BACKGROUND: Our objective was to determine the frequency of adverse outcomes after maternal exposure to @entity3413 and/or @entity5753 during pregnancy in postmarketing experience. METHODS: We reviewed the Merck _ Co., Inc. (West Point, PA) pharmacovigilance database for reports of exposure to @entity3413 or @entity5753 during pregnancy. The reports were classified as prospective (reported prior to pregnancy outcome) or retrospective (reported after pregnancy outcome) and were evaluated for timing of exposure, outcome, @entity154 , and other events. Outcome rates were calculated for prospective pregnancies. RESULTS: We identified 477 reports (386 prospective and 91 retrospective) with 225 prospective outcomes reported: 154 live born @entity1 , 49 elective abortions, 18 @entity5617 . Six @entity154 were reported: chromosomal translocation, @entity7440 , @entity2650 , @entity15960 , @entity3384 , and @entity272 . The rate of @entity154 ( @entity154 /live births plus @entity5617 ) was 3.8%, which is similar to the background population rate (3.2%; relative ratio, 1.21; 95% 1-sided upper confidence interval [CI], 2.02). There were 13 retrospective reports describing a range of @entity154 . No specific @entity7944 was identified in either the prospective or retrospective reports. Rates for other outcomes were similar to background rates. CONCLUSIONS: Although the number of reports was relatively small, there was no evidence of a notable increase in @entity154 in @entity1 exposed to @entity3413 or @entity5753 versus the general population. Greater reporting of @entity154 in the retrospective cohort is not unexpected and may reflect a reporting bias. Drugs should be used during pregnancy only if the benefits outweigh the risks. @entity3413 and @entity5753 remain contraindicated during pregnancy.

Pregnancy outcomes after maternal exposure to @entity3413 and XXXX .

@entity1 :: ('9606', 'Species') :: ['women', 'infants'] @entity154 :: ('MESH:D000013', 'Disease') :: ['congenital abnormalities', 'congenital anomalies'] @entity3413 :: ('MESH:D019821', 'Chemical') :: ['Simvastatin', 'simvastatin'] @entity2650 :: ('MESH:D007021', 'Disease') :: ['hypospadias'] @entity7944 :: ('MESH:C536309', 'Disease') :: ['pattern of anomalies'] @entity5753 :: ('MESH:D008148', 'Chemical') :: ['lovastatin'] @entity272 :: ('MESH:D012871', 'Disease') :: ['skin tag'] @entity3384 :: ('MESH:D002971', 'Disease') :: ['cleft lip'] @entity5617 :: ('MESH:D005313', 'Disease') :: ['fetal deaths', 'spontaneous abortions, and 4 fetal deaths'] @entity7440 :: ('MESH:C580500', 'Disease') :: ['trisomy 18'] @entity15960 :: ('MESH:C535720', 'Disease') :: ['duodenal atresia']
@entity5753 :: (MESH:D008148,Chemical) :: ['lovastatin']
