Epilepsy charity urges rethink on drugs-switching
Clinical Epilepsy Action calls for medicines watchdog to suspend its advice that certain drugs are safe to switch between
An epilepsy charity has urged the MHRA to rethink its guidance on anti-epileptic drugs, voicing "major concerns" over allowing branded to generic switches for certain patients.
Epilepsy Action said it was "surprised and disappointed" that the MHRA had failed to consult more widely before publishing its new advice, which suggested that not all anti-epileptic drugs were dangerous to switch.
The guidance, published on Tuesday (November 12), split anti-epileptic drugs into three categories depending on the level of risk. Category one drugs were deemed to be the most risky to switch, with clinicians advised to avoid doing so at all, while the MHRA said it was "usually unnecessary" to stick to a particular manufacturer of category three drugs (see below for details of the three categories).
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The MHRA split anti-epileptic drugs into three categories depending on the level of risk to patients |
 More on the MHRA
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The MHRA told C+D it had devised the categories after fully reviewing the available evidence and giving "due consideration to the concerns of patients and prescribers". |
MHRA urges caution in switching epilepsy drugs|
But Epilepsy Action expressed "major concerns" over category three, which includes seven drugs such as gabapentin and levetiracetam, and called for the medicines watchdog to suspend the category pending a wider consultation on available evidence. "We know that clinical evidence has shown that switching between the branded and generic versions of levetiracetam can have an adverse effect on patients," said Simon Wigglesworth, deputy chief executive of the charity, in a statement released on Wednesday (November 13) He highlighted that some drugs in category three had no generic version. "As such, there is no evidence that switching between preparations of these drugs is safe," he argued. "It is a concern that these drugs will remain in category three by default when a new generic is released." He called on the MHRA to make the full evidence for its decision available "as a priority" to assure patients that switching would not adversely affect their care or seizure frequency. C+D readers also expressed reservations over the guidance, arguing that supply problems could prove a stumbling block. One reader said on C+D's interactive stock shortages tool that they were unable to source Lamotrigine – a category two drug – for a patient. The prescription had to be substituted with Lamictal, which caused the patient to end up in hospital. |
The three categoriesCategory one medicines: Phenytoin Carbamazepine Phenobarbital Primidone Category two medicines: Valproate Lamotrigine Perampanel Retigabine Rufinamide Clobazam Clonazepam Oxcarbazepine Eslicarbazepine Zonisamide Topiramate Category three medicines: Levetiracetam Lacosamide Tiagabine Gabapentin Pregabalin Ethosuximide Vigabatrin |
Readers' comments were echoed by Calum Nelson, a locum pharmacist commenting on the C+D website. "Half the time we can't get the drug from any manufacturer and, with generic suppliers, there usually isn't any system in place to order a specific make," he said.
The MHRA told C+D that it would welcome any evidence that Epilepsy Action had to support its concerns. "This new advice was developed following a full review of the available evidence and with consideration of the characteristics of the different AEDs in relation to therapeutic index, solubility and absorption," a spokesperson said.
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