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Vioxx, made by Merck & Co, was one of the most heavily-promoted prescription drugs for patients with arthritis, bringing in sales worth £1.4 billion a year. The Department of Health has contacted every GP in the country to advise that the drug has been withdrawn and that patients should be put on alternative medication. However, it said there was no need for patients to stop taking the drug before seeing their doctor.
“We are emphasising that patients do not need to take immediate action,” a spokeswoman said. “They should try to see their doctors in the next few weeks to discuss what to do.”
Vioxx belongs to a class of drugs designed to control the symptoms of arthritis without the damaging side-effects of older drugs such as ibuprofen.
Merck said a three-year colon cancer study confirmed long-standing worries that the drug raised the risk of heart attack and stroke. The study found that risk increased after 18 months of treatment in the patients taking Vioxx compared to those taking a placebo, Merck said.
The trial, involving 3,000 people, investigated whether Vioxx could prevent the recurrence of polyps — pre-cancerous growths — in patients with a history of colorectal cancer.
For the first 18 months there was no perceptible difference in the rate of heart attacks or strokes between the Vioxx and control groups, but then the two diverged. By last week, there had been 45 heart attacks or strokes in the Vioxx group, and 25 in the placebo group.
The results followed similar findings from a study by the US Food and Drug Administration that suggested patients taking Vioxx faced a 50 per cent greater risk of heart attacks and sudden cardiac death than those taking a rival drug, Celebrex.
It showed that at higher doses Vioxx is more than three times as likely to cause sudden cardiac death or acute heart attack as is ibuprofen. No studies have been carried out into any residual long-term risk to patients who stop taking Vioxx.
Merck withdrew Vioxx voluntarily and with immediate effect. The drug has been marketed in more than 80 countries. The company advised those taking Vioxx to discuss with their doctors an alternative. The most obvious is Celebrex, made by Pfizer, which works in the same way but in trials has not shown the same side effects.
The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday advised patients to contact their doctor by phone or at the next convenient appointment. The Department of Health has briefed NHS Direct how to respond to calls from anxious patients, and e-mailed family doctors with the advice from the MHRA.
Mayur Lakhani, chair-elect of the Royal College of General Practitioners, said: “There is no cause for alarm but if people are worried we would advise them to stop taking Vioxx and use a safer painkiller, which their local pharmacist will be able to advise them on. The next step is to make a routine appointment with their GP to arrange an alternative prescription.”
Pfizer said that it had no doubt that it could meet any surge in demand for Celebrex.
The decision to withdraw Vioxx wiped more than £14 billion off Merck’s stock market value, equivalent to a quarter of the drug giant’s entire worth, and dragged the share price down to an eight-year low.
The announcement also unnerved dealers on the Stock Exchange where shares in AstraZeneca were marked down 13p to £22.65p and those of GlaxoSmithKline (GSK) fell 18p to £11.91.
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