Arcoxia to get CV European label warnings

Finalizing a review of the benefits and risks of US drug major Merck & Co's Arcoxia (etoricoxib), the European Medicines Agency (EMEA) has concluded that it can be used to treat rheumatoid arthritis and ankylosing spondylitis, but recommended that the product information should be updated on the risk of cardiovascular side effects.

The COX-2 selective non-steroidal anti-inflammatory drug is currently indicated to relieve the symptoms of osteoarthritis, RA and pain and signs of inflammation associated with acute gouty arthritis. In addition, an application is currently under evaluation to extend the indication of Arcoxia to AS. The EMEA's Committee for Medicinal Products for Human Use (CHMP) was asked by France to look at the benefits and risks of Arcoxia for the long-term treatment of RA and AS to determine whether the marketing authorization should be changed or even possibly withdrawn across the European Union.

Following review of all available data, the CHMP concluded that the benefits of etoricoxib-containing medicines outweigh their risks for the treatment of RA and AS when used at a daily dose of 90mg. It therefore recommended that the extension of the indication for Arcoxia to include AS be granted and that the indication in RA could be maintained. However, the Committee recommended updating the existing contraindication in patients with hypertension that is not adequately controlled to state that those whose blood pressure is persistently above 140mmHg/90mmHg and has not been adequately controlled should not take the medicine. In addition, the CHMP concluded that warnings should be added stating that high blood pressure should be controlled before treatment is begun.