Listed medicines containing Andrographis paniculata requiring warning statements

In 2022, we initiated targeted compliance reviews of selected listed medicines that required warning statements if they contained the herbal ingredient Andrographis paniculata.

What led to this review?

Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows us to determine the compliance of these medicines with relevant regulatory requirements.

Listed medicines are only permitted to contain low risk ingredients from a pre-approved list. Although these ingredients are considered low-risk to the general adult population, some ingredients still require warning statements to alert consumers of potential unwanted side effects.

One tool that we use to ensure the safety of listed medicines is by using warning statements on the medicine label. Medicines that contain Andrographis paniculata require the following two warning statements:

• ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention.’ (or words to that effect).
• ‘Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice.’ (or words to that effect)

The absence of these warning statements may result in consumers delaying medical attention or advice.

What did we do?

A selection of (21) listed medicines that contained Andrographis paniculata were identified for review. We asked the sponsors of these medicines to provide the labels that were being used for these medicines to check the presence of the warning statements.

What did we find?

The sponsors of all 21 medicines (100%) responded to our request for information, of which 14 medicines (67%) were found to include the required warning statements. The compliance status of 2 medicines could not be determined as they were never manufactured.

Of the 5 medicines (24%) that were found to be missing one of the required warning statements:

• 2 were recalled;
• one was cancelled from the ARTG by the TGA; and
• one sponsor was given an infringement notice for repeatedly failing to include required warning statements on their medicine labels.

The compliance review results for each medicine are published on the page Listed medicine compliance reports.

Information for sponsors

If you are the sponsor of a listed medicine, you should:

• review the ingredients used in your medicine to ensure that any requirements and warning statements listed in the Therapeutic Goods (Permissible Ingredients) Determination are complied with
• be aware that missing warning statements on medicine labels may result in recall of non-compliant stock
• be aware that the requirements for ingredients in the Therapeutic Goods (Permissible Ingredients) Determination can change from time to time. It is the sponsor’s responsibility to make sure that these changes are implemented to their medicine, and within the transition period if applicable
• be aware that repeatedly failing to comply with legislative requirements, such as not including the required warning statements on the label, could result in higher-level enforcement actions, including infringement notices or other penalties.