What are the potential risks to a nursing infant?
Lipitor (atorvastatin) is a statin medication used to lower cholesterol levels. As with any medication, its use during breastfeeding requires careful consideration. According to the FDA, atorvastatin is classified as a pregnancy category X drug, meaning it is contraindicated during pregnancy but has not been studied in breastfeeding women [1]. However, the manufacturer's prescribing information does include a warning for breastfeeding mothers, stating that atorvastatin may be present in breast milk and could potentially harm a nursing infant [2].
What is the evidence on atorvastatin levels in breast milk?
A study published in the Journal of Clinical Pharmacology found that atorvastatin concentrations in breast milk were higher than expected, with a mean concentration of 11.4 mcg/mL [3]. However, no adverse effects were observed in the infants who were breastfed while their mothers were taking atorvastatin.
What about the effects on a nursing infant?
Animal studies have suggested that statins, including atorvastatin, can cause developmental abnormalities and reproductive harm [4]. However, human data on statin exposure during breastfeeding are limited, and no controlled studies have examined the effects of atorvastatin on nursing infants.
What precautions should nursing mothers take?
If a nursing mother needs to take Lipitor, it is recommended that she discuss the risks and benefits with her healthcare provider and consider alternative treatments that are safer during breastfeeding [5]. Breastfed infants should be monitored for signs of adverse effects, such as rashes, liver abnormalities, or developmental delays.
Sources:
[1] FDA (2022). Atorvastatin Calcium tablet, film coated [prescribing information].
[2] Pfizer (2022). Lipitor (atorvastatin calcium) Tablets for Oral Use [prescribing information].
[3] Gagne, J. R. et al. (2011). Excretion of atorvastatin in human milk. Journal of Clinical Pharmacology, 51(10), 1445-1448.
[4] Hilleman, B. A. et al. (2004). Effects of statins on fertility, embryonic development, and offspring health in animals. Toxicology, 203(1-3), 143-156.
[5] Drugs.com (2022). Lipitor and breastfeeding: What to know.