Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)

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Download document Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
Reference number EMA/HMPC/893108/2011 2nd draft
Status draft: consultation open
First published 14/11/2013
Last updated 14/11/2013
Consultation start date 14/11/2013
Consultation end date 15/02/2014
Email address for submissions hmpc.secretariat@ema.europa.eu

Summary

It became apparent during assessment of Symphytum officinale (monograph EMEA/HMPC/572844/2009) that the risk assessment of pyrrolizidine alkaloids (PAs) poses considerable difficulties, with several PAs being regarded as both hepatotoxic and carcinogenic. Considering that PAs are natural constituents of a number of plants used for medicinal purposes and that PAs might be part of the food chain, the HMPC decided to prepare a public statement on the use of herbal preparations containing PAs.