Vioxx may have killed thousands of UK patients, study warns

By Times Online and PA News

January 25, 2005 - An arthritis drug withdrawn on safety grounds last year probably killed tens of thousands of patients in Britain and America, a study suggested today. Researchers said the drug Vioxx may have caused between 88,000 and 140,000 serious heart problems in the United States alone since its introduction in 1999.

As 44 per cent of American patients with heart disease go on to die of the condition, many of the Vioxx patients were likely to have had their deaths hastened by the drug, it was claimed.

Vioxx, which has the scientific name rofecoxib, was also prescribed to 400,000 patients in the UK. It was taken off the market at the end of September after a three year trial linked it to an increased risk of heart disease events. The study published on-line today by the Lancet medical journal analysed data from 1.4 million Californians who had used various kinds of non-steroidal anti-inflammatory drugs (NSAIDs).

Among them were 27,000 patients who had been taking Vioxx, which belongs to a family of drugs known as Cox-2 inhibitors. A total of 40,000 were given another Cox-2 inhibitor, Celebrex, while others were taking ibuprofen or naproxen.

The investigators, led by David Graham from the US Food and Drug Administration’s Office of Drug Safety, found that 8,143 had suffered from serious heart disease between 1999 and last September. Of these, 1,508 died suddenly from a heart problem. People given Vioxx had 34 per cent higher chance of heart disease when compared with patients taking one of the other drugs.

Heart disease was 1.6 times more likely among those taking standard-dose Vioxx compared with those prescribed Celebrex. For patients on high doses, the risk was 3.6 times greater. The study also found that people taking naproxen had a 14 per cent increased risk of heart disease than those on other painkillers. This was a surprise, since previous studies have suggested that naproxen protects against heart disease. Dr Graham said: "An estimated 88,000-140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of rofecoxib.

The US national estimate of the case-fatality rate (fatal heart attack plus sudden cardiac death) was 44 per cent, which suggests that many of the excess cases attributable to rofecoxib use were fatal. "In the future, when trials show that a new treatment confers a greater risk of a serious adverse effect than a standard treatment, we must be much more careful about allowing its unrestrained use."


In an accompanying commentary, Simon Maxwell and David Webb, from the University of Edinburgh said attention would now focus on the safety of other Cox-2 inhibitors. Concern has already been raised about Celebrex, which has been linked to a doubling of the risk of heart attack and strokes.

Prof Webb said: "It now falls to the manufacturers, under the careful review of the regulatory authorities, to provide all the evidence that this class of drugs is safe, if necessary including studies that directly address cardiovascular morbidity as a primary outcome." He said the lessons learned from Cox inhibitors underlined the need for full publication of all clinical trial data on newly licensed drugs.

However evidence calling into question the safety of Cox-2 inhibitors was contradicted by a separate observational study of more than 6,000 patients also published today. It indicated that Cox-2 inhibitors were not more risky than other NSAID painkillers. Overall, 12 per cent of the patients had at least one blood-clotting event after treatment, said the researchers led by Dr Fadia Shaya from the University of Maryland in Baltimore, USA. Users of naproxen were excluded from the study.

The scientists wrote in the journal Archives of Internal Medicine: "The results of this analysis do not show a difference in the rate of cardiovascular events between Cox-2 inhibitors and non-naproxen NSAIDs. "Given that the study population had higher baseline cardiovascular risk, these observations provide more confidence that the widespread use of Cox-2 inhibitors will not be associated with an increase in thrombotic or coronary artery events."

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