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EU health authorities' calling of ashwagandha's safety into question is, in part, based on a misrepresentation of AHP's position on the botanical.
July 1, 2024
By: Mike Montemarano
In response to Danish and several European Health Authorities’ concerns that ashwagandha might possess abortifacient activity, the American Herbal Pharmacopoeia (AHP) has responded to citations of a WHO monograph which cited AHP’s 2000 “Ashwagandha Root Monograph and Therapeutic Compendium,” claiming that its position was misrepresented – and that ashwagandha shows no documented pregnancy risk.
In 2023, Denmark’s health authorities banned ashwagandha supplements, stating that it was impossible to establish a safe dose due to potentially harmful effects on hormones and potential abortifacient activity.
According to AHP, the 2009 WHO monograph didn’t fully articulate AHP’s review on ashwagandha.
The WHO monograph stated the following:
“There are conflicting reports regarding the use of ashwagandha in pregnancy. Large but undefined doses have been reported to possess abortifacient activity (Chadha 1976; Svoboda 1992). Of several ayurvedic practitioners consulted, none reported having observed an abortifacient activity clinically. Conversely, ashwagandha has, traditionally and in modern ayurvedic practice, been used to prevent miscarriage and stabilize the fetus (Tirtha 1998).”
“Misrepresentation of the AHP monograph has been repeatedly uncritically resulting in the misconception that ashwagandha root is potentially unsafe,” AHP stated.
The first edition of the “Botanical Safety Handbook”provided a safety classification for ashwagandha of 2b, which is “not to be used in pregnancy unless otherwise recommended by a qualified health care practitioner, and a ‘notice’ as an abortifacient. That ‘notice’ was removed in the second edition of the “Botanical Safety Handbook” due to a lack of documentation.
Since these earlier publications, a review of traditional and scientific literature and all accessible citations that made any mention of ashwagandha as an abortifacient was conducted, AHP reported, and the opinion of Ayurvedic medicine practitioners was solicited.
Neither the expert advisory council for the “Botanical Safety Handbook” or experts involved in the AHP revision reported to find any traditional or scientific documentation that ashwagandha can cause abortion, and that earlier cautions were based on anecdotal reports from ethnobotanical literature. The overwhelming majority of these reports were based on the rarely-used aerial parts of the ashwagandha plant, and no pharmacological mechanisms of action have been established for the plant that would indicate abortifacient potential.
According to AHP, the Indian government’s Ministry of AYUSH also released a safety dossier this year noting the lack of abortifacient activity of ashwagandha root, which cited all clinical and preclinical data that have investigated the use of ashwagandha and its preparations in pregnancy. An animal study found no observed adverse effect levels of ashwagandha extract at concentrations of 2,000 mg/kg body weight, and available human trials reported no maternal or fetal toxicity in pregnant women.
“While adequate caution when using any substance during pregnancy is warranted, based on a critical and comprehensive review of the traditional and modern literature, as well as the opinion of the majority of experts, there is no evidence of an abortifacient effect of ashwagandha root,” AHP stated.
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