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Title: Alert Issued on Clopidogrel

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N Engl J Med April 20, 2000
04/24/2000
By Anne MacLennan

Physicians are being warned that thrombotic thrombocytopenic purpura can occur after initiation of the anti-platelet drug, clopidogrel, often within the first two weeks of treatment. [The New England Journal of Medicine has taken the unusual step of alerting readers via the Internet, and in advance of its formal publication, to a report on 11 patients in whom thrombotic thrombocytopenic purpura developed during or soon after treatment with clopidogrel. The United States Food and Drug Administration (FDA) approved the new antiplatelet drug in early 1998. Two earlier cases of thrombotic thrombocytopenic purpura that occurred after clopidogrel use have been reported at medical conferences. More than three million patients have received clopidogrel, believed to have a superior safety profile to ticlopidine, which it has largely replaced and which was itself associated with thrombotic thrombocytopenic purpura. Ten of the 11 patients in this report received clopidogrel for two weeks or less before onset of the condition. Although 10 responded to plasma exchange, two required 20 or more exchanges before any improvement was evident and two had relapses while not receiving clopidogrel. One patient died despite undergoing plasma exchange soon after diagnosis. Clinical trials and studies involving 20,000 patients on clopidogrel have reported none of the effects associated with ticlopidine. Ticlopidine-associated thrombotic thrombocytopenic purpura was not widely recognized until seven years after the drug was approved by the FDA, despite its use by several million patients.

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