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Irish regulators make statement regarding Bextra safety

-April 11, 2005

The Irish Medicines Board (IMB) has said it is advising doctors not to prescribe any new patients the painkiller Bextra, as well as asking doctors to review treatment plans for patients already taking Bextra.

The IMB says its advice to doctors is being taken as a precautionary measure while the final assessment of the risks vs. benefits of Bextra is completed. The agency said it expects this to be completed within or around 10 days. Bextra sales have been suspended in the United States and Europe in response to requests by regulators.

According to the IMB, the use of Bextra in Ireland is considered low - about 3,000 patients are currently being treated with the drug. Bextra is part of a controversial group of drugs, called COX-2 inhibitors, which include another withdrawn drug Vioxx, as well as Pfizer Inc.'s other painkiller Celebrex.

After Vioxx was recalled last September because of a study showing it was linked to increased risks of heart attacks and strokes, the safety of the entire class of drugs was questioned. Bextra, in addition to being linked to cardiovascular risks, is also linked to a potentially deadly skin disease.

The IMB said it is taking part in a European Union wide review of Bextra through its membership of the European Agency for the Evaluation of Medicinal Products.

For more information on Bextra recall, please contact us.

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