VIOXX:HEART AND STROKE WARNINGSep 30, 2004 | www9.sbs.com.au Click here for Free Vioxx Lawsuit Case Evaluation
About 300,000 Australians prescribed the anti-arthritis drug Vioxx have been warned to stop taking the drug and visit a doctor after a clinical trial found an increased risk of heart attack and stroke.
American pharmaceutical company Merck & Co issued a voluntary worldwide recall of the drug Vioxx overnight, which is commonly used for patients with rheumatoid arthritis or osteoarthritis.
The principal medical officer for the Therapeutic Goods Administration John McEwen said that during the past year there were about 3.2 million prescriptions for Vioxx in Australia with about 250,000 to 300,000 people taking the drug.
Vioxx is marketed in more than 80 countries with sales of $A3.5 billion last year.
It was shown to heighten the risk of stroke and heart attack in a study of patients taking the drug in a Merck internal trial to evaluate its effectiveness against colorectal polyps.
Dr McEwen said said the Therapeutic Goods Administration, the medicines regulator, had been monitoring Vioxx for some time.
In October 2003 the TGA published an article in the Australian Adverse Drug Reactions Bulletin alerting Australian doctors to some evidence of increased risk of cardiovascular and cerebrovascular disease with the use of rofecoxib, which appeared to be related to doses greater than 25mg a day.
"As a result of the new evidence, the TGA recommends that patients stop taking Vioxx," Dr McEwen said.
"Patients who stop taking Vioxx can expect some worsening of their symptoms but the rate will be variable,” he warned.
"They should make an appointment to see their doctor to discuss alternative treatment."
Vioxx was first approved in Australia on June 30, 1999, and is currently approved for the symptomatic treatment of rheumatoid arthritis or osteoarthritis at a dose of 25mg a day.