MEDSAFE (NZ Medicines and Medical Devices Safety Authority) issued an alert regarding Andrographis paniculata and potential risk for allergic reactions in March 2017. 

Natural health products are currently not assessed or reviewed by MEDSAFE, however they have alerted consumers of potential risk.

In Australia, there are currently no restrictions or label warnings required for the use of products which include Andrographis paniculata  listed on the Australian Register of Therapeutic Goods (ARTG).

Between December 2002 and April 2014, the Therapeutic Goods Administration (TGA) received 43 reports of anaphylaxis and 78 reports of other allergic-type reactions associated with products that contain Andrographis paniculata.

The TGA continually monitors therapeutic goods supplied in Australia to ensure their ongoing safety, efficacy and quality.  As part of this process, the TGA routinely undertakes safety reviews of therapeutic goods.

The TGA published a safety review  of Andrographis paniculata in 2015, the TGA safety review included analysis of the above reports, indicating Andrographis paniculata might cause or play a contributing role in these adverse reactions.

This issue was discussed at the Advisory Committee on the Safety of Medicines July 2014, (ACSOM) which considered the information and provided advice regarding potential actions to reduce the risk.  ACSOM Meeting 23 meeting statement 

The committee advised that while further statistical analysis would be beneficial, taking account of the heterogeneity of the products and preparation methods, there is still sufficient information currently available to confirm an association between anaphylactic / allergic-type reactions and the herbal ingredient Andrographis paniculata and that this is more likely in products with higher concentrations of active ingredients obtained using the methanol extraction method.

The TGA is now considering whether any further action is required, and in the meantime will continue to monitor products containing Andrographis.  The TGA has been advised to initially undertake a safety review on the effects on pregnancy and lactation, and any need for a specific warning.

Conclusion

Considerations to be taken when prescribing Andrographis paniculata include:

• Product quality, appropriate dosing and duration to minimise potential ADRs.
• Avoid sudden excessive dosing.
• Awareness of the potential effects is advised.
• Monitor patient for any potential allergic reactions or symptoms which may indicate an allergic reaction