROVe” study was intended to show that Vioxx, promoted as a pain reliever with lower gastrointestinal risks than other anti-inflammatory drugs, could prevent the recurrence of colon cancer.

Merck halted the study early and withdrew the drug from the market on September 30, 2004, when data showed a double risk of cardiovascular complications and death in the group of patients taking Vioxx, over those taking a placebo.

In the year after the 2,487 patient-study was discontinued, eight researchers found – 34 people taking the drug and 18 taking a placebo suffered a heart attack – a 94 percent greater risk in Vioxx users.

19 Vioxx users suffered a stroke compared to nine people on placebo, for a risk slightly more than double. In total, 76 Vioxx users and 46 placebo users suffered a stroke, heart attack, blood clot or death during that follow-up year.

The increased complications are nearly the same as the findings during the three-year trial and the first two weeks after the study was first halted.

Merck came under fire after publishing its first analysis from the APPROVe Study, in 2005. The company later admitted to using the wrong statistical methods of analysis and the editors of the New England Journal published a correction in 2006 stating the risk of heart problems was increased throughout the duration of time people were taking the drug.

The analysis helps to further establish not only the risk of Vioxx, but the temporal duration,” said Dr. Eric J. Topol, director of the Scripps Translational Science Institute. “We now have compelling data that the risk extends a year after stopping the drug,” he said.

However, Dr. Topol, one of the first to raise concerns about Vioxx, is unsure that this is a class effect of all cox-2 inhibitors.

In other Vioxx news, eight states, along with Florida, are suing Merck & Co alleging deceptive marketing of the recalled painkiller Vioxx.

Florida’s Attorney General Bill McCollum says the state wants to be reimbursed for more than $80 million spent on health programs, such as Florida’s Medicaid program, which included Vioxx as an approved drug. Patients taking it for pain would be reimbursed for the prescription. #