Incidence of Pyrrolizidine Alkaloids in Herbal Medicines from German Retail Markets: Risk Assessments and Implications to Consumers

Phytotherapy Research

Volumn 31, Issue 12, 2017, Pages 1903-1909

  Letsyo, Emmanuel ^a   Jerz, Gerold ^a   Winterhalter, Peter ^a   Lindigkeit, Rainer ^a   Beuerle, Till ^a  

^a TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

Author keywords

Cynara cardunculus; Europe; herbal medicine; HPLC ESI MS MS; Hypericum perforatum (St. John's Wort); pyrrolizidine alkaloid

Indexed keywords

HERBACEOUS AGENT; PYRROLIZIDINE ALKALOID;

ARTICLE; CARDOON; DRUG CONTAMINATION; DRUG QUALITY; DRUG SAFETY; ECHIUM; GENTIANA LUTEA; GERMANY; HYPERICUM PERFORATUM; LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY; PHARMACY; PRIMULA; PRIMULA VERIS; RISK ASSESSMENT; RUMEX ACETOSA; SAMBUCUS NIGRA; SENECIO; URTICA DIOICA; VERBENA OFFICINALIS; CHEMISTRY; HERBAL MEDICINE; HUMAN; HYPERICUM; INCIDENCE; PROCEDURES;

GERMANY; HERBAL MEDICINE; HUMANS; HYPERICUM; INCIDENCE; PYRROLIZIDINE ALKALOIDS; RISK ASSESSMENT;

EID: 85033586105     PISSN: 0951418X     EISSN: 10991573     Source Type: Journal    
DOI: 10.1002/ptr.5935     Document Type: Article

References (30)

1. Australia New Zealand Food Authority (2001). Pyrrolizidine alkaloids in food. Technical Report Series No. 2.
2. Bundesinstitut für Risikobewertung/German Federal Institute for Risk Assessment (2013). Pyrrolizidine alkaloids in herbal teas and teas. Opinion_no._018/2013_of_5July_2013._ Available from http://www.bfr.bund.de/cm/349/pyrrolizidine-alkaloids-in-herbal-teas-and-teas.pdf (last accessed 07.08.2017)
3. Blumenthal M, Busse WR, Hall T, et al. 1998. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Trans. S. Klein. Austin. American Botanical Council/Integrative Medicine Communications: TX/Boston, MA.
4. Cramer L, Beuerle T. 2012. Detection and quantification of pyrrolizidine alkaloids in antibacterial medical honeys. Planta Med 78: 1976–1982.
5. Cramer L, Schiebel HM, Ernst L, Beuerle T. 2013. Pyrrolizidine alkaloids in the food chain: development, validation, and application of a new HPLC-ESI-MS/MS sum parameter method. J Agric Food Chem 61: 11382–11391.
6. Dharmananda, S. (2007). Lycium fruit: food and medicine. Monograph on the internet. Available from http://www.itmonline.org/arts/lycium.htm (last accessed 07.08.2017).
7. Dübecke A, Beckh G, Lüllmann C. 2011. Pyrrolizidine alkaloids in honey and bee pollen. Food Addit Contam Part A 28: 348–358.
8. [EMA] European Medicines Agency (2016). Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids: transitional recommendations for risk management and quality control. EMA/HMPC/328782/2016 http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2016/06/WC500208195.pdf (last accessed 07.08.2017).
9. [EMA] European Medicines Agency (2006). Guideline on Good Agricultural and Collection Practices (GACP) for starting materials of herbal origin. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pdf (last accessed 07.08.2017).
10. [EMA] European Medicines Agency (2017). European Union monographs and list entries. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001132.jsp&mid=WC0b01ac0580033809 (last accessed 07.08.2017).
11. [ESCOP] European Scientific Cooperative on Phytotherapy (1999). ESCOP monographs on the medicinal uses of plant drugs: Exeter, UK.
12. German Federal Health Bureau. 1992. Bekanntmachung über die Zulassung und Registrierung von Arzneimitteln (Abwehr von Arzneimittelrisiken − Stufe II). Bundesanzeiger 111: 4805–4807.
13. Kempf M, Wittig M, Schönfeld K, Cramer L, Schreier P, Beuerle T. 2011. Pyrrolizidine alkaloids in food: downstream contamination in the food chain caused by honey and pollen. Food Additives & Contaminants Part A 28: 325–331.
14. Knöss W, Reh K, Bodemann S, Kirchner C, Stolte F, Wiesner J. 2014. Rechtliche Rahmenbedingungen. Pharmakon 2: 143–150.
15. Knöss W. 2014. Pflanzliche Arzneimittel – Monographien als Richtschnur. PZ 159: 42–47.
16. Letsyo E, Jerz G, Winterhalter P, Horn G, Beuerle T. 2016. Survey of pyrrolizidine alkaloids in seven varieties of Lappula squarrosa: An alternative source of heart-healthy vegetable oil. Phytochem Anal 27: 133–139.
17. Letsyo E, Jerz G, Winterhalter P, Beuerle T. 2017a. Toxic pyrrolizidine alkaloids in herbal medicines commonly used in Ghana. J Ethnopharmacol 202: 154–161.
18. Letsyo E, Jerz G, Winterhalter P, et al. 2017b. Pyrrolizidine alkaloids in floral honeys of tropical Ghana: a health risk assessment. Food Additives & Contaminants Part B. https://doi.org/10.1080/19393210.2017.1354336.
19. Liu FX, Salmon JW. 2010. Herbal medicine regulation in China, Germany, and the United States. Integrative Medicine 9: 54–61.
20. Mädge I, Cramer L, Rahaus I, Jerz G, Winterhalter P, Beuerle T. 2015. Pyrrolizidine alkaloids in herbal teas for infants, pregnant or lactating women. Food Chem 187: 491–498.
21. Market Insider (2016). Medicinal plants & natural ingredients. Market Insider Quarterly Bulletin. http://www.intracen.org/uploadedFiles/intracenorg/Content/Exporters/Market_Data_and_Information/Market_information/Market_Insider/Medicinal_plants/MI_Medicinal_Plants_2016_March.pdf (last accessed 07.08.2017).
22. Medicines and Healthcare products Regulatory Agency (2016). Precautionary recall six batches of St. John's Wort tablets. Press release. London, MHRA. 8 February 2016: https://www.gov.uk/government/news/precautionary-recall-six-batches-of-st-johns-wort-tablets. (last accessed 07.08.2017).
23. Mulder, P. P. J., López-Sánchez, P., These, A., Preiss-Weigert, A., & Castellari, M. (2015). Occurrence of pyrrolizidine alkaloids in food. EFSA supporting publication 2015: EN-859, 114 pp: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2015.EN-859/pdf (last accessed 07.08. 2017).
24. Ober D, Hartmann T. 1999. Homospermidine synthase, the first pathway-specific enzyme of pyrrolizidine alkaloid biosynthesis, evolved from deoxyhypusine synthase. Proc Natl Acad Sci U S A 96: 14777–14782.
25. Röder E. 1995. Medicinal plants in Europe containing pyrrolizidine alkaloids. Pharmazie 50: 83–98.
26. Schulz M, Meins J, Diemert S, et al. 2015. Detection of pyrrolizidine alkaloids in German licensed herbal medicinal teas. Phytomedicine 22: 648–656.
27. Steinhoff B. 2017. Letter to the Editor on the “Code of practice to prevent and reduce pyrrolizidine alkaloid contaminations of medicinal products of plant origin”. Journal of Applied Research on Medicinal and Aromatic Plants 4: 82–96.
28. Verheesen M. 2016. Pflanzliche Arzneimittel in Deutschland–aktuelle Marktzahlen. Zeitschrift für Phytotherapie 37: 16–18.
29. [WHO] World Health Organization (1999). WHO monographs on selected medicinal plants, Vol. 1, Geneva.
30. Zhou J, Ouedraogo M, Qu F, Duez P. 2013. Potential genotoxicity of traditional Chinese medicinal plants and phytochemicals: An Overview. Phytother Res 27: 1745–1755.