Editor's Note: This study was supported by a Agency for Healthcare Research and Quality grant and by the Aetna Quality Care Research Fund.
Editorial: Ximelagatran - Promises and Concerns
In an accompanying editorial, Victor Gurewich, M.D., of Beth Israel Deaconess Hospital Medical Center, Boston, comments on the studies on ximelagatran in this week's JAMA.
"With respect to the more troublesome possibility of long-term adverse effects from [ximelagatran], it seems unlikely that yet another clinical trial will resolve this question. Diligent postmarketing surveillance is essential to monitor use and to determine the risks associated with this agent, and this may be the best, if not the only, way to deal with this question. It is possible that such data will become available from Europe, but this is unlikely at present since for now only short-term use has been approved. In the United States, the Food and Drug Administration, perhaps feeling the effects of recently having to withdraw drugs from the market, has denied approval of ximelagatran because of concerns about hepatotoxicity. However, this precaution concerning the risk of hepatotoxicity from ximelagatran must be balanced against the serious risk of discouraging, if not foreclosing indefinitely, any improvement in oral anticoagulant therapy, which remains an important and growing therapeutic need."
(JAMA. 2005;293:736-739. Available post-embargo at JAMA.com)
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Contact: Bruce L. Davidson, M.D.
206-215-2500
JAMA and Archives Journals
8-Feb-2005