Can I take rosuvastatin while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Rosuvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. Rosuvastatin should be discontinued as soon as pregnancy is recognized [see Contraindications (4) ] . Limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (MRHD) of 40 mg/day in rats or rabbits (based on AUC and body surface area, respectively). In rats and rabbits, decreased pup/fetal survival occurred at 12 times and equivalent, respectively, to the MRHD of 40 mg/day [see Data ] .

Prescribing label, section “8.1 Pregnancy” (opening excerpt): ROSUVASTATIN CALCIUM (oral), Bryant Ranch Prepack. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Levels of rosuvastatin in milk are low, and one case of an older infant breastfed during maternal rosuvastatin therapy found no adverse effects. 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] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

“Summary of Use during Lactation”, LactMed record “Rosuvastatin” (LM486), quoted verbatim. Everything LactMed reports about Rosuvastatin while breastfeeding.

8.2 Lactation Risk Summary Rosuvastatin use is contraindicated during breastfeeding [see Contraindications (4) ] . Limited data indicate that rosuvastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with rosuvastatin.

Prescribing label, section “8.2 Lactation”: ROSUVASTATIN CALCIUM (oral), Bryant Ranch Prepack. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.