Methysergide-containing medicines
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
Restrictions on the use of methysergide-containing medicines
On 20 February 2014, the European Medicines Agency recommended restricting the use of methysergide due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body's organs potentially damaging them. Methysergide medicines are now only to be used for preventing severe intractable migraines and cluster headaches (a type of severe, recurring headache on one side of the head, usually around the eye) when standard medicines have failed.
In addition, treatment should only be started and supervised by a specialist doctor with experience in treating migraine and cluster headaches. Patients should also be screened for fibrosis at the start of treatment and should have additional screenings every 6 months. Treatment must be discontinued if symptoms of fibrosis occur.
The Agency's Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to the reports of fibrosis seen with methysergide and other medicines of the same class (ergot derivatives). The symptoms of fibrosis often take some time to appear and without screening the diagnosis may come too late to prevent severe (and potentially life-threatening) damage to organs .
Regarding the benefits, the Committee noted that there is some evidence of a clinically relevant effect of methysergide when used for prevention in patients who regularly get migraines and cluster headaches and for whom treatment options are limited. Methysergide has also been used for treating diarrhoea caused by carcinoid disease (a slow-growing tumour that commonly affects the gut). However, there were no data to support this use and Methysergide should therefore no longer be used in carcinoid disease.
The prescribing information for physicians and information in the patients' information leaflet has been updated. The CHMP recommendations were sent to the European Commission, which has endorsed them and issued a final legally-binding decision that is valid throughout the EU.
Key facts
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About this medicine
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|---|---|
| Approved name |
Methysergide-containing medicines
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| International non-proprietary name (INN) or common name |
methysergide
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| Associated names |
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| Class |
Ergot alkaloids
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-31/1335
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| Type | |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
20/02/2014
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| EC decision date |
28/04/2014
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
Methysergide Article-31 referral - European Medicines Agency recommends restricting the use of methysergide-containing medicines (PDF/77.49 KB)
First published: 21/02/2014
Last updated: 21/02/2014
EMA/798712/2013
Methysergide Article-31 referral - Annex III (PDF/95.73 KB)
First published: 21/02/2014
Last updated: 27/05/2014
European Commission final decision
Methysergide Article-31 referral - Assessment report (PDF/302.01 KB)
First published: 27/05/2014
Last updated: 27/05/2014
EMA/276466/2014
Methysergide Article-31 referral - Annex I (PDF/45.9 KB)
First published: 27/05/2014
Last updated: 27/05/2014
Methysergide Article-31 referral - Annex II (PDF/97.06 KB)
First published: 27/05/2014
Last updated: 27/05/2014
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.