Withania TGA Alert: Herb Information from Phytomed

   

Withania somnifera (ashwagandha) - the new TGA alerts
 

TGA, the Australian Therapeutic Goods Administration, recently issued a safety advisory warning for the use of Withania somnifera (ashwagandha). It was a preliminary notice while it undertakes a more formal review and evaluation and as a safety precaution. It may ultimately result in a formal requirement to include a warning along the lines of ‘in a few and rare cases, Withania somnifera (ashwagandha) may result in liver injury.’

It has been issued against a background of a few cases of gastrointestinal side effects reported, relating to Withania somnifera (ashwagandha). For safety purposes it has classified these as ‘adverse events’. The TGA has received reports suggesting there may be a very rare link to liver injury, based on a very recent safety investigation¹.

The TGA has noted that some of the reports of liver damage were linked to products bought online from overseas sources. Other reports occurred while concomitant products or ingredients were being taken. At this stage it is not known whether the adverse events relate to the herb, or to the manufacturing process of the final product.

TGA Alerts for Withania somnifera (ashwagandha)

As with any raw material - sourcing, identification, sustainability and harvesting of the herb is paramount for the end therapeutic effect of the herb.  Ashwagandha has always been known as a plant with a long history of traditional use for a range of health benefits. It has been subject to many peer-reviewed randomised clinical trials (RCTs) as highlighted by Complementary Medicines Australia (CMA). The incidence of adverse events in these studies have historically been very low and reported predominantly in individuals with pre-existing conditions or concomitant medication.

The herb Withania somnifera has been extensively used clinically, as an adrenergic adaptogen, and a nervous system restorative for stress, anxiety, and sleep. This herb has been favoured for its high safety profile, dosing and actions, including immune modulating,anti-inflammatory, insomnia for chronic fatigue syndrome (CFC), post viral syndromes, and fibromyalgia.^2,3

Phytomed currently has three Withania somnifera liquid extract options within its product range. These includes a 1:1 glycetract, 1:2 hydroethanolic, and our recent, clinically researched and standardised 3:2 hydroethanolic. Our sourcing of ashwagandha is consistently obtained from a supplier with whom we have had a long-standing, and trusted relationship over several years. Our clinically researched Withania somnifera is sourced from a reputable and reliable supplier who specialises in proprietary and researched botanicals.

Importantly, Phytomed holds Good Manufacturing Practice (GMP) certification for ingredient and product manufacturing. With all our extracts, we follow and adhere to a consistent and high level of manufacturing quality standards.

We believe that herbal ingredients must be safe and suitable for use and have the desired therapeutic effect relevant for the consumer. This requires a healthy starting point, using raw materials that meet a high-quality specification, ensuring strict manufacturing controls, adopting sustainable harvesting practices, and using clinically researched active constituents or herbal material. This facilitates successful substantiation of products, appropriate claims, known contraindications, and the therapeutic properties of the end herbal product.

Phytomed, NZ

 

References

1. The Department of Health and Aged Care - Therapeutic Goods Advisory. Medicines containing Withania somnifera (Withania, ashwagandha) Safety advisory – potential for gastrointestinal symptoms and very rare cases of liver injury; 2024 Feb. Available from: https://www.tga.gov.au/news/safety-alerts/medicines-containing-withania-somnifera-withania-ashwagandha

 

2. Speers AB, Cabey KA, Soumyanath A, Wright KM. Effects of Withania somnifera (Ashwagandha) on Stress and the Stress- Related Neuropsychiatric Disorders Anxiety, Depression, and Insomnia. Current neuropharmacology. 2021; 19(9): 1468–1495. Available from: https://doi.org/10.2174/1570159X19666210712151556.

 

3. Della Porta M, Maier JA, Cazzola R. Effects of Withania somnifera on Cortisol Levels in Stressed Human Subjects: A Systematic Review. Nutrients. 2023; 15(24): 5015. Available from: https://doi.org/10.3390/nu15245015