Lepirudin administration during prospective studies in patients with HIT was associated with a low incidence of allergic events, as well as during the much larger clinical trials in patients with ACS. Among the adverse events reported were eczema, rash, pruritus, hot flushes, fever, chills, urticaria, bronchospasm, cough, stridor, dyspnea, angioedema (face, tongue, larynx), and injection-site reactions. Any causal relationship of lepirudin to these adverse events is unclear.
Of 35,000-60,000 patients treated with lepirudin, nine patients were judged to have had severe anaphylaxis in close temporal association with lepirudin use (Greinacher et al., 2003b). All reactions occurred within minutes of iv bolus lepirudin administration, with four fatal outcomes (3 acute cardiorespiratory arrests, one hypotension-induced MI). In these four cases, a previous uneventful treatment course with lepirudin was identified (1-12 wk earlier). In an additional patient with nonfatal anaphylaxis (who did not receive a bolus), we found high-titer IgG antilepirudin antibodies. Since lepirudin had been used in approximately
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