Safety Information

Published: 9 May 2018

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Life-threatening severe allergic reaction (anaphylaxis) to Calocurb dietary supplement

7 May 2018

The Centre for Adverse Reactions Monitoring (CARM) has received a report of a severe allergic reaction (anaphylaxis) to the dietary supplement Calocurb. The reaction was life-threatening and is the first report received by CARM since this product entered the New Zealand market in April.

The report described initial symptoms of abdominal discomfort and red and itchy hands after the patient’s third dose of Calocurb.  The symptoms continued worsening to the point of losing consciousness. Admission to hospital was required where anaphylaxis was diagnosed. 

Products Affected

Calocurb is a dietary supplement marketed to support weight loss and appetite control. It contains an extract of New Zealand grown hops called Amarasate. This extract is in combination with a rosemary leaf extract and canola oil inside a capsule for oral administration.

Advice

The exact composition of dietary supplements such as Calocurb is unknown. Each individual capsule may vary in composition of components and allergic reactions may be a response to any component.

Dietary supplements are not evaluated for safety, efficacy and quality by Medsafe. These products can cause severe adverse reactions such as anaphylaxis and other reactions in some people. Your healthcare professional is the best person to talk to about any dietary supplement to discuss if it is a safe and appropriate option for you.

Always tell your pharmacist or doctor about any dietary supplements you are taking and discuss any concerns with them. 

You can also read about severe allergic reactions (anaphylaxis) in English and Te Reo (Ko Ngā Tauhohenga Mate Pāwera (Anaphylaxis) ki Ngā Rongoā

Regulator Actions

Medsafe continues to monitor reports of adverse reactions to Calocurb and all other dietary supplements.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring.

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