title: Teratogenic risk of statins in pregnancy.
abstract: OBJECTIVE
  To evaluate the teratogenic potential of statins in women of child-bearing age.
  
  
  METHODS
  A PubMed search (1980-September 2012) was performed using the search terms statin and pregnancy, then repeated using statin and teratogenicity. Results were limited to articles published in English reporting on use of statins in humans.
  
  
  METHODS
  All articles presenting data on pregnancy outcomes after statin use during any trimester of pregnancy were included. Three case reports, 2 case series, 2 systematic reviews, 2 registry-based studies, and 1 prospective observational cohort study were reviewed.
  
  
  RESULTS
  Since initial premarketing studies of lovastatin in animals, teratogenesis has been assumed to be a classwide function of statins' mechanism of action. Data from human exposure during pregnancy have been gathered and analyzed in a variety of study formats to formulate useable conclusions on statins' actual teratogenic risk and pattern of associated birth defects. Although the current trend is that actual risk is lower than once thought, the available literature is limited by potential reporting bias, contains overlap in the data, and frequently lacks numbers of total exposures to statins during pregnancy with reported malformations. Additionally, no human studies included data on the 2 newest statins (rosuvastatin, pitavastatin); the more lipophilic statins (lovastatin, simvastatin) have the most experience and thus have more evidence related to teratogenic potential.
  
  
  CONCLUSIONS
  Human teratogenic risk has not been proven nor has it been ruled out by the available data on statin use in pregnancy. Possible differences in risk between individual statins require further evaluation. Additional data, including prospective observational cohorts with inadvertent maternal exposure to statins during early weeks of gestation, should further help to clarify appropriate recommendations for statin use in this population.
authors.affiliation: Portneuf Medical Center, Pocatello, ID, USA.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Godfrey
authors.forename: John
authors.initials: J
authors.lastname: Erramouspe
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Cleveland
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D012306:Risk
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors