Safety Information

Early Warning System - Alert Communication

Andrographis paniculata – potential risk for allergic reactions

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
Review Summary
What actions are Medsafe taking?
How to report adverse events
Further information

Andrographis paniculata is a herb included in some natural health products. These products are used by consumers who believe they support a healthy immune system, support recovery from the common cold and help with symptoms of the cold.

Consumers should be aware of the potential risk for serious allergic reactions with products containing andrographis.

Information for consumers and caregivers

Andrographis-containing products have the potential to cause serious allergic reactions. Check the listed ingredients in natural health products before use.
Stop taking the product if you experience any signs or symptoms of an allergic reaction such as rash, shortness of breath/difficulty breathing, or swelling of the tongue or face.
Seek immediate medical attention if you experience a serious allergic reaction, for example at the emergency department of your local hospital.
Talk to your healthcare professional if you have any concerns.
Report any adverse reactions to andrographis-containing products to the Centre for Adverse Reactions Monitoring (CARM). Reports can be submitted online at https://nzphvc.otago.ac.nz/. Please see below for other ways to report adverse events.

Information for healthcare professionals

Serious allergic reactions such as anaphylaxis are possible with andrographis-containing products.
Alert patients to the signs and symptoms of serious allergic reactions such as rash, shortness of breath/difficulty breathing, facial swelling or loss of consciousness. Inform patients to seek immediate medical attention if they experience any of these symptoms.
Advise patients not to take products containing andrographis in the future if they experience an allergic reaction.
Report the adverse event to the Centre for Adverse Reactions Monitoring (CARM). Reports can be submitted online at https://nzphvc.otago.ac.nz/. Please see below for other ways to report adverse events to CARM.

Data Summary

In New Zealand, a number of cases have been identified by Centre for Adverse Reactions Monitoring (CARM) which reported allergic reaction in consumers taking andrographis-containing products. The reported reactions include dyspnoea, flushing, urticaria and anaphylaxis.

Similar reports have been noted internationally. Between December 2002 and April 2014, the Therapeutic Goods Administration (TGA) in Australia received 43 reports of anaphylaxis and 78 reports of other allergic-type reactions associated with products that contain andrographis.

The World Health Organization’s (WHO) global Individual Case Safety Report database (VigiBase) contains 198 reports related to andrographis. Of these reports, 147 reports involved hypersensitivity reactions such as urticaria, pruritus, anaphylactic reactions, eyelid oedema, face oedema and angioedema. These reports were submitted by member countries of the WHO Programme for International Drug Monitoring.

What actions are Medsafe taking?

Natural health products are currently not assessed or reviewed by Medsafe. Consumers and healthcare professionals are reminded that products containing andrographis have the potential to cause serious allergic reactions.

How to report adverse events

Online	Submit a CARM report Prescribers can also submit a report using the online reporting tool available in patient management software.
Paper	Download a consumer reporting form (Word Document, 61KB, 1 page) Download a healthcare professional reporting form (PDF, 292 KB, 2 pages) Submit completed forms by emailing CARMreport@health.govt.nz or mail (Medsafe, Ministry of Health, 133 Molesworth Street, Thorndon, Wellington, 6011).
Email	CARMreport@health.govt.nz

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.