Vioxx deaths estimated at 140,000

The online version of the Lancet has published a study that says that the arthritis drug Vioxx could have caused up to 140,000 cases of coronary heart disease in the US since it was launched in 1999.

The US Food and Drug Administration study analysed data from 1.4 million people in California who had used either Vioxx, Celecoxib (Celebrex) which is from the same group of drugs, or other non-steroidal anti-inflammatory drugs (NSAID’s) between 1999 and September last year. 40,000 had used Celecoxib, just under a million had used ibuprofen, 435,000 naproxen and 27,000 Vioxx.

The researchers found that 8,143 had serious heart disease. 1,508 of whom had sudden cardiac death.

Then the researchers looked at the risk of heart problems linked to each drug, and they found that the people who had been taking Vioxx had a 34% high chance of coronary heart disease when compared to people taking other NSAID’s.

Coronary heart disease was 1.6 times higher among poeple taking standard dose Vioxx compared to those taking Celecoxib and 3.6 times more likely among those taking a higher dose.

Lead researcher Dr David Graham, from the FDA’s Office of Drug Safety, said: “While this report was in preparation, Rofecoxib (Vioxx) was withdrawn from the market by the manufacturer. we should assess the potential public health effects of failure to take earlier action. In the future, when trials show that a new treatment confers a freater risk of a serious adverse effect than a standard treatment, we must be much more careful about allowing its unrestrained use.”

The Lancet says that Vioxx should have been withdrawn from the market four years ago as there was enough evidence then to link the drug to increased risk of strokes and heart attacks. But manufacturers Merck have posted a scientific critique on its website disputing this.

Merck said it posted the item on its website “to further clarify for the scientific community why Merck disagrees with the conclusions” of The Lancet.