REUTERS
Mon Feb 21, 2005 7:45 AM ET
FRANKFURT (Reuters) - Germany will issue guidelines in the next few days to significantly restrict the use of so-called COX-2 inhibitors to ease pain, the country's drug regulator said on Monday.
Patients who either have had a heart attack or stroke, suffer from circulatory disorders of the heart or are at a high risk of developing such conditions should no longer use the medications, the regulator said in a statement.
The regulator's remarks come close on the heels of comments by a U.S. advisory panel on Friday that Merck & Co Inc.'s withdrawn COX-2 inhibitor arthritis drug, Vioxx, was safe enough to rejoin Pfizer's rival pain relievers, Celebrex and Bextra, on the U.S. market.
The German regulator said patients with high blood pressure that can not be stabilized also should not use etoricoxib, another name for Merck & Co's Arcoxia.
The German regulator said that COX-2 inhibitors-- the general category to which Arcoxia, Vioxx, Celebrex and Bextra belong -- should be taken only in the smallest possible effective dose and only as long as absolutely needed.
It said that a risk evaluation process in the European Union for the class of COX-2 inhibitors was continuing and that a report was expected in April.
