Remember ME - You Me and Dementia
June 26, 2008
EUROPE: EU strengthens heart warnings on Merck's Arcoxia
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LONDON, England / Reuters / June 26, 2008:
The European Medicines Agency said on Thursday it had concluded that Merck & Co's Arcoxia can be used to treat rheumatoid arthritis and ankylosing spondylitis but with heightened warnings on cardiovascular risks.
Arcoxia is approved in Europe but was rejected by the U.S. Food Drug and Administration. The medicine is a follow-up to Merck's withdrawn painkiller Vioxx.
The European watchdog said the benefits of Arcoxia, also known as etoricoxib, outweighed the risks for the treatment of rheumatoid arthritis and ankylosing spondylitis when used at a dose of 90 mg once a day.
It therefore recommended that an extension of indication for Arcoxia to include ankylosing spondylitis be granted and that the indication in rheumatoid arthritis could be maintained.
But agency experts recommended updating the existing contraindication in patients with inadequately controlled hypertension to state that those with blood pressure above 140/90 mmHg should not take the medicine.
They also want new warnings stating that high blood pressure should be controlled before treatment is begun.
By Ben Hirschler
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