Is lagundi (Vitex negundo) safe for use during pregnancy?

Is Lagundi Safe for Pregnancy?

Lagundi (Vitex negundo) should not be used during pregnancy due to the complete absence of human safety data and the lack of regulatory approval or guideline support for its use in pregnant women.

Evidence Assessment

Absence of Clinical Safety Data

• No human studies have evaluated the safety of Vitex negundo during pregnancy, and it is not mentioned in any major obstetric or allergy guidelines 1.
• A systematic review of herbal medicines used in Asian countries during pregnancy did not provide specific safety classification for lagundi, highlighting the general lack of information on herbal medicine safety in pregnancy 2.
• The broader literature on herbal medicines in pregnancy emphasizes that "herbs contain a number of active substances that, when used during pregnancy, can affect the development of the fetus" 3.

Animal and Preclinical Data

• While one animal study demonstrated that Vitex negundo has antitussive (cough-suppressing) effects in mice with an LD50 greater than 5000 mg/kg and no acute neurotoxicity at therapeutic doses, this study was not designed to evaluate reproductive toxicity or teratogenicity 4.
• The absence of developmental toxicity studies means we cannot extrapolate safety to pregnancy, even though the plant showed no acute toxicity in adult animals 4.

Regulatory Framework for Pregnancy Medications

• The FDA pregnancy risk classification system requires either adequate human studies or reassuring animal reproductive studies to establish safety 1.
• Medications lacking definitive human safety data should only be used "when the expected maternal benefit justifies the potential fetal risk" 5.
• Lagundi has neither human pregnancy data nor animal reproductive toxicity studies, placing it in a category where use cannot be justified for common respiratory symptoms 1, 5.

Safer Alternatives for Respiratory Symptoms in Pregnancy

First-Line Non-Pharmacologic Approaches

• Adequate hydration, humidified air, and saline nasal irrigation are recommended as initial therapy for upper respiratory symptoms 5.
• These measures carry no fetal risk and should be maximized before considering any medication 5.

Evidence-Based Pharmacologic Options

If medication becomes necessary for respiratory symptoms:

• Intranasal corticosteroids (budesonide, FDA Category B) have robust safety data and are preferred for nasal congestion 1, 5.
• Sodium cromolyn (Category B) is considered safe for managing respiratory symptoms during pregnancy 1, 5.
• First-generation antihistamines like promethazine have been confirmed safe in large birth registries with no increased risk of congenital malformations 6.

Cough Management

• For productive cough, guaifenesin may be considered in the second or third trimester at the lowest effective dose, though it should be avoided in the first trimester when possible 5.
• Single-ingredient products should be used; combination products with decongestants carry additional malformation risks 1, 5.

Critical Caveats

The "Natural = Safe" Fallacy

• Herbal products are "frequently considered as natural and therefore harmless," but this assumption is dangerous during pregnancy 3.
• Many pregnant women do not consult physicians about herbal medicine use, creating unrecognized risks 3.

Lack of Quality Control

• Unlike FDA-approved medications, herbal products lack standardized dosing, quality control, and safety monitoring 2, 3.
• The active constituents and their concentrations can vary significantly between preparations 3.

First Trimester Vulnerability

• The period of organogenesis (first trimester) is when teratogenic risks are highest, and any unproven substance should be strictly avoided during this window 6.

Given the availability of well-studied, guideline-supported alternatives for respiratory symptoms in pregnancy, there is no justification for using lagundi, which carries unknown fetal risks 1, 5, 2, 3.