Sodium Valproate Scandal – Epilepsy Drug Risks Known For 40 Years


The Law Of… Informing Patients About Risks

A controversial epilepsy drug, which has been said to have harmed more children than Thalidomide, is once again back in the headlines. Geoffrey Simpson-Scott, a Medical Negligence Partner at Simpson Millar, reports on the latest fallout surrounding sodium valproate.

The Risks Of Sodium Valproate

The continuing controversy dogging the epilepsy drug, sodium valproate, has been reignited by the revelation that problems associated with it could have been made public over 40 years ago.

Marketed under brand names such as Epilim and Convulex, sodium valproate is an anticonvulsant that is given to sufferers of epilepsy and, in the vast majority of cases, has no adverse effects. The risks arise if the recipient is pregnant.

The medication, taken to prevent seizures, is linked to birth injuries in infants. It is said that babies exposed to the epilepsy drug while in the womb have an 11% chance of being born with defects and a 40% chance of further problems with development.

Issues have arisen with regards to informed consent, where women prescribed sodium valproate have not been told of the risks to their baby should they fall pregnant. This has led to campaigners calling for greater awareness.

The Dangers Were Suppressed

The news that the dangers associated with the drug were known as far back as 1974 was revealed by the Fetal Anti Convulsant Syndrome (FACS) Association. At the time, the Committee on Safety of Medicines (CSM) – later replaced by the Commission on Human Medicines – decided not to share these concerns as "it could give rise to fruitless anxiety". It continued that a warning should not be added to packaging, "So there would be no danger of patients […] seeing it".

The announcement was made at a public hearing held as part of a European Medicines Agency (EMA) risk assessment of sodium valproate. The FACS Association has long campaigned for tighter controls on the epilepsy drug, including a blanket ban for all women of childbearing age.

The EMA set up the risk assessment to decide whether extra safeguards should be put in place to protect young women, with figures estimating that as many as 20,000 UK children could have been affected as a result of the drug.

Still Unaware Of The Risks

Contrary to the call for an outright ban, doctors have stressed that in some cases sodium valproate is the only suitable drug to keep seizures under control. Even so, and despite the introduction of a 'toolkit' to raise awareness of its dangers, a survey on behalf of the Epilepsy Society found that 18% of young women who took part were still unaware of the pregnancy risks surrounding the drug.

What If My Child Is Affected?

If you have been prescribed sodium valproate (Epilim, Convulex, Episenta, Epival) and are worried about the risk to your unborn baby, you should speak with your GP.

If your baby was born with a birth injury after taking the epilepsy drug, it is again advised that you speak to your GP first. If you are dissatisfied with the outcome and believe your child's injuries were avoidable, you should seek expert and independent legal advice.

Geoffrey comments:

"The FACS Association's campaign raises legitimate concerns about what was known by regulators and doctors about the safety of this epilepsy drug. These should be answered quickly as patient safety is of paramount importance."

"Issuing clear guidance now will allay fears and save health professional's time, while reducing costs for the NHS."

If you underwent a treatment without being fully informed of the risks involved, resulting in injury to you or your baby, you may be entitled to compensation. Contact Simpson Millar to discuss your case today.

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