Epilepsy Action expresses concern over new guidance on epilepsy medication

12 November, 2013

National charity Epilepsy Action has expressed major concerns over new guidance on prescribing epilepsy medicines. The new guidance has been released today by the Medicines and Healthcare Products Regulatory Agency (MHRA). It means that epilepsy medicines will now be classified in three categories depending on the supposed risk attached to switching between different versions of the same medication. Epilepsy Action is calling for one of these categories to be suspended pending wider consultation on its implications.

Evidence suggests that switching between branded and generic versions of epilepsy medicines can cause problems for patients. These include loss of seizure control and adverse side effects. Loss of seizure control is a major issue for many people with epilepsy, affecting employment, education and social life. For example, a single seizure can cause the loss of a driving license for a year, and this may impact on a person’s quality of life.

Simon Wigglesworth, deputy chief executive at Epilepsy Action, said: “We are surprised and disappointed that this decision has been taken without wider consultation. We have major concerns about the introduction of category 3 of this guidance. We would ask that the MHRA suspend this category, pending wider consultation on the evidence that its introduction is based on.

“Category 3 gives the green light for some drugs to be switched without input or discussion from patients. We know that clinical evidence has shown that switching between the branded and generic versions of levetiracetam (Keppra) – one of the category 3 drugs - can have an adverse effect on patients. Under these new regulations, levetiracetam could be automatically switched without any discussion with the patient.

“Also, some drugs listed in category 3 currently have no generic version. As such, there is no evidence that switching between preparations of these drugs is safe. It is a concern that these drugs will remain in category 3 by default when a new generic is released.

“We support the development of category 1 as there is substantial evidence to suggest that drugs listed in this category should not be switched. Category 2 is in accordance with NICE clinical guidance and is current practice.

“We want to see category 3 suspended and would ask that the MHRA makes available the full report or review of the evidence, and a list of the evidence used, as a priority. Understanding how this decision has been reached is crucial in wide-range acceptance of the new advice among people with epilepsy, their carers and their doctors. Patients must be reassured that decisions are based on sound evidence and will not adversely affect care or seizure frequency.”

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  • When they tried to do this before it was voted against after a public outcry the NHS are doing this in a sly and underhand way this time and we need to contact the MPs and NHS committees to express how we are disgusted with this again

  • We was taken by surprise and disappointed that this decision has been taken. We are campaigning against this decision. Please do talk to your MP and local NHS services.

  • Different brands of a drug have different side effects and the can also cause a person problems in other ways. As stated loss of control of a persons seizures can result in some serious consequence's such as loss of driving licence or loss of a job. I can speak from experience as I have had problems when I was given a generic version of trileptal and it caused some very painful side effects. I understand the government / NHS wish to save money and I would not have a problem taking a cheaper version of a drug but the problem with this is consistency if NHS are giving the cheapest version of a drug out you could end up taking a different version each month as it becomes a bidding war. A persons body gets use to a drug over a period of time and as such the side effects are lessoned and the way a persons system takes the drug become normal this is not acceptable and I have brought it up with my MP again and she contacted the secretary for Health who denied it was practice / instruction I showed it was happening and she brought it up in parliament I don't know if you seen the speach

  • Thank you for continuing to campaign with your MP about this issue. We are still collecting the details of people who have had issues with generics and the prescribing of their epilepsy medicines. If you are willing, our campaigns department would love to hear from you. They can be reached by email at campaigns@epilepsy.org.uk.

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