FDA Researchers Estimate Vioxx Heart Risk

Food and Drug Administration research released Monday finds Vioxx might have caused 88,000-140,000 U.S. cases of serious coronary heart disease.

The study was published in the online edition of The Lancet. It covered from 1999, when Vioxx came on the market, to September when it was pulled after a clinical trial showed patients taking it longer than 18 months doubled their risk of a heart attack.

The researchers compared heart disease risk with high or standard doses of Vioxx (rofecoxib) to Celebrex (celecoxib) — both cyclo-oxygenase 2 or COX-2 inhibitors — and other nonsteroidal anti-inflammatory drugs, such as ibuprofen and naproxen.

The estimate was extrapolated from data on 1.4 million people in California who had used NSAIDs during the time Vioxx was on the market. It found 8,143 people had serious coronary heart disease, of which 1,508 had sudden cardiac death.

People taking Vioxx had a 34 percent higher chance of coronary heart disease compared with people who used other NSAIDs. The risk was 1.6 times higher for those taking the standard dose of Vioxx compared to those taking Celebrex, and 3.6 times greater for those using higher doses of Vioxx.

People taking naproxen had a 14 percent increased risk of coronary heart disease compared with other NSAIDs.