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This article was published in November 2013. The information may be out of date. Please check our epilepsy information or our site A-Z.

MHRA: new guidance on switching meds

12 Nov 2013

New advice has been issued on whether medical professionals can safely change a person with epilepsy from one version of their medicine to another. Epilepsy medicines may now be classified in three categories depending on the supposed risk attached to switching

The new advice was released today by the Medicines and Healthcare Products Regulatory Agency (MHRA). The new guidance aims to inform the decisions of prescribers, pharmacists and people with epilepsy in relation to switching medicines.

The guidance has been released as a result of a recent review by the Commission on Human Medicines (CHM). The review explored the possible effects of a person switching from one version of their epilepsy medicine to another.

Two medication capsulesIn a previous attempt to curb the cost of paying for medicines on the British NHS, it was proposed to allow medical professionals to switch people onto cheaper generic medicines. For instance, that means that if you were prescribed Keppra, you may have then been moved to a generic levetiracetam. A ‘generic’ simply means that the drug is manufactured by a different company – but should be roughly the same.

After this proposal was made, Epilepsy Action campaigned heavily against giving medical professionals the power to switch medicines. Epilepsy Action received reports from many people with epilepsy that the switch to a generic medicine affected their seizure control and/or side effects.

The generics are similar enough to branded medicines (and to each other) that they should work in the same way. However, there are small differences in the formulation of each version. These small differences appear to affect some people with epilepsy – potentially leading to breakthrough seizures. As a result, the draft proposals were scrapped.

The National Institute for Care and Health Excellence (NICE) revised the epilepsy guidelines in 2012. At that time, it reaffirmed the guidance against switching between different versions of a medicine for people with epilepsy.

Unfortunately, the new advice issued by the MHRA may undermine this previous guidance. The MHRA statement splits epilepsy medicines into three categories as below.

Category 1

For these drugs doctors are advised to ensure that their patient is maintained on a specific manufacturer’s product.

The AEDs in this category are: phenytoin, carbamazepine, phenobarbital, primidone

Category 2

For these drugs the need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with patient and/or carer taking into account factors such as seizure frequency and treatment history

The AEDs in this category are: valproate, lamotrigine, perampanel, retigabine, rufinamide, clobazam, clonazepam, oxcarbazepine, eslicarbazepine, zonisamide, topiramate

Category 3

For these drugs it is usually unnecessary to ensure that patients are maintained on a specific manufacturer’s product unless there are specific concerns such as patient anxiety, and risk of confusion or dosing errors.

The AEDs in this category are: levetiracetam, lacosamide, tiagabine, gabapentin, pregabalin, ethosuximide, vigabatrin

Epilepsy Action is now looking into this potential change. The organisation is already aware of some people whose medication appears in category three – but who have already experienced a negative effect on seizure control after switching medicines. Epilepsy Today will continue to cover news of the change as it happens. Read the official Epilepsy Action statement here.

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