Greater celandine warning label proposed in Australia
include a warning label to consumers, Australia's Complementary
Medicines Evaluation Committee has advised.
Products containing the herb Chelidonium majus should include a warning label to consumers, advising them to seek advice from a healthcare professional before use, Australia's Complementary Medicines Evaluation Committee (CMEC) has advised.
Greater celandine, or Chelidonium, has been traditionally used to treat a range of conditions including disorders of the liver and is widely available internationally. However, concerns that it could be associated with liver problems, detailed in a Lancet report last year, led Australia's Therapeutic Goods Administration to require further evidence of its safety.
The CMEC said it examined all of the available evidence linking ingestion of C. majus with moderate to severe, reversible acute hepatitis in a relatively small number of individuals worldwide. It could not explain the mechanism underlying the hepatotoxic effect and that there were no data relating to types of preparation or doses administered that would enable any predictions to be made about the potential hepatotoxicity of individual products, it reported.
It has therefore recommended that oral products include a label warning statement to advise consumers to use products containing the herb under the supervision of a healthcare professional, to seek advice from a healthcare professional before commencing use if there is history of liver disease, and to discontinue use of the herb if particular symptoms occur.
The TGA is still considering the CMEC's recommendation. It has asked health professionals and consumers to report any suspected adverse reactions thought to be associated with herb to its Adverse Drug Reactions Unit.
