Background: This study aimed to provide descriptive information about off-label treatment practice with clopidogrel in a pediatric population.
Methods: Patients less than 18 years of age prescribed clopidogrel between March 2002 and August 2005 were retrospectively identified at Children's Hospital, Boston. Data from the time of first documented clopidogrel use to the most recent follow-up assessment were collected. Adverse events were classified according to seriousness and relationship to clopidogrel.
Results: Of the 90 patients in the study, 53% were boys. The median age of the patients was 6.7 years, and their median weight was 23.6 kg at first clopidogrel use. Prescriptions were predominantly for cardiac indications (96%), with a few for neurologic indications (4%). Common cardiac indications were history of thrombosis involving a conduit or shunt, abnormal vasculature with potential for low flow, and device placement. The median total dose was 1.3 mg/kg/day, and the duration of therapy varied from less than 1 day to 4 years (median, 45 days). Three patients experienced minor bleeding, all of whom were receiving concomitant acetylsalicylic acid. Another patient experienced catastrophic bleeding after vessel tear during catheterization. One patient with a fenestrated Fontan and poor ventricular function had baffle thrombosis and subsequent stroke while receiving clopidogrel and acetylsalicylic acid.
Conclusions: Clopidogrel was prescribed most often to prevent thrombosis in patients with cardiac disease. Patients with neurologic conditions also were treated. Bruising and bleeding events occurred rarely.