Published: 20 November 2019
Safety Information
Alert Communication
Consent to distribute Cafergot tablets (ergotamine tartrate 1 mg + caffeine 100 mg) will be prohibited under Section 36 of the Medicines Act 1981 on 1 May 2020
20 November 2019
The Minister of Health’s Delegate has written to the supplier to prohibit them from selling Cafergot in NZ from 1 May 2020 as the benefits from using this medicine no longer outweigh the risks of harm. This decision results from a risk benefit review of the Cafergot under section 36 of the Medicines Act 1981.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
- Cafergot will not be available in NZ from 1 May 2020.
- Talk to your doctor about alternative treatment options if you are currently taking Cafergot.
- Do not stop taking your medicine before talking to your doctor.
- Cafergot can cause serious effects on the heart and arteries, especially in older people.
- If you suspect you have had an adverse reaction to Cafergot or any other medicine, report it to the Centre for Adverse Reactions Monitoring (CARM). Please see below for how to report.
Information for healthcare professionals
- Review of Cafergot by the Medicines Adverse Reactions Committee (MARC) concluded that the benefits do not outweigh the risks and the consent for this medicine should be revoked.
- The MARC recommended a transition period of 6 months to enable that patients change to alternative treatment options in a safe manner.
- Discuss with any patients taking Cafergot about other treatment options.
- If patients are finding it difficult to find an alternative, contact your local neurologist for advice.
- Do not start new patients on Cafergot.
Products affected
The product affected is Cafergot (AFT Pharmaceuticals Ltd).
Cafergot contains ergotamine tartrate and caffeine. The current indication for use is treatment of acute attacks of migraine with or without aura in adults.
Further information
- A benefit – risk review of Cafergot under section 36 of the Medicines Act 1981 was recommended by the MARC. The review report presented to MARC is available below.
- Cafergot was approved in New Zealand in 1969. At this time the requirements for data on efficacy and safety were not as stringent as the present day. The evidence of benefit is limited and dated. In studies comparing Cafergot to sumatriptan, sumatriptan had superior efficacy.
- Cafergot may cause common adverse reactions including nausea, vomiting and ischemia. Serious vasoconstrictive symptoms or fibrosis are unusual but may develop if ergotamine is overused or taken by susceptible patients.
- The age of the Cafergot-users has increased. Cafergot is not recommended for use in patients over 65 years of age due to the increased risk of serious side effects. Cafergot has also been inappropriately prescribed outside of the approved indication to patients under 18 years of age
- There are other more modern treatment options available with superior benefit risk profiles.
Useful links
