Sodium Valproate: an anti-epileptic drug that has caused patient harm for 50+ years

This story demonstrates how the pharmaceutical industry makes huge profits from drugs that seriously harm patients, and how it uses it's allies, in government, conventional medicine, and the mainstream media, to make sure no-one realises that the drugs they are taking are harmful.

Sodium Valproate is an epilepsy drug, an anti-spasmodic. It was first approved in 1967, over 55 years ago. Conventional medicine has known it causes patient harm for most of that time; but despite restrictions of prescribing it, it is still being prescribed, and will continue to be so. Despite the fact that it is still causing serious harm.

Anyone who knows the history of pharmaceutical medicine should not be surprised to hear this. It has happened, and it continues to happen, with most prescribed drugs. Go to this link for other drugs that have gone through a similar process. Patients taking any of these drugs do not usually its history of harm, at least, not the full extent of the damage they can cause. Conventional medicine insists that they are "safe and effective" - for as long as they can.

I wrote about Sodium Valproate 13 years ago, here, "Epilim; a dangerous drug, but no legal redress for families". 

In January 2024 NICE (the UK's National Institute for Health and Care Excellence) introduced new restrictions.

        "From January 2024, valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is not other effective or tolerated treatment, or unless there are compelling reasons that the reproductive risks do not apply".

Powerful advice indeed! But should not this advice have been given over 55 years ago?

Conventional drug-based medicine might appear to be protecting patients against dangerous drugs like Sodium Valproate, but they have not been doing so, so stringently, for the last 55 years. What this means is that the drug has been harming patients throughout this time, that drug companies have been profiting from selling it; and they can still do so as the drug continues to be available for prescription!

Except, of course, that conventional medicine has known (or should have known) about how dangerous this drug was for a very long time.

• My 2010 blog on Sodium Valproate (Epilim) concerned a group of parents whose children had been harmed by this drug who were seeking legal redress. They were opposed by the drug company, the NHS, and the government - who presumably maintained that the drug was "safe and effective".

So a drug like Sodium Valproate can be (i) tested by medical science and pronounced "safe and effective"; (ii) national drug regulators (whose sole task is to protect patients from dangerous pharmaceutical drugs) can examine and approve it; (iii) the drug company can sell it to medical authorities; and (iv) doctors can prescribe it to patients. And vast profits can be made, especially when the drug is protected by the conventional medical establishment, including both government and the mainstream media. 

In 2020 the Independent Medicines and Medical Devices Safety Review’s (IMMDSR) report, ‘First do no harm’, picked out Sodium Valproate as a particularly dangerous drug. It explored the harm it caused. There is actually a disease named after the drug - foetal valproate spectrum disorder (FVSD), which is the blanket diagnosis for the wide variety of disorders and development issues known to be caused when the foetus is exposed to the drug in the womb​​. The babies are born with birth defects that include spina bifida, autism, malformations of the brain, heart, and kidneys, and in severe cases, death.

A Patient Safety Commissioner, Henrietta Hughes, described the ongoing use of Sodium Valproate as  “a far bigger scandal than thalidomide”.

​The IMMDSR report made headline news, unusual for such negative news about pharmaceutical drugs. Even the mainstream media could not ignore it at the time. But eventually the publicity was effectively ignored. The fact that conventional medicine can continue to use the drug is testimony to this. Once, harmful pharmaceutical drugs were banned by drug regulators. This is what should happen but it appears that this is no longer the case - regardless of the horrendous publicity. There has been much more, as these few examples demonstrate.

• In January 2018 this BBC News video talked about "the sodium valproate scandal", exposing "the scandal of sodium valproate and pregnancy, and how devastatingly it could affect family for generations".

• In April 2022 the MHRA (UK's drug regulator) looked into cases of unsafe epilepsy drug being given to pregnant women as it was "associated with birth defects", and without proper warnings being given to patients.
  

•  In December 2022 the MHRA recommended that no one should take the drug "without advice from their healthcare professional".
  

• In February 2023 BBC News reported that a woman, who three children were born with disabilities after she was prescribed an epilepsy drug during pregnancy has "welcomed new GP guidance". (Note, after 55 years during which time the damage had been done, but the guidance was "new"). This article comments, sagely, that "it is thought thousands of UK children have been harmed by foetal exposure to sodium valproate since the 1970's".

One of the findings of the IMMDSR report was that the voice of the patient has been dismissed over the years, that conventional medicine (the NHS) just did not listen to them. Remember my 2010 blog? The large group of parents, with damaged children, who went to court to argue that what they were being told (that the drug was "safe and effective") was not correct? They lost! And as a result of this, so did many more parents whose children were born, damaged, during the next 12 years. 

So perhaps the new guidelines will protect potential parents now - if doctors follow the guidelines. But no-one should believe that Sodium Valproate's only adverse drug reaction is to cause serious birth defects. It is now thought that male infertility can be damaged. The drug is also known to cause of other serious conditions, such as nausea, confusion, delusions, feeling of unreality, mental depression, difficult/laboured breathing, vomiting, weakness, bleeding, encephalopathy, suicidal thoughts behaviour, and many more. It's all in official medical literature! To see a more complete list of adverse reactions visit this link. 

Except, of course, that for an entirely complete list of adverse drug reactions to Sodium Valproate we might have to wait another 55 years! The pharmaceutical industry is a slow learner, especially when big drug profits are being made.

Nor should anyone believe that Sodium Valproate is prescribed only for epilepsy. It is also used for people with Bipolar Disease, and Schizophrenia, Migraine - and several other illnesses.

And many people will not know that they are taking Sodium Valporate, as like most pharmaceutical drugs, it is branded under many different names. These include Absenor, Convulex, Depakene, Depakin, Depakine, Depakine, Depalept, Deprakine, Encorate, Epival, Epilim, Stavzor, Valcote, Valpakine, Orfiril, and no doubt many others. The branding of drugs seems to be done to deflect attention, and create confusion! One drug, with a multiplicity of names!

The conclusion is easy to relate. Sodium valproate has been associated with birth defects for many years. The medical profession has denied this for 55 years, during which time thousands of patients, around the world, have been damaged. Patients were not properly informed about the dangers - not least because the medical profession were denying these dangers until recently. Conventional medicine invariably does so, and many of the drugs they say are "safe and effective" today are nothing of the sort. But we will not know, or be told, for many years, if not decades.

 

The fact is that most pharmaceutical drugs are harmful to patients; the medical establishment is quite aware of the harm they cause (it is in the medical literature) but it continue to allow doctors to prescribe them. Moreover, patients continue to take them because they are not adequately informed about their dangers.