CMA have advised that the Therapeutic Goods Administration’s Pharmacovigilance and Special Access Branch (PSAB) will be undertaking a safety review of the allergenicity of Echinacea species (Echinacea angustifolia, E. pallida and E. purpurea).
This issue has been previously considered by the TGA and ongoing monitoring has identified publications that refer to the allergenicity of Echinacea species, such as alerts by international regulatory agencies, for example UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the Irish Medicines Board (IMB). The current review will serve to update previous work undertaken by the TGA.
Sponsors should note that as part of this investigation, PSAB will be requesting information on adverse reactions reported to sponsors in relation to listed medicines containing Echinacea species.