Products containing Andrographis paniculata

Consumers and health professionals are advised that, following a safety review of Andrographis paniculata (A.paniculata), the TGA has found a potential risk of allergic reactions, including severe allergic reactions such as anaphylaxis, associated with the use of products containing this herbal ingredient.

A.paniculata is a herbal ingredient used in some complementary medicines. It belongs to the Acanthaceae family and is indigenous to India, Ceylon, and Java. A.paniculata is also known as kalmegh and green chiretta in Ayurvedic medicine, and chuanxinlian in traditional Chinese medicine.

A.paniculata has been used traditionally to:

• relieve fever
• relieve the symptoms of colds
• alleviate sore throats
• alleviate gastro-intestinal upsets and acute diarrhoea
• aid recovery from mild respiratory tract infections.

Products that include A.paniculata are listed on the Australian Register of Therapeutic Goods (ARTG) with a wide range of indications.

There are currently no restrictions or label warnings required for the use of A.paniculata in medicines in Australia.

Between December 2002 and April 2014, the TGA received 43 reports of anaphylaxis and 78 reports of other allergic-type reactions associated with products that contain A.paniculata.

The TGA safety review, which included analysis of the above reports, indicated that A.paniculata might cause or play a contributing role in these adverse reactions, including when used in multi-ingredient formulations.

This issue was also referred to the Advisory Committee on the Safety of Medicines, (ACSOM) which considered the information and provided advice regarding potential actions to reduce the risk. Details of this advice were published in the ACSOM Meeting 23 meeting statement on the TGA website.

The TGA is now considering whether any further action is required, and in the meantime will continue to monitor products containing A.paniculata.

Information for consumers

Consumers are advised that, while use of products listed on the ARTG containing A.paniculata is usually safe, there is a potential risk of allergic reactions, including severe allergic reactions such as anaphylaxis, associated with these medicines.

If you use a medicine that contains A.paniculata and suspect that you are experiencing any signs or symptoms of an allergic reaction, stop using the product and consult a health professional.

Signs and symptoms of severe allergic reactions can include one or more of the following:

• hives or welts (a red, itchy, lumpy rash, like mosquito bites)
• a tingling feeling in or around the mouth
• stomach pain, vomiting and/or diarrhoea
• facial swelling
• difficulty with breathing and/or noisy breathing
• swelling of the tongue
• swelling and/or tightness in throat
• difficulty talking and/or hoarse voice
• loss of consciousness and/or collapse.

If you have any questions or concerns about these medicines, talk to a health professional.

Information for health professionals

If a patient you are treating is taking a product that contains A.paniculata advise them of the signs and symptoms of an allergic reaction. Instruct them to stop using the product and consult a health professional if they suspect that they are experiencing any of those symptoms.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.