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Arthritis drug removed for safety
DRUG company Merck has removed its arthritis painkiller Vioxx because of data showing an increased risk of heart attack and stroke.
The drug is used by up to two million people around the world.
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.
Merck's decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe trial.
The trial was stopped early because there was an increased risk of serious cardiovascular events, such as heart attack and stroke, after 18 months of continuous treatment with Vioxx.
The APPROVe trial was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of cardiovascular events from taking Vioxx.
The FDA originally approved Vioxx in May 1999. The original safety data included approximately 5,000 patients taking Vioxx and did not show an increased risk of heart attack or stroke.
A later study, VIGOR, was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000.
The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking the over-the-counter drug naproxen.
However, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee, and the new safety information from this study was added to the labeling for Vioxx in April 2002.
Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with long-term use of Vioxx.
In the UK, it has been available since 1999 and is used by an estimated 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).
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.
"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.
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