How safe are epilepsy drugs?

However, sometimes epilepsy medication can cause harm to the patient or even their unborn child.  This is particularly the case with Sodium Valproate, which goes by the brand names Epilim and Depakote.

Next week, women whose children have been harmed by this drug will give evidence to a European-wide safety review that will examine whether warnings about risks to unborn babies are strong enough.

All medication – not just Sodium Valproate – of course, has side-effects and risks. These must be weighed up against the benefits of medication. In order to weigh up the pros and cons, the patient and treating team must know what the risks and side-effects could be.  Worryingly, this has not always been the case with Epilim – and I can say that from personal experience when I took the drug some years ago.

Sodium Valproate/Epilim used to be a very common medication for people with epilepsy, but for many years it has been known that Epilim increases the risk of a baby born to a mother taking Epilim suffering physical abnormalities and cognitive impairments.  Babies exposed to Epilim/Sodium Valproate in the womb have a 10% chance of developing physical abnormalities and a 4 in 10 chance of developing cognitive problems, such as learning disabilities and autism.  Evidence of this risk emerged back in the 1980s, but for years many patients have not been told about the risk.  Medical advice now is that Epilim/Sodium Valproate should not be used during pregnancy unless there is no safer alternative and only after a careful discussion of the risks.

There is currently a group action in France against the drug company which makes Sodium Valproate, Sanofi.  In the past, there was also a group action in the UK.

Whilst drug companies must give comprehensive and clear advice on all side-effects and potential risks, the responsibility to inform a patient and weigh up the pros and cons does not fall solely to the drug company.  A patient’s treating doctor must advise the patient about the side-effects and risks.  The doctor might have been negligent if she fails to do so.

Doctors are under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment and of any reasonable alternative or variant treatments.  A significant risk is one which would affect the judgment of a reasonable patient.  Surely a 10% risk of a baby developing physical abnormalities and a 25% risk of cognitive problems is a significant risk that doctors should make all patients aware of so that they can make their own decision about their life and that of future children.

Ann Houghton is an associate in our clinical negligence team and is responding to an article on the BBC website today.

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