Drugs in lactation Source: LactMed

Withania and Breastfeeding

Summary of use during lactation

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.

Drug levels in milk and infant serum

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

Effects in breastfed infants

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

Effects on lactation and breastmilk

Forty women who complained of an insufficient milk supply at 5 days postpartum were given a combination herbal supplement as 2 capsules of Lactare (Pharma Private Ltd., Madras, India) 3 times daily. Each capsule contained wild asparagus 200 mg, ashwagandha (Withania somnifera) 100 mg, fenugreek 50 mg, licorice 50 mg, and garlic 20 mg. By day 4 of therapy, no infants required supplementary feeding. Infants were weighed before and after each feeding on day 5 of maternal therapy to determine the amount of milk ingested. On the day of the test weighing, infants' milk intake averaged 388 mL, and the fluid and caloric intake was considered adequate.[1] This study cannot be considered as valid evidence of a galactogogue effect of these herbs because it lacks randomization, blinding, a placebo control, and maternal instruction in breastfeeding technique. Additionally, infants were breastfed only 6 to 8 times daily, which is insufficient to maximize milk supply.

References

  1. Sholapurkar M. 'Lactare' for improving lactation. Indian Pract 1986;39:1023-6.
  2. Rasiya Beegam A, Nayar T. Plants used for natal healthcare in folk medicine of Kerala, India. Indian J Tradit Knowl 2011;10:523-7.
  3. Brodribb W. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting maternal milk production, second revision 2018. Breastfeed Med 2018;13:307-14.29902083 PubMed
  4. Breastfeeding challenges: ACOG Committee Opinion, Number 820. Obstet Gynecol 2021;137:e42-e53.33481531 PubMed

Source: Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, NCBI Bookshelf. Check LactMed for the most recent revision.

Medical disclaimer: This page is for qualified healthcare professionals and is a decision-support aid only. It does not replace clinical judgement, local protocols or product information. Verify every dose and threshold before use. See the full Medical Disclaimer.