Immediate voluntary world-wide withdrawal of Vioxx (rofecoxib)

Oct 4 2004

Pharmaceutical company, Merck Sharp & Dohme has announced an immediate voluntary world-wide withdrawal of the drug, Vioxx (rofecoxib), commonly used for patients with rheumatoid or osteoarthritis.

The company's decision is based on new information from a recent clinical study called APPROVe which showed that there was an increased risk of cardiovascular events such as heart attack and stroke beginning after 18 months of treatment, in the patients taking Vioxx at a dose of 25 mg once daily.

Compared with taking a placebo, there was one extra of these sorts of events for each 65 patients who took Vioxx for at least 18 months. In the study the fatality rate was not increased in those taking Vioxx.

As a consequence of these results, Merck Sharp & Dohme notified the Therapeutic Goods Administration that it is recalling the drug.

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Vioxx was first approved in Australia on 30 June 1999, and is currently approved for the symptomatic treatment of osteoarthritis and rheumatoid arthritis at a dose of 25 mg a day.

Over the past year, there were about 3.2 million prescriptions for Vioxx with about 250,000 to 300,000 people taking Vioxx in Australia over the course of the year.

Principal Medical Officer for the TGA, Dr John McEwen, said today that the medicines regulator had been monitoring Vioxx for some time and, in October 2003, 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 25 mg 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. They should make an appointment to see their doctor to discuss alternative treatment."

The APPROVe study was designed to evaluate the efficacy of Vioxx in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas (benign tumours of the large bowel).

http://www.tga.gov.au/