European Medicines Agency recommends restricting the use of methysergide-containing medicines
24.02.2014
The European Medicines Agency (EMA) has recommended restricting the use methysergide-containing medicines due to concerns that these medicines could cause fibrosis, a condition in which fibrous tissue accumulated 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 the side of the head, usually around the eye) when standard medicines have failed.
The EMA’s Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to 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 CHMP 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. Methysegride 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 Methysegride should therefore no longer be used in carcinoid disease.
Information to patients
- Methysergide-containing medicines may cause a potentially serious condition known as fibrosis, in which scar tissue accumulates in some of the body’s organs. As a result of this, the use of these medicines is being restricted to the prevention of severe intractable migraines and cluster headaches when standard medicines have failed.
- Methysegride should no longer be used for treating diarrhoea caused by carcinoid disease. If you are being treated for this purpose, please contact your doctor to discuss alternative treatment.
- If you are using methysergide to prevent migraines and cluster headaches, your doctor will check on a regular basis whether you are developing any signs or symptoms of fibrosis. Your doctor will stop your treatment if fibrosis is suspected.
- Your doctor will also regularly re-assess the need for you to continue treatment with methysergide by seeing if your symptoms return after periodic breaks in treatment.
- Patients who have any questions should speak to their doctor or pharmacist.
Information to healthcare professionals
- Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease.
- Following the review of methysergide-containing medicines, methysergide should now only be used for:
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- Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults, when treatment with standard medicines has failed. Previous treatment must have included treatment with medicines of other classes for at least 4 months at the maximum tolerated dose;
- Prophylactic treatment of episodic and chronic cluster headache in adults when treatment with standard medicines has failed. Previous treatment must have included treatment with medicines of at least 2 classes for a minimum of two months.
- Treatment with methysergide should only be started and supervised by specialised physicians with experience in treating migraine and cluster headaches.
- Patients should be screened for fibrosis at baseline and at least every 6 months thereafter. Screening investigations may include heart ultrasound, abdominal MRI and lung function tests. Treatment must be stopped if a patient develops symptoms suggestive of fibrosis unless an alternative cause is confirmed.
- Treatment must not begin until after the patient has been examined for any pre-existing fibrotic conditions. Once treatment is started the patient must be examined for occurrence of fibrosis at 6-monthly intervals. This examination should include a re-assessment of the benefit-risk balance in the individual patient.
- During treatment with methysergide, a treatment-free period of at least 4 weeks must be allowed between treatment courses at least every 6 months.
In the Republic of Croatia there is no approved methysegride-containing medicine.
