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news.German regulatory body BfArM has revealed that it will introduce new restrictions guidelines covering the use of COX-2 inhibitors, such as Pfizer's Bextra and Celebrex and Merck & Co's Arcoxia.
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The regulator has stated that the medications should no longer be used by patients who have suffered or are at high risk of having a heart attack, stroke or circulatory heart disorders. Furthermore, etoricoxib (Merck & Co’s Arcoxia) should not be used for patients with high blood pressure that cannot sufficiently be controlled, BfArM (Bundesinstitut fur Arzneimittel und Medizinprodukte) said.
In the new product guidelines, it will be pointed out that the use of COX-2 medications should be limited to the lowest effective dosage and for only so long as is absolutely necessary.
This move follows recent reviews of the COX-2 class, for which a comprehensive risk appraisal is continuing in the European Union, with a report expected in April 2005.