New advice on anti-inflammatory drugs called Cox-2 Inhibitors, including Celebrex

Dec 21 2004

The Medicines and Healthcare products Regulatory Agency (MHRA) today issued new advice on anti-inflammatory drugs called Cox-2 Inhibitors, including Celebrex.

Patients who are taking Celebrex, Bextra and Arcoxia should make a non-urgent appointment with their GP to review their treatment. Patients who have established heart disease or who are at high risk of stroke will have their treatment changed. For all other patients, alternative treatments will be considered on the basis of their medical history.

Celebrex and other drugs of the same type are used in the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis, and in the management of acute pain. The drugs are widely used, Celebrex is used by an estimated 600,000 patients in the U.K.

The new advice follows new clinical trial data. The study, conducted by the US Cancer Institute, is reported to show that patients were at an increased risk of heart attack and stroke after taking Celebrex.

Chairman of the Committee on the Safety of Medicines, Professor Gordon Duff said:

"Patients taking any of these drugs should contact their doctor at the next convenient appointment to discuss their treatment. The Committee on the Safety of Medicines is waiting for the study data. Once this is available the Committee will carefully consider this and issue further advice".

Notes
Another Cox-2 Inhibitor Rofecoxib (Vioxx) was withdrawn by the manufacturer in September 2004 following the results of a long term study that showed an increased risk of heart attack and stroke after 18 months or more.

The study was conducted by the US National Cancer Institute and involved 2400 patients with an average duration of 33 months treatment taking 400mg or 800mg of celecoxib per day. The risk of heart attack or stroke was 2.5 times higher than placebo at 400mg and 3.4 times higher than with the 800mg dose.