Published: 7 May 2019

Safety Information

Monitoring

Review of the risks of harm and chance of benefit of Cafergot (ergotamine tartrate + caffeine) under section 36 of the Medicines Act 1981

7 May 2019

The Medicines Adverse Reactions Committee (MARC) discussed ta report of adverse reactions linked to the use of Cafergot (ergotamine tartrate + caffeine) on 14 March 2019. The Committee considered that the place for this medicine in the treatment of migraine had been superseded. The Committee recommended that a review of Cafergot under section 36 of the Medicines Act 1981 should be conducted.

Any patients who are concerned about their migraine treatment should talk to their doctor.

Additional Information

Section 36 of the Medicines Act 1981 allows the Director-General of health to review the efficacy and safety of a medicine. After notification, the manufacturer of the medicine has 60 days to respond.  The response is referred back to the Medicines Adverse Reactions Committee (MARC) who provides advice to the Minister on further actions. The outcome of the review include:

•  No action
•  Conditions on the use of Cafergot may be imposed
• The approval of the medicine may be discontinued.

Further information on the report presented to the MARC and their discussion will be published on the Medsafe website:

https://medsafe.govt.nz/profs/MARC/Minutes.asp

https://medsafe.govt.nz/committees/MARC/Reports.asp

Products Affected

Each Cafergot tablet contains 1 mg ergotamine tartrate and 100 mg caffeine. Cafergot is the only approved ergotamine-containing product in New Zealand. 

Cafergot is indicated for treatment of acute attacks of migraine with or without aura in adults.

Regulator Actions

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.