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Volume 488: debated on Monday 23 February 2009

To ask the Secretary of State for Health what discussions (a) he, (b) Ministers in his Department and (c) officials in his Department have had since June 2008 with the US Administration on the drug Vioxx; and if he will make a statement. (256528)

Neither Ministers nor officials in the Department have held any discussions with the United States Administration on this matter.

To ask the Secretary of State for Health what estimate he has made of the cost to the NHS of treating those with health impairments resulting from the use of Vioxx in the last 12 months; and if he will make a statement. (256531)

To ask the Secretary of State for Health what estimate he has made of the number of people who have experienced strokes related to their use of the drug Vioxx. (256532)

Vioxx (rofecoxib) was one of a relatively new group of anti-inflammatory medicines known as COX-2 selective inhibitors. It was licensed in the United Kingdom and many other countries for the treatment of arthritic conditions - osteoarthritis and rheumatoid arthritis—and also for the short-term treatment of some painful conditions. COX-2 selective inhibitors are effective anti-inflammatory, pain-relieving medicines that are thought to have less risk of gastrointestinal side effects, for example stomach ulcers, than conventional anti-inflammatory medicines.

Since 2000, evidence from clinical trials had raised concerns about a possible increased risk of heart attacks and other cardiovascular conditions associated with Vioxx, and the Medicines and Healthcare products Regulatory Agency (MHRA)/Committee on Safety of Medicines (CSM) had continually reviewed the cardiovascular safety of this drug since it was first licensed. The product information for healthcare professionals and patients, which lists all the known side effects of the medicine, was updated on a number of occasions on the basis of emerging evidence, and in accordance with CSM’s advice.

Data are not available on which to base a valid estimate of the number of heart attacks, strokes and other adverse effects that may have been caused by Vioxx and other COX-2 inhibitors. The underlying medical condition of many patients treated with COX-2 inhibitors means that they are already at higher risk of heart attack and stroke than the rest of the population, and the impact of the COX-2 inhibitor on this risk is not possible to calculate.

Since Vioxx was voluntarily withdrawn by the manufacturer in 2004, the safety of other COX-2 inhibitors and traditional anti-inflammatory drugs—non-selective non-steroidal anti-inflammatory drugs (NSAIDs)—has been under continual and intense assessment in the UK and Europe. The latest evidence suggests that both NSAIDs and COX-2 inhibitors might pose a small increased risk of heart attacks or strokes, although the exact level of risk may vary between medicines. The MHRA has widely communicated the latest information and advice for healthcare professionals in letters and bulletins, and other publications through liaison with the British National Formulary and National Prescribing Centre. In addition, product information (including patient information leaflets) has been updated in order to support informed decision-making in relation to the choice of anti-inflammatory medicine.