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30 September 2004
The Committee on Safety of Medicines has today been informed of the immediate voluntary worldwide withdrawal of the 'COX-2 selective NSAID 'rofecoxib (Vioxx/VioxxAcute) by the manufacturer. This follows new clinical trial results showing an increased risk of confirmed serious thrombotic events (including myocardial infarction and stroke) compared to placebo, following long-term use.
Patients taking Vioxx/VioxxAcute should contact their doctor by telephone or at the next convenient appointment to arrange an alternative prescription.
The new data and advice is specific to rofecoxib.
Background
Rofecoxib is a cyclo-oxygenase-2 (COX-2 selective) non-steroidal anti-inflammatory medicine (NSAID) first used in the UK in 1999. It is indicated for osteoathritis, rheumatoid arthritis (Vioxx) and higher
dose-strengths are indicated for short-term relief of acute pain (VioxxAcute).
The cardiovascular safety of rofecoxib and other COX-2 inhibitors has been reviewed by the Committee on Safety of Medicines on a number of occasions since 2000, as evidence of a possible increase in risk of cardiovascular events has emerged.
COX-2 inhibitors do not affect platelet function and are therefore not thought to offer anti-thrombotic cardiovascular protection afforded by some non-selective NSAIDs (e.g. naproxen). The possibility of an additional thrombotic risk has, up until now, not been established although this possibility has resulted in changes to the Summary of Product Characteristics and Patient Information Leaflets highlighting the need for caution in high risk patients.
New data
The APPROVE study was a multi-centre, randomised, placebo-controlled, double-blind study to determine the effect of 3 years treatment with Vioxx on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial, which started in 2000, enrolled
2,600 patients and compared Vioxx 25mg to placebo. In this study 25 patients taking placebo versus 45 patients taking Vioxx experienced a confirmed serious thrombotic event. The absolute event rates were approximately 3 per 400 patient years for placebo and 6 per 400 patient years for Vioxx, i.e. an absolute increase in risk of approximately 3 thrombotic events per 400 patient years of treatment. The difference in
event rates was only apparent after 18 months of treatment.
On the basis of these data the Marketing Authorisation holder for rofecoxib (Merck Sharp and Dohme) has today announced that it is withdrawing the product world-wide, with immediate effect, and is stopping all clinical trials. The new data relate specifically to rofecoxib and is not generalised to
other selective COX-2 inhibitors.
What action should patients take?
Patients taking Vioxx/VioxxAcute should contact their doctor by telephone or at the next convenient appointment to arrange an alternative prescription.
It is important that serious suspected adverse drug reactions (ADRs) are reported to the Committee on Safety of Medicines using the Yellow Card Scheme. Please report all suspected ADRs for black triangle medicines.
