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

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Drugs and Lactation Database (LactMed®) [Internet].

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Withania

Last Revision: March 17, 2021.

Estimated reading time: 2 minutes

CASRN: 90147-43-6

Drug Levels and Effects

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

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 ML. 'Lactare' for improving lactation. Indian Pract. 1986;39:1023–6.
2.
Rasiya Beegam A, Nayar TS. 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. [PubMed: 29902083]
4.
Breastfeeding challenges: ACOG Committee Opinion, Number 820. Obstet Gynecol. 2021;137:e42–e53. [PubMed: 33481531]

Substance Identification

Substance Name

Withania

Scientific Name

Withania somnifera

CAS Registry Number

90147-43-6

Drug Class

Breast Feeding

Lactation

Complementary Therapies

Phytotherapy

Plants, Medicinal

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Copyright Notice

Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK501905PMID: 30000965

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