Study confirms Vioxx’s links to increased cardiovascular risks

Chicago, October 14: It has been almost four years since the signature arthritis drug, Vioxx, was pulled from the market in 2004 over concerns that it increased the risk of heart attack, stroke and death. Though until now, the manufacturer, Merck and Co., had maintained that the drug was free from such accusations, results of a long-term analysis have proved otherwise.

The drug, in fact, doubles the risk of strokes and heart attacks in those taking prescription drug, but this risk goes away a year after they stop taking it, the results show.

"The good news is the data suggests that the risk doesn't persist forever. The risk goes back toward normal after a year of follow up," Dr. Robert Bresalier, Professor of medicine at the M.D. Anderson Cancerdefine Center in Houston noted.

Interestingly, the long-term use of all such drugs - non-aspirin painkiller drugs also called the non-steroidal anti-inflammatory drugs (NSAIDs) - boosts the users' risks of heart attack, stroke and death to some degree, the researchers of the study confirmed.

Designed to target the cyclooxygenase 2 (cox-2) enzyme involved in inflammation, the NSAID drug family include popular prescriptions Vioxx, Bextra, Celebrex, Ibuprofen (Advil, Motrin) and Naproxen (Aleve).

The new study led by Dr. Bresalier included over 2,100 patients who had originally participated in the international APPROVe trial.

The 3-year international APPROVe trial conducted to check whether the drug could cut the recurrence of cancerous colondefine polyps was stopped mid-way in 2004 over concerns of increased risk for heart attacks and stroke among study subjects.

Latest follow-up of the 2,100 patients revealed that ex-Vioxx-users still had a 79 percent increased risk of heart attack, stroke or death compared with those who had received placebo.

Also, ex-Vioxx-users stood a 31 percent increased risk of dying compared to those on placebos, the researchers noted.

Moreover, contrary to initial claims wherein Merck maintained that cardiacdefine risks didn't increase until people took Vioxx for about 18 months, latest results reveal that the cardiovascular risks from the arthritis drug started after just a few months' use and persisted even after the use ended.

However, despite the results researchers maintain that one should not stop taking such drugs. "You shouldn’t be afraid to take these drugs if you need them," Bresalier advised. "Instead, speak to your doctor to understand the relative risks and benefits" he added.

The results of the long-term trail are published online in the October 14 issue of the journal ‘The Lancet’.