24 March 2017
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.
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.
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.
| Phone | + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM) |
| Online |
Submit a
report
to CARM Prescribers can submit using the online reporting tool available in patient management software |
| Yellow Card | A completed Yellow card can be submitted to CARM via email, fax or mail |
| carmnz@otago.ac.nz | |
| Fax | +64 3 479 7150 |
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.
More information on the cases in Australia and the TGA’s safety review can be found at: www.tga.gov.au/alert/products-containing-andrographis-paniculata
www.tga.gov.au/alert/safety-review-andrographis-paniculata-and-anaphylacticallergic-reactions
