Translation of a-t 2025; 56: 71

YET AGAIN: ASHWAGANDHA AND LIVER DAMAGE

The Netherlands pharmacovigilance centre Lareb has issued a statement reporting of twelve patients with liver damage associated with the dietary supplement ashwagandha (Withania somnifera), also known as winter cherry or Indian ginseng, which is part of the nightshade family. It has received eight reports since September 2023, i.e. after the centre first warned of the risk (e a t 10/2023b).¹ In seven cases, the suspected product contained ashwagandha only, which is used in traditional Ayurvedic medicine and increasingly advertised in western countries as a dietary supplement. However, there is insufficient scientific evidence concerning the supposed health benefits, ² which include reducing stress and maintaining mental balance. We consider the claims made by one supplier that the European Food Safety Authority (EFSA) has approved or (highlighted by editorial staff) is reviewing statements concerning the effects of the supplement such as "ashwagandha ... helps reduce stress" or "supports normal respiratory function" to be outrageous.³ We consider this use of "or" to be misleading, as the EFSA has to date not approved any health claims for ashwagandha.

Herbal products are generally believed to be harmless.* There is no systematic information on any undesirable effects of ashwagandha – in part because clinical studies exploring this subject are lacking and because no systematic system for recording undesirable effects of dietary supplements has been established in Germany (see a-t 2025; 56: 56). The Federal Institute for Risk Assessment (BfR) has received three reports of suspected undesirable effects of ashwagandha, including one reporting liver enzymes five times the normal values, which were detected in a 20-year-old patient as part of a routine investigation.⁴ The reports from the Netherlands describe symptoms such as fatigue, weakness, nausea, lack of appetite, abdominal pain, itching and dark urine and jaundice which started between one week and months after starting to take ashwagandha. Other symptoms reported were diarrhoea and somnolence. There have been various reports of liver damage in the literature (1), including acute liver failure requiring a liver transplant.⁵ The Vigibase database of the World Health Organization (WHO) lists 21 suspected reports of hepatobiliary events with Withania somnifera.⁶

The mechanism by which it causes harm is not known. One of the suspected pathways being discussed is damage to hepatocellular DNA through irreversible binding of withanolides**.^1,7,8

The BfR recommends that pregnant and breastfeeding women, children and patients with a history of liver disease avoid ashwagandha.² We believe ashwagandha to have a negative benefit-risk ratio and generally advise against its use as a precautionary measure to protect consumers, –Ed.

©  arznei-telegramm (Berlin/Germany), September 2025, protected by copyright laws.