Atorvastatin

The Basics

What is Atorvastatin?

Used to lower cholesterol and triglyceride levels in the blood.

Brand names for Atorvastatin

Lipitor

How Atorvastatin is classified

Anticholesteremic Agents, Antilipemic Agents, Hydroxymethylglutaryl-CoA Reductase Inhibitors

Atorvastatin During Pregnancy

Atorvastatin pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Atorvastatin while pregnant

LIPITOR is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, LIPITOR may cause fetal harm when administered to a pregnant woman. LIPITOR should be discontinued as soon as pregnancy is recognized . Limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformation sat doses up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD)of 80 mg, based on body surface area (mg/m²). In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥ 6 times the MRHD (see Data). The estimated back ground risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 1520%, respectively. Data Human Data Limited published data on atorvastatin calcium from observational studies, meta-analyses and case report shave not shown an increased risk of major congenital malformations or miscarriage. Rare reports of congenital anomalies have been received following intrauterine exposure to other HMG-CoA reductase inhibitors. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥ 3to 4-fold increase in congenital anomalies over the background incidence. In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300mg/kg/day and 100mg/kg/day, respectively. Atorvastatin was notteratogenic in rats at doses up to 300mg/kg/day or in rabbits at doses up to 100mg/kg/day. These doses resulted in multiples of about 30 times (rat) or20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m²).In rats, the maternally toxic dose of 300mg/kg resulted in increased post-implantation loss and decreased fetal body weight. At the maternally toxic doses of 50 and 100mg/kg/day in rabbits, there was increased post-implantation loss, and at 100mg/kg/day fetal body weights were decreased. In a study inpregnantratsadministered20, 100, or 225 mg/kg/day from gestation day7 through to lactation day20(weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225mg/kg/day, a dose at which maternal toxicity was observed. Pup body weight was decreased through postnatal day 21at 100 mg/kg/day, and through postnatal day91 at 225 mg/kg/day. Pup development was delayed (rotorod performance at 100mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225mg/kg/day). These doses correspond to 6 times (100 mg/kg) and 22times (225 mg/kg) the human exposure at the MRHD, based on AUC.

Taking Atorvastatin While Breastfeeding

What are recommendations for lactation if you're taking Atorvastatin?

The consensus opinion is that women taking a statin should not breastfeed because of a concern with disruption of infant lipid metabolism. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Some evidence indicates that atorvastatin can be taken by nursing mothers with no obvious developmental problems in their infants. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

The consensus opinion is that women taking a statin should not breastfeed because of a concern with disruption of infant lipid metabolism. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Some evidence indicates that atorvastatin can be taken by nursing mothers with no obvious developmental problems in their infants. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Atorvastatin on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Atorvastatin

Cholestyramine, Colesevelam, Colestipol.