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St. John’s Wort product recall due to pyrrolizidine alkaloid contamination

  • St. John’s Wort product recall due to pyrrolizidine alkaloid contamination

    by Market Insider

    Friday, 12 Feb. 2016

    St. John’s wort (Hypericum perforatum) is a native plant of European, northern African and western Asian biodiversity. The flowering tops are harvested (from both wild-collection and controlled cultivation) during the flowering period for use in European herbal medicinal products but are also exported for use in medicinal products worldwide.

    On 08 February 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) in London took a precautionary step of recalling six specific batches of registered traditional herbal medicinal products (THMPs) containing dry extract of St John’s Wort aerial parts due to contamination by pyrrolizidine alkaloids (PAs) above the threshold recommended by the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA).

    For names of the affected products and batch numbers see MHRA press release at: https://www.gov.uk/government/news/precautionary-recall-six-batches-of-st-johns-wort-tablets

    St. John’s wort does not naturally contain PAs. The detection of PAs in St. John’s wort products is likely accidental due to other PA-containing wild plants getting mixed in during harvesting. A 2015 report by the European Food Safety Authority (EFSA) found that St. John’s wort products are frequently contaminated with PAs and appear to be most often contaminated with traces of plant material from species of the Boraginaceae family or the Eupatorium genus.

    In Europe, the commercial supply of St. John’s wort (flowering aerial parts) is for the most part obtained from producers and suppliers in the Republic of Albania, Republic of Austria, Bosnia & Herzegovina, Republic of Bulgaria, Republic of Croatia, Federal Republic of Germany, Hungary, Republic of Italy, Kosovo, Republic of Poland, Romania, Republic of Serbia, and the former Yugoslav Republic of Macedonia.

    In the European Union, certain preparations containing dry extract of St. John’s wort for oral administration can be granted marketing authorization and labelled for relief of temporary mental exhaustion.

    Sources:

    1. Medicines and Healthcare products Regulatory Agency (MHRA). Six batches of St John’s Wort Tablets containing 91,800 packs are being recalled today as a precaution because of product contamination. London, MHRA. 8 February 2016: https://www.gov.uk/government/news/precautionary-recall-six-batches-of-st-johns-wort-tablets
    2. Mulder PPJ, López Sánchez P, These A, Preiss-Weigert A and Castellari M, 2015. Occurrence of Pyrrolizidine Alkaloids in food. EFSA supporting publication 2015:EN-859, 114 pp: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/859e.pdf
    3. European Medicines Agency (EMA) Committee on Herbal Medicinal Products (HMPC). Final Community Herbal Monograph on Hypericum perforatum L., Herba (Traditional Use). London, UK: EMA. 12 November 2009: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2010/01/WC500059149.pdf

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