No Vioxx-linked cardiac problems reported

There have been no reported cases of cardiac problems related to the use of the breakthrough arthritis drug Vioxx (rofecoxib) in Malta, the Medicines Regulatory Unit's post-licensing director John Borg said.

The unit had only received reports of an adverse drug reaction connected to Vioxx last year and Dr Borg said this was not related to cardiac problems and was resolved without any complications.

About 800 prescriptions for Vioxx a month were issued in Malta, a source at A.M. Mangion Ltd, the local importer, said. Vioxx was sold in 80 countries and used by about 80 million patients.

The dug was voluntarily withdrawn from the global market, including in Malta, last September by manufacturer Merck & Co following a three-year study which showed that there was an increased relative risk of cardiovascular problems - such as heart attack and stroke - after 18 months of treatment. A group of patients taking a 25 milligram daily dose of the drug were found to have four times the chance of cardiac problems than the placebo group.

"We can conclude that rofecoxib does have adverse cardiovascular effects, that these are dose-related and manifest in early months of use and that this effect could have been predicted with confidence three years ago," a commentary in the medical journal The Lancet said.

A new study published last week on the same journal said the use of Vioxx - an arthritis and acute pain medication - increased the risk of serious coronary heart disease when compared to another similar drug, celecoxib.

When contacted, Dr Borg said the drug was withdrawn from the market by a decision that was independent of the Medicines Authority. Following the withdrawal, the authority has been actively participating in a holistic class review of Cox2 inhibitors - the class of medicines Vioxx belongs to - which is being carried out by the European Medicines Agency's Committee for Medicinal Products For Human Use. The committee, made up of over 50 medicines experts, is assessing the associated health risk and benefit of a number of medicines.

Dr Borg said the committee was expected to continue its discussions at its next meeting later this month and should reach a final decision and recommendation on the licensing of the medicines by next month.

"Following the committee decision on these medicines, all EU member states will execute any recommendations made in a pan-European approach," he said.