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Title: EMEA Recommends Updated Label Warnings for Etoricoxib-Containing Drugs
URL: http://www.pslgroup.com/dg/22471E.htm
Doctor's Guide
June 27, 2008

LONDON -- June 27, 2008 -- Finalising a review of the benefits and risks of etoricoxib-containing medicines, the European Medicines Agency (EMEA) has concluded that these medicines can be used to treat rheumatoid arthritis and ankylosing spondylitis, but recommended that their product information should be updated concerning the risk of cardiovascular side effects.

In the context of the evaluation of the application for extension of indication, concerns were raised over the cardiovascular safety of etoricoxib-containing medicines when used to treat ankylosing spondylitis at a dose of 90 mg QD. These concerns also extended to the treatment of rheumatoid arthritis, which is used at the same dose.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) was asked to look at the benefits and risks of etoricoxib for the long-term treatment of rheumatoid arthritis and ankylosing spondylitis to determine whether the marketing authorisations for these medicines should be maintained, varied, suspended, or withdrawn across the European Union. The review did not concern osteoarthritis and acute gouty arthritis.

Following review of all available data, the CHMP concluded that the benefits of etoricoxib-containing medicines outweigh their risks for the treatment of rheumatoid arthritis and ankylosing spondylitis when used at a dose of 90 mg QD, and therefore recommended that the extension of indication to include ankylosing spondylitis be granted, and that the indication in rheumatoid arthritis could be maintained.

However, the CHMP recommended updating the existing contraindication in patients with hypertension that is not adequately controlled to state that patients whose blood pressure is persistently above 140/90 mm Hg and has not been adequately controlled should not take the medicine. In addition, the CHMP concluded that warnings should be added to the product information for etoricoxib-containing medicines, stating that high blood pressure should be controlled before treatment is begun and should be monitored for 2 weeks after the start of treatment and regularly thereafter.

Physicians should prescribe etoricoxib-containing medicines according to the updated product information. Physicians are advised to monitor closely any signs or symptoms of cardiovascular side effects.

SOURCE: European Medicines Agency

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