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Australia considers requiring new warning statements for medicines containing andrographis herb

  • Australia considers requiring new warning statements for medicines containing andrographis herb

    by Market Insider

    Friday, 11 Dec. 2015

    Andrographis herb (Andrographis paniculata), known as ‘kalmegh’ in the Indian systems of medicine and as ‘chuanxinlian’ in Chinese medicine, is a product of Southern Asian biodiversity, native to parts of the Republic of India and Democratic Socialist Republic of Sri Lanka. The material of commerce is, for the most part, wild collected in India but also cultivated there, as well as in other countries where the species has been introduced and naturalized such as in the People’s Republic of China, Malaysia, Republic of Indonesia, Republic of the Union of Myanmar, and Kingdom of Thailand.

    In India, andrographis is found growing in the “Middle Gangetic Plains Region” (states of Bihar and Uttar Pradesh); the “Upper Gangetic Plains Region” (Uttar Pradesh and Delhi); the “Eastern Plateau and Hill Region” (Bihar, Orissa, and Madhya Pradesh); the “Central Plateau and Hill Region” (Madhya Pradesh, Uttar Pradesh, and Rajasthan); and the “East Coast Plains and Hill Region” (Orissa, Andhra Pradesh, and Tamil Nadu).

    The Australian Register of Therapeutic Goods (ARTG) shows that there are presently 75 Andrographis-containing listed medicines marketed in Australia. In October 2015, the Australian Government Therapeutic Goods Administration (TGA) issued a safety advisory for listed medicines containing Andrographis paniculata:

    “Consumers and health professionals are advised that, following a safety review of Andrographis paniculata (A. paniculata), the TGA has found a potential risk of allergic reactions, including severe allergic reactions such as anaphylaxis, associated with the use of products containing this herbal ingredient.”

    Accompanying the TGA safety advisory was the publication of a 29-page safety review report which concluded:

    “The number of anaphylactic / allergic-type adverse drug reactions (ADRs) reported and the severity of the ADRs suggests that the ingredient A. paniculata presents a potential risk significant to warrant further action, particularly considering that A. paniculata containing products are available over the counter and are regulated as low risk (listed) medicines. The TGA is considering the most appropriate regulatory action, including the requirement for warning statements on the labels of medicines containing A. paniculata, and will continue to monitor and review ADRs reported for these products to assess the effectiveness of any introduced risk mitigation strategies.”

    Sources:

    1. Therapeutic Goods Administration (TGA). Safety review of Andrographis paniculata and anaphylactic / allergic reactions. Version 1.0, October 2015. Woden, Australia: Australian Government Department of Health TGA. Available at: https://www.tga.gov.au/sites/default/files/safety-review-andrographis.pdf

    2. Therapeutic Goods Administration (TGA). Safety advisory - risk of allergic reactions: Products containing Andrographis paniculata. Woden, Australia: Australian Government Department of Health TGA. 08 October 2015. Available at: https://www.tga.gov.au/alert/products-containing-andrographis-paniculata

    3. Engels G, Brinckmann J. Andrographis - Andrographis paniculata - Family: Acanthaceae. HerbalGram The Journal of the American Botanical Council. 2015;105:1-5.

    4. National Medicinal Plants Board. State Wise Natural Habitat of the Prioritized Species. New Delhi, India: Government of India, National Medicinal Plants Board, Ministry of AYUSH.

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