In: Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006.


Withania (Withania somnifera) roots and berries contain alkaloids, steroidal lactones, and saponins. It is called ashwagandha in ayurvedic medicine where it is sometimes used as a galactogogue.[1,2] However, no scientifically valid clinical trials support this use. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[3,4] No data exist on the excretion of any components of Withania into breastmilk or on the safety and efficacy of Withania in nursing mothers or infants. In general, Withania is generally well tolerated in adults with occasional severe diarrhea, skin burning, sedation and discoloration and allergic skin reactions. It should be used cautiously by patients with diabetes, hypertension or men with hormone-sensitive prostate cancer. Because there is no published experience with Withania during breastfeeding, it should be avoided, especially while nursing a newborn or preterm infant.

Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.

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