Key result
Maternal clopidogrel shows <1% relative infant dose via human milk with no short-term adverse events.
Why the study?
Implementation of breastfeeding recommendations is hampered by lacking information regarding medicine safety during breastfeeding.
Does clopidogrel transfer into human milk and expose infants to significant levels?
Case Report (n=2)
Does clopidogrel transfer into human milk and expose infants to significant levels?
Clopidogrel transfer into human milk appears low, resulting in minimal infant exposure, though further safety studies are needed.
Introduction: Implementation of breastfeeding recommendations is hampered by-among others-lacking information regarding medicine safety during breastfeeding. This article describes the clinical and pharmacokinetic data of breastfeeding mothers using clopidogrel (CLP) as secondary prevention following (suspicion of) a cerebrovascular accident. Methods: (patient 2). Each sampling period, two maternal blood samples as well as one infant blood sample were collected. Concentrations of CLP, clopidogrel carboxylic acid (CCA) and clopidogrel active metabolite (CAM) derivatized were analyzed using liquid chromatography with tandem mass spectrometry. Results: The average steady-state concentration in human milk was 0.96 and 7.40 ng/mL for CLP and CCA, respectively. CAM concentrations in all but two milk samples were below the limit of detection (LOD; 0.004 ng/mL). In the infant plasma sample, CCA level was 0.05 ng/mL but CLP and CAM were undetectable (CLP LOD: 0.003 ng/mL). The mean daily infant dosage (DID) was 82.3, 585.6 and 1.5 ng/kg/day for CLP, CCA and CAM, respectively, and the relative infant dose (RID) for CLP-related exposure remained well below 1%. Discussion: The estimated infant exposure to CLP and its metabolites via human milk was low in both cases. Although this low exposure was supported by the observed infant plasma concentration, additional studies should confirm CLP safety via human milk, especially considering known variable pharmacokinetics and ontogeny of metabolizing enzymes in infants.
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Neste et al. (2025) conducted a case report in Cerebrovascular accident (secondary prevention during breastfeeding) (n=2). Clopidogrel was evaluated on Average steady-state concentration of clopidogrel and its metabolites in human milk and relative infant dose (RID). Maternal use of 75 mg daily clopidogrel resulted in low estimated infant exposure via human milk, with a relative infant dose well below 1% and no reported short-term adverse events.
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