In late 2002, following a report in the medical journal, the Lancet, concerns arose regarding a possible association between the herb Chelidonium majus (Greater celandine) and liver problems. Greater celandine, or Chelidonium, has been traditionally used to treat a range of conditions including disorders of the liver and is widely available internationally. The TGA prepared a preliminary safety review on the herb for the May 2003 meeting of the Complementary Medicines Evaluation Committee (CMEC) following which a precautionary notice was included on this website. A more complete safety review of the herb undertaken by the TGA has now been considered by the CMEC at its most recent meeting held on 1 August 2003.
The CMEC 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. The Committee concluded that the mechanism underlying the hepatotoxic effect remained to be elucidated 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.
On the basis of its deliberations, the CMEC has recommended that the TGA maintain Chelidonium majus as a listable substance, but that oral products be required to include a label warning statement. The statement is 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 will consider the CMEC's recommendation and in the meantime advises anyone who experiences any unexplained symptoms while taking or after using a Chelidonium-containing medicine to seek medical advice. The TGA also advises healthcare practitioners to be on the lookout for signs of liver toxicity associated with the use of Chelidonium-containing medicines. Health professionals are asked to report any suspected adverse reactions thought to be associated with Chelidonium majus (greater celandine) to the Adverse Drug Reactions Unit at the TGA using the postage pre-paid blue card or on 1800 044 114 or using the electronic reporting form.