Methysergide: serious fibrotic reactions
- Medicines and Healthcare products Regulatory Agency
- 12 March 2014
- Therapeutic area:
Restricted use and new monitoring requirements.
Article date: March 2014
Methysergide (Deseril) should only be used for the prophylactic treatment of severe intractable migraine and episodic and chronic cluster headache in adults when treatment with standard medicines has failed. Treatment should be initiated and supervised by specialists.
A Europe-wide review concluded that there is a risk of fibrosis (mainly retroperitoneal fibrosis) associated with methysergide treatment. This side effect may be serious and in some cases irreversible or fatal. Healthcare professionals should note the following advice to help minimise the risks:
Advice for healthcare professionals:
- Methysergide should only be used for prophylaxis 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 medicines of other classes for at least 4 months at the maximum tolerated dose
- episodic and chronic cluster headache in adults when treatment with standard medicines has failed. Previous treatment must have included medicines of at least two classes for at least 2 months each
- Methysergide should no longer be used to treat diarrhoea caused by carcinoid disease
- Methysergide should only be started and supervised by specialised physicians with experience in the treatment of migraine and cluster headache
- People should be screened for fibrosis at the start of treatment and at least every 6 months thereafter. Screening must include heart ultrasonography, abdominal MRI, and pulmonary function tests. Treatment must be discontinued if symptoms suggesting fibrosis occur unless an alternative cause is confirmed
- The continued need for methysergide treatment must be reassessed every 6 months using a treatment-free interval of at least 4 weeks between treatment courses
Availability in the UK
Although methysergide is authorised in the UK, this product was discontinued in April 2013 due to manufacturing problems. It is not clear when or if this product will return to the UK market.
We are aware of imports of unlicensed methysergide for a specific patient’s needs. It is important to be aware that the product information supplied with these unlicensed products may not include all the relevant warnings (see Drug Safety Update article, April 2009). People who use unlicensed methysergide should be monitored as outlined above to minimise the risk of side effects.
European Medicines Agency statement, 21 February 2014
Published: 12 March 2014
Therapeutic area: Neurology