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The Safety and Efficacy of Clopidogrel in Children with Heart Disease: A Systematic Review

1 December 2010


Background: Clopidogrel, an oral antiplatelet, has been used off-label in pediatric patients at risk for thrombosis, including those with heart disease, for more than a decade. While numerous clinical trials in adults have resulted in the formation of comprehensive management guidelines, considerably less is known about the safety and efficacy of clopidogrel use in children.

Method: An exhaustive literature search was performed using PubMed, Web of Science, Cochrane, Medline, CINAHL and International Pharmaceutical Abstracts. The keywords searched included “clopidogrel”, “child”, “teen”, “young”, “pediatric”, “boy”, “girl”, “adolescent” and “heart diseases” individually and in combination. The search was limited to the English language and articles older than ten years were excluded. After eliminating duplicate articles and those irrelevant to the topic of interest, seven studies were identified for review and three were selected.

Results: Three studies were reviewed, two of which were retrospective chart reviews and one randomized control trial. These studies included children with congenital or acquired heart disease, ages 8 days to 18 years old. Doses varied by study from 0.01 mg/kg/day to 6 mg/kg/day. Very few thrombotic events occurred and these events were rarely attributed to clopidogrel. The most frequent complication was skin bruising and minor bleeding.

Conclusion: Clopidogrel appears to be relatively well tolerated in infants and children at low doses, but should be used cautiously, particularly when administered in combination with other antiplatelet or anticoagulants, as it may increase bleeding risks.

Keywords: Clopidogrel, Heart Diseases, Child and Pediatric


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