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03 February 2014

Professor Ley Sander on switching epilepsy drugs

Professor Ley Sander, medical director of Epilepsy Society, said: 'We feel we cannot fully embrace the current MHRA guidance relating to branded and generic anti epileptic drugs. We are not confident of the evidence produced or the rationale behind the grouping of certain anti epileptic drugs.'

Consistency of supply

He added, 'Consistency of supply is vital, it's the key to seizure control for many people with epilepsy. If people's drugs are substituted, medication looks different which can cause anxiety and confusion and is particularly difficult for people with memory problems, often associated with epilepsy, and the elderly,'

MRHA says there is no clear evidence of risk associated with switching between some branded and generic products, but Epilepsy Society is not convinced by this evidence.

The current proposed guidance classifies anti epileptic drugs (AEDs) into three categories  which it claims will help prescribers and patients decide whether it is necessary to maintain continuity of supply of a specific manufacturer's product.

Professor Sander added, 'It is essential for anyone with epilepsy to maintain a consistent supply of the same version of their AEDs. Switching from a branded to a generic drug may affect the bioavailability of the active ingredient in the medication and cause a breakthrough seizure or side effects and could lead to confusion when drugs look different from one prescription to the next.

Breakthrough seizures

'A breakthrough seizure can have huge potential health care cost implications - accident and emergency admission and injuries related to the seizure.  It is difficult to prove the cause of a breakthrough seizure in someone who has previously managed to control their epilepsy, but these seizures can have devastating impact for the individual concerned and their family.  Driving licences must be surrendered and often employment becomes difficult.'