Major arthritis drug withdrawn after sudden death fears
01/01/2000
Thank you to everyone involved in my case. I never dreamed of such an outcome and you have made such a long and difficult case seem easy and bearable.
Nigel, DerbyshireBY NIGEL HAWKES, HEALTH EDITOR
A blockbuster drug taken by 400,000 people in the UK has been withdrawn from the market after evidence emerged that it more then tripled the risk of heart attacks and sudden death.
Vioxx, made by Merck & Co, the second-largest US pharmaceuticals company, was one of the most heavily-promoted drugs for patients with arthritis, bringing in sales worth $2.5 billion a year.
It belongs to a class of drugs, called coxibs or COX2 inhibitors, designed to control the symptoms of the disease without the damaging side-effects of older drugs such as ibuprofen.
But today Merck said that it was withdrawing the drug in the light of a three-years colon cancer study that confirmed long-standing worries that the drug raised the risk of heart attack and stroke.
"In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo," Merck said.
The results closely matched those of a study by the US Food and Drug Administration this year that suggested patients taking Vioxx faced a 50 per cent greater risk of heart attacks and sudden cardiac death than those taking the rival drug, Celebrex.
At higher doses, the study showed, Vioxx is 3.15 times more likely to cause sudden cardiac death or acute heart attack than is the older drug ibuprofen.
The study also showed that Celebrex does not have this side effect. Patients taking Celebrex were less likely to have a heart attack than those on ibuprofen.
Merck bowed to the results by voluntarily withdrawing Vioxx with immediate effect. The drug has been marketed in more than 80 countries.
"We are taking this action because we believe it best serves the interests of patients," said Raymond Gilmartin, chairman of Merck.
"Although we believe it would have been possible to continue to market Vioxx with labelling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."
The company advised those who have been prescribed Vioxx to discuss with their doctors what alternative they might now take. The most obvious alternative is Celebrex, made by Pfizer.
Merck shares fell sharply in pre-opening trading, and were at one point down $12.01, or 27 per cent, to $33.06, wiping $25 billion off the company's value.
The FDA data was collected by a team from the US Food and Drug Administration, from the medical records of 1.4 million people insured by Kaiser Permanente, the California-based health maintenance organisation.
Dr David Graham, lead investigator for the trial, said at the time that another major finding was that patients taking the typical starting dose of Vioxx had a 50 per cent greater chance of heart attack and sudden cardiac death than patients taking any dose of Celebrex.
"Based upon the evidence in this study, I don't think doctors should prescribe high-dosage Vioxx, and patients shouldn't take it," he said.
The absolute risk of a heart attack or sudden death was still low. In the 27,000 patients using Vioxx, only 68 suffered heart attacks or sudden cardiac death.
When the results were published, the company continued to insist that the drug was safe. But the subsequent confirmation from the colon cancer trial proved too much, especially as in that case a lower, 25 mg dose of the drug was used.
Merck has taken its decision for two reasons. Given a choice between Vioxx and Celebrex, few doctors except those who do not read would now continue to prescribe Vioxx.
The second is that Merck has a new coxib, Arcoxia, already on sale in 47 countries but still waiting for approval from the FDA in the US. The fear that Vioxx would cast a cloud over Arcoxia must also have been an influence.
It may still do so. The FDA said today that it will closely watch coxibs for any signs they might raise the risk of serious heart problems.
Vioxx's fall from grace shows that even the best-designed drugs can have an Achilles' heel. Coxibs were based on elegant scientific work that showed that drugs traditionally used to treat arthritis had an unwanted side-effect because they suppressed two enzymes at the same time.
One of these, COX-1, was key to the control of acid in the stomach. By suppressing it, drugs called non-steroidal anti-inflammatory drugs (NSAIDs) - which include ibuprofen - could cause ulcers or stomach bleeding.
COX-2 inhibitors were designed to avoid this by suppressing only one of the enzymes. The hope was that they would prove safer. In general, this has turned out to be true. But some, clearly, are safer than others.
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