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Bextra suspension confirmed in EU

Published on 09/11/05 at 09:52am

The European Commission has confirmed that Pfizer's Cox-II product Bextra will remain suspended from the market because of safety concerns.

The European Medicines Agency recommended the suspension in June because of cardiovascular safety concerns and serious skin reactions, two months on from Pfizer's own voluntary suspension of the product.

The regulator's medicines committee the CHMP ruled that Bextra could no longer be safely used after 'severe and unpredictable' cutaneous adverse reactions were reported in a number of patients.

The agency said this affected the product's overall benefit/risk profile and added that it was not possible to restrict the indications or add adequate contraindications to permit its safe use.

The suspension of Bextra will be reviewed after one year, with Pfizer given the opportunity to provide new safety data and other relevant data to the committee.

The Cox-IIs remaining on the market, which include Pfizer's Celebrex and Merck Sharp & Dohme' s Arcoxia, have been given a number of new label warnings and contraindications.

Related articles:

US rejects Pfizer's injectable Cox-II

Thursday , September 22, 2005

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