Interventions should include aggres- sive lifestyle counseling to reduce ASCVD risk and when appropriate, statin therapy, if ASCVD risk estimation indicates that the potential for benefit from statin therapy outweighs the potential for adverse effects. Decisions should be made in the context of a risk discussion and should take into consideration an informed patient preference. 2. All statins are currently contraindicated in pregnant women, primarily as a result of a 2004 series of cases of first-trimester statin exposure reported to the FDA, which showed 20 cases of malformation, including 5 severe defects of the central nervous system and 5 unilateral limb deficiencies.S4.5.3-7 In all cases of adverse birth outcomes, the statin used was lipophilic. No malformation was identified in the 14 infants exposed to pravastatin (hydrophilic). Since this case series, cohort studies of statin expo- sure in pregnancy did not show an increase in and in fact, the safety of pravastatin is under study for the prevention of preeclampsia in high-risk pregnant women.S4.5.3-15 In a meta-analysis of 6 studies of pregnant women exposed to statins, no increased risk of birth defects was observed compared with control subjects. However, there was an increased risk of CLINICAL STATEMENTS AND GUIDELINES miscarriage in the statin-exposed women versus Furthermore, in a recent retrospec- tive cohort study that used time-to-event analysis as a covariate, the adjusted hazard ratio of sponta- neous pregnancy loss in the statin-exposed group The increase in miscarriages may be related to confounders, such as older age, CVD risk factors, and other medications. 3. A reasonable approach is to stop statins 1 to 2 months before pregnancy is attempted. When pregnancy is unplanned, statin therapy should be stopped promptly and not restarted until after pregnancy and breastfeeding are completed. 