New restrictions on use of medicines containing ergot derivatives
Press release
Human
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has 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 European Union (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 opinion will now be sent to the European Commission for the adoption of a legally binding decision throughout the EU.
Information to patients
Information to healthcare professionals
The CHMP opinion follows a review of available safety and efficacy data on ergot derivatives in the above indications, including clinical studies, post-marketing data in Europe and the published literature:
More about the medicine
Ergot derivatives are substances derived from a group of fungi commonly known as ergot. Five ergot derivatives were considered in the CHMP review: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine.
Medicines containing ergot derivatives have an effect on blood circulation and they have been used for decades to treat conditions involving circulatory problems. Certain ergot derivatives have been used to treat conditions usually affecting elderly patients, such as peripheral arterial occlusive disease (PAOD, where the body's large arteries become obstructed) causing pain when walking, and Raynaud's syndrome (where the blood supply is blocked to the extremities, usually the fingers and toes), as well as eyesight disturbances due to blood circulation problems. They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches. In some EU countries, certain ergot derivatives are also authorised for other indications not covered by the CHMP review, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
In the EU, medicines containing ergot derivatives have been authorised by national procedures and have been marketed under various trade names. The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
More about the procedure
The review of ergot derivatives was initiated on 18 January 2012 at the request of France, under Article 31 of Directive 2001/83/EC. The French medicines agency asked the CHMP to carry out a assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.