Sodium Valproate is a common and effective anti-epileptic drug, frequently prescribed in the UK. It is also known as Epilim, Episenta and Epival.
However, when prescribed to a pregnant woman, it can cause devastating injuries to her child. The drug carries a 10% risk of causing serious physical abnormalities and a 40% risk of developmental problems. The drug is believed to cause damage to the fetus in the first days after conception, so switching to a different drug after the pregnancy is discovered is not a helpful option.
This risk has been known for many years with the first animal studies being published in the 1980s, and, while prescribing guidance has stated that very clear warnings should be given, that it should only be used where other safer drugs have been tried unsuccessfully, it seems clear that this information has not been reaching patients.
A survey by a group of UK epilepsy charities has found that one in six women taking sodium valproate did not know of the risks it posed to unborn babies. More than one in five had had no discussion with a healthcare professional about its risks. 68% had received no printed material from the government’s information “toolkit”, which was issued in February 2016 and which should have been given to all women on sodium valproate.
The law regarding what information patients should be given, regarding the risks of proposed medicines and medical treatment, has changed over the last few years. Patients must be given “all material information” regarding the safety or risk of the treatment, including a discussion of all the available alternatives. If a doctor fails to provide such information to a patient, they would be regarded as having been negligent and would be legally responsible for the consequences of that negligence.
If you have been prescribed sodium valproate without clear warnings of its risks, and if your child has been injured as a result, you might be able to bring a medical negligence claim against the healthcare professional who prescribed the drug to you.