Ergot derivatives

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


Restrictions on use of medicines containing ergot derivatives

On 27 June 2013, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of medicines containing ergot derivatives. These medicines should no longer be used to treat several conditions involving blood circulation problems or problems with memory and sensation, or to prevent migraine headaches, since the risks are greater than the benefits in these indications. This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.

Ergot derivatives that are only indicated for these conditions will have their marketing authorisations suspended across the EU. In some EU Member States, ergot derivatives are also authorised for other indications such as treatment of dementia, including Alzheimer's disease, and treatment (as opposed to prevention) of acute migraine headache. They will remain authorised for use by patients in those indications.

In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature. The review was initiated due to concerns identified by the French National Agency for the Safety of Medicine and Health Products (ANSM) in a national pharmacovigilance review in 2011.

Fibrosis can be a serious, sometimes fatal disease, which is often difficult to diagnose because of delayed symptoms and may be irreversible. The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism. Given that the evidence for these medicines' benefits in these indications was very limited, the CHMP concluded that the benefits in the concerned indications did not outweigh the risk of fibrosis and ergotism.

The CHMP recommendations were sent to the European Commission, which has endorsed them and issued final legally binding decisions that are valid throughout the EU.

Key facts

About this medicine
Approved name
Ergot derivatives
International non-proprietary name (INN) or common name
  • dihydroergocristine
  • dihydroergotamine
  • dihydroergotoxine
  • nicergoline
  • dihydroergocryptine
  • caffeine
Ergot derivatives
About this procedure
Reference number
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

European Commission final decision
Key dates and outcomes
CHMP opinion date
EC decision date

All documents

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

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