Gestational Exposure to Lovastatin Followed by Cardiac Malformation Misclassified as Holoprosencephaly

To the Editor: In 2004, we reported central nervous system and limb anomalies that followed exposure to statin drugs in the first trimester of pregnancy (April 8, 2004, issue).1 One case, in which there had been exposure to lovastatin, was described as involving holoprosencephaly on the basis of three separate reports of a “cerebral/brain ventricular septal defect,” with accompanying cardiac malformations that had been submitted to the Food and Drug Administration adverse-event database. We recently learned that the manufacturer considered the structural anomalies to be solely cardiac, and therefore we requested source documentation to clarify the conflicting reports. A detailed . . .