Extent of problems caused by withdrawn heart drug revealed

Reported by Susan Aldridge, PhD, medical journalist

The arthritis drug Vioxx may have caused many thousands of cases of heart disease, according to a new study.
Vioxx - or rofecoxib - belongs to a class of drugs known as the COX-2 inhibitors. Like conventional non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, rofecoxib was used to relieve the pain and inflammation of arthritis. It was designed to avoid the common gastro-intestinal complications associated with conventional NSAIDs. However, it was withdrawn from the market in September last year because of a link with heart problems.

Now researchers at the US Food and Drug Administration report on how heart disease risk was increased with standard or high doses of rofecoxib compared to celecoxib (Celebrex), another COX-2 inhibitor, or conventional NSAIDs. Of a group of 1.4 million people in California using the drug, over 8,000 had serious heart disease.

The comparison showed that those on rofecoxib had a 34 per cent higher chance of heart disease than those using other NSAIDs. The risk was higher among those on higher doses. And those on naproxen, a conventional NSAID, had a 14 per cent risk of heart disease compared to other drugs in this class. Previously it's been thought that naproxen protects against heart disease. This means that there would have been 88,000 to 140,000 excess cases of heart disease linked with rofecoxib during the time it was on the market. Further work is now needed to assess the safety of the other COX-2 inhibitors.

Source
The Lancet online 25th January 2005