April 2006
As a member-led organisation, Epilepsy Action represents the interests of thousands of people in the UK, including two of the groups who would be affected by the proposal to fortify flour with folic acid: women with epilepsy of child bearing age; and people with epilepsy taking some types of anti-epileptic medication.
The British National Formulary states that ‘folates possibly reduce plasma concentration of phenytoin, primidone and phenobarbital’.
It is the opinion of our clinical advisor Dr Morgan Feely, clinical pharmacologist at Leeds General Infirmary that it is difficult to judge the effects of folic acid on anti-epileptic drugs such as phenytoin, primidone and phenobarbital. However, it is conceivable that folic acid could lower the level of these drugs, particularly phenytoin. Changes to drug levels could in turn affect seizure control.
We also recognise that flour fortified with folic acid could be beneficial for women with epilepsy of child bearing age.
Because the addition of folic acid to flour could be advantageous to a particular group of people with epilepsy, but could be disadvantageous to another group of people with epilepsy, Epilepsy Action does not feel able to take a stand for or against the fortification of flour with folic acid.
Epilepsy Action does believe that it is important that the likely effects of the fortification of flour with folic acid on both groups of people mentioned above are considered and also that opinion from medical experts in the field is sought before any regulatory decisions are made.
Epilepsy Action will participate appropriately in all relevant consultations.
The future
Should it be decided that fortification of flour with folic acid should be introduced, Epilepsy Action has already advised that the following areas should be addressed:
- People with epilepsy taking phenytoin, primidone or phenobarbital should be made aware of the possibility of the impact of folic acid on their seizure control and be advised to seek advice from their epilepsy specialist if they have any concerns.
- Women with epilepsy on all anti-epileptic drugs considering starting a family should be made aware that the clinical guidelines from NICE recommend 5mg of folic acid per day and that the level of folic acid in flour is likely to be much less than this. Women with epilepsy should be advised not to assume that the fortification of flour with folic acid would give them the necessary level of protection recommended.
- GPs should be briefed about the potential interactions between flour fortified with folic acid for people taking phenytoin, primidone and phenobarbital, and about the issues affecting women with epilepsy planning a family.
- Information about possible interactions will need to be included in the Patient Information leaflets for phenytoin, primidone and phenobarbital. The Medicines and Healthcare products Regulatory Agency and relevant drug companies should be briefed about this issue.
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