POSTMARKETING SURVEILLANCE OF LOVASTATIN AND SIMVASTATIN EXPOSURE DURING PREGNANCY

Pregnancy outcomes in women with inadvertent exposure to lovastatin an d simvastatin during pregnancy have been examined based on reports sub mitted to the manufacturer as part of worldwide postmarketing surveill ance, There were 134 reports of exposure during pregnancy in which pre gnancy outcome was known, Among prospectively followed pregnancies wit h known outcome, the proportion of normal outcomes was 85%, congenital anomalies 4.0%, spontaneous abortions 8.0%, fetal deaths/stillbirths 1.0%, and miscellaneous adverse outcomes 2.0%, While the number of pro spective reports available for evaluation were only sufficient to rule out a three- to fourfold increase in the overall frequency of congeni tal anomalies, these proportions do not exceed what would be expected in the general population, Based on findings from this interim evaluat ion, there is no relationship between exposure to therapeutic doses of these agents during pregnancy and the occurrence of adverse pregnancy outcomes. (C) 1996 Elsevier Science Inc.