New restrictions on use of medicinal products containing ergot alkaloids
16.10.2013
The European Commission has adopted the Recommendations of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on restrictions on the use of medicinal products containing derivatives of ergot alkaloids. These restrictions refer only to dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine. These active substances may no longer be used in the following indications where the risks outweigh the benefits: symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer’s disease and other dementia), ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD, stage II), ancillary treatment of Reynaud’s syndrome, ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, acute retinopathies of vascular origin, prophylaxis of migraine headache, orthostatic hypotension and symptomatic treatment of veno-lymphatic insufficiency. This conclusion is based on the review of data indicating increased risk of fibrosis (formation of excessive connective tissue that may damage organs and organism structure) and ergotism (symptoms of ergot intoxication, as cramps and obstructions in blood circulation) after the use of these medicines
Information to patients
- Medicines containing substances known as ergot derivatives may have serious adverse reactions such as fibrosis and ergotism. Consequently, these medicines may no longer be used in the EU for the treatment of several diseases including certain problems with circulation (affecting mostly the elderly), memorising and sensories or for preventing migraine, because risks outweigh the benefits when using these medicines.
- Ask for an appointment with your doctor if you are taking medicines containing the following substances: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine. Your doctor will decide whether you should change to another treatment.
- If you are unsure whether you are affected, or if you have any questions, speak with your doctor or pharmacist.
Information to doctors
- Doctors should stop prescribing medicines containing dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine, for any of the following indications:
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- Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer’s disease and other dementia);
- Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II);
- Ancillary treatment of Raynaud’s syndrome;
- Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
- Acute retinopathies of vascular origin;
- Prophylaxis of migraine headache;
- Orthostatic hypotension;
- Symptomatic treatment of veno-lymphatic insufficiency.
- Patients currently taking these medicines for any of the above indications should have their treatment reviewed at a routine (non-urgent) medical appointment.
- Some ergot derivatives are approved in some EU Member States for use in other therapeutic indications, including other circulatory disorders, treatment of dementia (including Alzheimer’s disease) and treatment of acute migraine. These indications were not included in the CHMP review; therefore these products will remain authorised and may continue to be used in those indications.
Medicines in the EU and Republic of Croatia
The indications included in the CHMP’s review will be suspended in the EU Member States for ergot derivatives above. This means that for those ergot derivatives indicated only for the aforementioned indications, their marketing authorisations will be suspended in the EU. Other indications, including other circulatory problems treatment of dementia (including Alzheimer’s disease) and treatment of acute migraine have not been included in the CHMP’s review and therefore these ergot derivatives may be used in these indications.
Ergot derivatives authorised in the Republic of Croatia do not have any indication that is being suspended by this Commission’s Decision, therefore this restriction of indications does not refer to them.
HALMED authorises the import of ergot derivatives for a very small number of patients under the legal exemption scheme on a named patient basis. HALMED will no more approve prescriptions for import of the ergot derivatives above in indications concerned by Commission’s Decision.
HALMED has not received any adverse reaction report to ergot derivatives above that would be associated with fibrosis or ergotism. HALMED will continue to monitor the safe use of these medicines and will inform the public promptly about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
