Safety fears over arthritis drugs

A worldwide study involving 2,000 patients found rofecoxib "substantially" increased the chances of dying or suffering a non-fatal stroke or heart attack even a year after stopping treatment.

Sold under the brand name Vioxx, the drug was dramatically withdrawn from the world market in 2004 by manufacturers Merck & Co after research showed it doubled the risk of heart attacks.

The Merck-funded research published in an early online edition of The Lancet medical journal followed up the original study that led to the Vioxx scare.

A total of 2,587 patients took part in the APPROVe (Adenomatous Polyp Prevention On Vioxx) study which looked at whether Vioxx could reduce the risk of bowel polyps. The trial was stopped early in September 2004 when the increased risk of cardiovascular events linked to Vioxx was discovered.

The new study looked back at the progress of around 2,000 of these patients for a year after they ceased taking the drug. Participants in APPROVe were randomly assigned either to be treated with Vioxx or to receive a dummy placebo drug.

After the follow up, it was found that the risk of death or non-fatal heart attacks or strokes was 79% higher in the Vioxx group than the placebo group.

Over the 12-month period after treatment was stopped, Vioxx patients had twice the risk of heart attack or stroke of those who took the placebo. Their relative risk of death was 31% higher.

A spokeswoman for the Medicines and Healthcare Products Regulatory Agency (MHRA), which licences medical treatments, said: "The MHRA will carefully review the latest evidence relating to the safety of this important class of medicines, and will seek advice from the Commission on Human Medicines if necessary. The ideal anti-inflammatory prescribing choice will vary from patient to patient, depending on individual risk factors, therapeutic response and patient preference. Prescribers need to weigh up all the risks (of which gastrointestinal and cardiovascular are the most important).

"Patients should use the lowest effective dose, and the shortest duration of therapy necessary to control symptoms. Adherence to these principles should ensure that the risks are minimised, and for the vast majority of patients the overall risks are outweighed by the benefits of anti-inflammatory treatment. Any patient who is concerned about their current anti-inflammatory treatment should speak to their pharmacist, doctor or nurse at their next routine appointment."