PEDIATRICS Vol. 80 No. 1 July 1987, pp. 120
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Fetal Minoxidil Exposure

FRANZ W. ROSA 1, JUHANA IDANPAAN-HEIKKILA 2, and RITA ASANTI 3

1 Food and Drug Administration HFN 733, Rockville, MD 20851
2 National Board of Health, Helsinki, Finland
3 State Maternity Hospital, Helsinki, Finland

To the Editor.—

Kaler et al (Pediatrics 1987;79:434-436) provided a case report of hypertrichosis and multiple congenital anomalies with maternal minoxidil use. Reports such as this contribute to alerting national drug safety offices of possible teratologic questions. Maternal drug exposure data, since 1979 when minoxidil was marketed, is available to the Food and Drug Administration (FDA) from 73,000 pregnancies (15,600 birth defects, 4,400 spontaneous abortions, and 53,000 normal outcomes). This yields, in addition to the report by Kaler et al, only two other births with maternal minoxidil exposures: