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\n Anaphylaxis associated with Andrographis can be \u2018rapid and unpredictable\u2019, the TGA warns.
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\n News<\/p>\n
\n An RACGP expert has welcomed a TGA\u00a0proposal\u00a0to remove\u00a0Andrographis\u00a0as a\u00a0permitted ingredient in listed medicines.
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\n Anaphylaxis associated with Andrographis can be \u2018rapid and unpredictable\u2019, the TGA warns.
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newsGP weekly poll
\n The\u00a0Therapeutic Goods Administration (TGA)\u00a0has proposed\u00a0the removal of\u00a0Andrographis paniculata\u00a0(Andrographis) from\u00a0a\u00a0list of permitted ingredients in listed medicines,\u00a0following ongoing\u00a0reports of anaphylaxis.
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\nAndrographis is found in a range of herbal medicines\u00a0for relief of colds\u00a0and flu,\u00a0and\u00a0as a listed medicine, it\u00a0can be\u202fpurchased\u202fat pharmacies,\u202fsupermarkets\u202fand health food stores without a prescription.
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\nHowever, the\u00a0ingredient\u00a0has\u00a0come under close watch from the TGA\u00a0following\u00a0concerns over\u00a0anaphylaxis, with a\u00a0safety\u00a0review undertaken in\u00a02015 and a requirement in\u00a02019\u00a0for\u00a0medicines\u00a0containing\u00a0Andrographis\u00a0to\u00a0carry a\u00a0warning\u00a0label\u00a0for\u00a0risk of allergic reaction.
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\nNow, an\u00a0updated safety review\u00a0released by\u00a0the TGA<\/a>\u00a0suggests\u00a0that despite\u00a0steps to increase safety,\u00a0the regulator has\u00a0\u2018continued to receive a sustained number of reports of anaphylaxis associated with Andrographis\u2011containing medicines, with no indication of a declining trend\u2019.
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\nAs of\u00a031 December 2024,\u00a0the\u00a0TGA\u00a0said\u00a0it had\u00a0received\u00a0reports of\u00a01217 adverse events related to medicines containing\u00a0Andrographis. And in latest figures up\u00a0to\u00a031 December 2025,\u00a0there had been\u00a0287 reports of anaphylaxis, including one fatal case in 2024.
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\nOf\u00a0further concern\u00a0is that anaphylaxis associated with Andrographis can be\u00a0\u2018rapid and unpredictable\u2019\u00a0\u2013\u00a0it\u00a0can occur on first use or after\u202fprevious\u202funeventful use, even in people with no history of allergies.
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\n\u2018Symptoms can appear within 30 minutes of taking the medicine and often require urgent medical treatment,\u2019 the\u00a0safety review states.
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\nThe\u00a0TGA\u00a0states\u00a0that for\u00a0an ingredient to remain\u00a0appropriate for\u00a0use in low-risk listed medicines\u00a0available from retail outlets,\u00a0\u2018it should be safe for self-administration without the need for medical advice or supervision\u2019.
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\n\u2018As the risk of life-threatening anaphylaxis cannot be predicted or reliably mitigated, and with a sustained high number of reports of anaphylaxis involving Andrographis-containing listed medicines since 2019, this ingredient is inconsistent with the low-risk medicines regulatory framework.\u2019
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\nThe idea of introducing\u00a0stronger label warnings, formulation restrictions or further education\u00a0was rejected by the TGA review as\u00a0effective options to reduce the risk.
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\n\u2018This updated safety review has concluded that even if additional risk mitigation strategies were adopted, the risk of life-threatening anaphylaxis associated with Andrographis is inconsistent with the low-risk regulatory framework of listed medicines.\u2019
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\nChair\u00a0of the RACGP Expert Committee \u2013 Quality Care, Professor Mark Morgan\u00a0supports\u00a0the\u00a0TGA\u2019s proposal.
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\n\u2018With any medication decision there is always a balance of harms or risks against benefits.\u00a0The evidence of benefits for Andrographis to relieve cold and flu symptoms is limited,\u2019 he\u00a0told\u00a0newsGP.
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\n\u2018I agree with the TGA\u2019s approach to remove\u00a0Andrographis\u00a0from permitted ingredients.\u2019
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\nProfessor Morgan also suggested\u00a0GPs be aware of the concerns\u00a0around\u00a0Andrographis.
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\n\u2018If a patient describes anaphylaxis symptoms, this awareness might help the hunt for a trigger for the symptoms,\u2019 he said.
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\nA spokesperson for the TGA also\u00a0recommended\u00a0GPs\u00a0help patients understand the risks\u00a0of taking products containing\u00a0Andrographis and advise patients accordingly. This includes educating patients on the\u00a0signs of anaphylaxis\u00a0as well as what to\u00a0do if an\u00a0allergic reaction occurs.
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\nAs well as a rapid onset of symptoms,\u00a0it\u00a0is\u00a0important to note that\u00a0\u2018a viral\u00a0illness can increase the likelihood or severity of an allergic reaction,\u2019 the spokesperson said.
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\n\u2018Consumers and health professionals are also encouraged to report any suspected problems with Andrographis, as this will\u00a0assist\u00a0with the TGA\u2019s monitoring of these products.\u2019
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\nThe TGA has invited stakeholders, including\u00a0patient\u00a0associations, health professionals, medicine\u202fsponsors\u202fand industry peak bodies\u00a0to provide feedback on the proposed removal of Andrographis from the permitted ingredients list.\u00a0\u00a0
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\nUpdated safety advice\u00a0can be access via the\u00a0TGA website<\/a>.
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\nLog in below to join the conversation.
\n<\/p>\n
\n anaphylaxis<\/a> Andrographis<\/a> medicine safety<\/a> medicines regulation<\/a> TGA<\/a> Therapeutic Goods Administration<\/a>
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News
An RACGP expert has welcomed a TGA\u00a0proposal\u00a0to remove\u00a0Andrographis\u00a0as a\u00a0permitted ingredient in listed medicines.
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