Drug company Merck has removed its arthritis painkiller Vioxx because of data showing an increased risk of heart attack and stroke.
Patients currently taking the drug should contact their doctor to discuss stopping and switching to alternative treatments, experts said. A three-year trial showed an increased risk of cardiovascular events began after 18 months of Vioxx treatment. Vioxx is used by two million people around the world. In the UK, it has been available since 1999 and is used by 400,000 people. US regulator the Food and Drug Administration said it would closely watch drugs in the same class as Vioxx (rofecoxib) for any signs they might raise the risk of serious heart problems. These are known as cyclooxygenase-2 or COX-2 Inhibitors, which are more ‘stomach friendly’ alternatives to traditional pain relief drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Strokes and heart attacks Following a number of adverse reports after Vioxx became available in the UK in 1999, the European Committee for Proprietary Medicinal Products looked into the safety of COX-2 drugs. In 2003, it concluded that the balance of risks and benefits of the products remained positive. But it recommended strengthening existing warnings about use in patients with underlying cardiovascular risks. Merck’s chairman Raymond Gilmartin said: “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.” RCGP chair elect Mayur Lakhani said: “There is no cause for alarm but if people are worried we would advise them to stop taking Vioxx and use a safer pain-killer, which their local pharmacist will be able to advise them on. Advice “The next step is to make a routine appointment with their GP to arrange an alternative prescription. “Patients should be re-assured that there are several other treatments available for arthritic pain relief.” Chairman of the medicines watchdog the Medicines and Healthcare Regulatory Agency, Professor Sir Alasdair Breckenridge, echoed this advice. A spokeswoman from the Arthritis Research Campaign said: “This is a highly unprecedented move. “There had been doubts about Vioxx’s safety in terms of cardiovascular risk. “There is no such thing as a drug without side effects, but the risks must have been too high.” But she did not think other COX-2 drugs would carry the same risk.(Source: BBC News: October 2004.)