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.

Epilim; a dangerous drug, but no legal redress for families

Dozens of families who blame an epilepsy drug, Epilim, for causing birth defects in their children (see information on FACs) say they are devastated that legal aid to sue its maker has been withdrawn. So says a BBC report at:

http://www.bbc.co.uk/news/uk-11707386

What is important in this story is not just that no patient is safe taking ConMed drugs, but that drug companies don't admit that their drugs have done anything 'wrong', and, in the UK, the government does not enable families to take such matters to the courts. There is little justice.

So it would seem that UK patients have to be even more careful than those in the USA. In the USA, 'class actions' against drug companies are regularly passing through the legal system, so at least those who have suffered disease and death have some access to justice, and drug companies have been forced to pay many $billions in compensation for the suffering and distress they cause.

The families concerned have children that have suffered because Epilin by the mother during pregnancy. This has caused their children to be born with spina bifida, heart damage and learning difficulties. Their lives have been devastated by ConMed drugs.

And it would appear that in the UK the drug companies, the government, and the NHS are not prepared to take any responsibility.

FACs. Fetal Anti-Convulsant Syndrome. A disease created by Big Pharma drugs?

Some years ago, I came across a family with two children suffering from this syndrome. This 'new' illness has affected 37,500 children in Britain, according to the British Epilepsy Association. FACS produces a range of neural, behavioural, and physical disorders, and can include conditions such as cleft palate and spina bifida, learning difficulties, behavioural problems and abnormalities in movement, speech, vision and hearing.

So what is FACS, and where does it come from? 

Yet another new, strange and rare disease with no known cause? Well, not really, the cause is well known. 

These children were damaged in the womb when the mother had taken anti-convulsant drugs, such as Epilim and Carbamazepine.

So FACS is, in fact, another conventional medical 'mistake', another disaster for parents and families where the 'science' of drug testing and drug regulation has proven to be no safeguard to public safety. At the time of writing, this condition has had little publicity, but this, in itself, is something that should be a matter of public concern. 

1. *Why are we not being told about such disease? 
2. *What is preventing this information becoming more widely known?

Janet Williams, who has two sons affected by FACS, founded the Organisation for Anti-Convulsant Syndrome (OACS). She says:

          "We want to hear from any family with a child with problems whose mother took any anti-epileptic drug in pregnancy".

She goes on to say that many of these children have been diagnosed with autism spectrum disorders (ASD). What do the drug companies say about it? Well, the usual denials.

* Anti-epileptic drugs are vital to the health of people with epilepsy, who should not stop taking them without consulting their doctor (so it is a balancing act again, weighing up the 'benefits' and the 'risks' of taking drugs).

* Health authorities regularly routinely and continually review the safety of all licensed medications (including, presumably, these drugs, so no comfort for the children or their parents who suffer from FACS).

* That warnings were given about valproate (the basic ingredient of epileptic drugs) in respect of possible effects in children born to mothers taking the product during pregnancy, and that "this information was approved by the regulatory authorities as consistent with current scientific knowledge" (which suggests that the dangers of the drugs were known to medical authorities, but they were prescribed to patients anyway).

This is just one example of how the Conventional Medical Establishment, with their drug-based medicine, are actually creating illness.

EPILEPSY. Another drug is banned - after being 'widely prescribed' for over 50 years.

Conventional medicine does not protect patients from the harm caused by its pharmaceutical drugs and vaccines.

Valporoate has just been banned by the UK's drug regulator, the MHRA (April 2018). Doctors have been instructed not to prescribe this epilepsy drug to any women of childbearing age, "unless they are on a pregnancy prevention programme". Doctors have also 'advised' not to prescribe the drug, also known as Epilim, or Episenta, or Depakote, for the treatment of migraine and bipolar disorder. So is this evidence that conventional medicine is protecting patients?

Hardly. The drug was discovered in 1882, and its 'anticonvulsant properties' in 1962. The pharmaceutical industry quickly obtained approval from French drug regulators in 1967 and Valproate quickly became the most widely prescribed epilepsy drug throughout the world.

So it has taken conventional medicine over 50 years to discover that Vaproate was a dangerous drug, and to take action to protect patients.

This tardiness is not untypical of conventional medicine, and their failure to protect patients. I have listed many pharmaceutical drugs and vaccines that have been banned or withdrawn over the last 100 years and more. The same process is repeated, time and time again. A drug is found, it is quickly approved by drug regulators (whose main task is not to approve drugs but to protect patients from harm), used thereafter for many years, often many decades, and only accepted as 'dangerous' when this can no longer be denied. So is it possible that the conventional medical establishment did not realise that valproate was dangerous.

Hardly. The (appropriately entitled) health magazine, What Doctor's Don't Tell You (WDDTY) reported as long ago as April 2005 that pregnant women taking Valproate for their epilepsy were doubling the risk of their unborn child developing cognitive impairments.

Since then the evidence against Valproate has been building, but largely censored by the mainstream media (who have still, at the time of writing, to my knowledge, not reported the ban), and ignored by conventional medicine. So our doctors have continued to prescribe it regardless of the harm it has caused to patients. 

Doctors have been warned about the drug throughout the last 50 years - consistently. For example, on 13th October 2014 the GP magazine, Pulse, published an article "GP's advised not to prescribe valproate medicine to pregnant women". 

• There is little doubt that this dangerous drug has continued to be prescribed despite its dangers being well known within the conventional medical establishment.
• Nor can there be any doubt that over 50 years, many pregnant women have taken this drug, on the advice of their doctor, and many are now caring for children who were damaged by the drug.

So is it just pregnant women who are in danger from this drug? Hardly. Have a look at the Drugs.com website (now apparently owned by the pharmaceutical industry). They have posted these warnings about Valproate.

• This medicine may cause very bad and sometimes deadly liver problems. This most often happens within the first 6 months of using valproate injection...... 
• Children under 2 years are at greater risk of deadly liver problems.....
• There is a greater risk of liver failure and death in patients who have a genetic liver problem caused by a mitochondrial disorder.....
• This medicine may cause very bad birth defects if you take it while you are pregnant. It can also cause the child to have a lower IQ....
• If you are able to get pregnant, you must use birth control that you can trust while you take valproate injection......
• This medicine may cause very bad and sometimes deadly pancreas problems (pancreatitis). This may happen soon after use as well as many years after use.....

Then click on the linked 'side effects' page to see the full horror story of Valproate, and remember that this is a drug that conventional medicine has been quite happy to use for the last 50 years, and only now, only in the UK, has it been banned. This happens so frequently that no-one should consider any pharmaceutical drug or vaccine to be safe, regardless of what their doctors say.

If anyone, at this moment, is taking a pharmaceutical drug, be warned. The conventional medical establishment is not there for our safety, it is there to sell drugs - quite regardless of the harm they may cause us. The drug(s) YOU are taking, at THIS moment, may be the next drug that has to be banned!

Sodium Valproate. The demise of another pharmaceutical drug. 20,000 damaged children? A tragedy worse than Thalidomide?

Pharmaceutical drugs are known to be dangerous. Sometimes even doctors are forced to admit this. There are even times when even the mighty Conventional Medical Establishment can no longer defend the harm their drugs and vaccines do to patients. For the antiepileptic drug, sodium valpoate, this  time appears to be rapidly happening.

Please Note: sodium valproate comes to patients under many different names - rarely sodium valproate. It is vaariously called Absenor, Convulex, Depakene, Depakine, Depalept, Deprakine, Dyzantil, Encorate, Epilim, Epivil, Episenta, Stavzor, Valcote, Valpakine, Orgiril, and no doubt many more (just to confuse us patients! What on earth do these names mean? Why do pharmaceutical companies need so many?)

On Sunday 17th April 2022, the Sunday Times headline blew a whistle (a whistle they use so rarely) on this drug (I will ask "Why?" later). Its front page headline stated "Drug Scandal that damaged 20,000 babies: epilepsy pills are still being given to pregnant women in a travesty that recalls thalidomide". Its editorial announced that "20,000 babies damaged - and still the scandal continues". The main article began:

            " Health experts knew in 1973 that the epilepsy medication sodium valproate posed a risk to unborn children - but mothers-to-be were not told. Almost 50 years and 20,000 disabled children later, it is still being prescribed to pregnant women. Now some are saying 'this scandal is worse than Thalidomide".

Worse than Thalidomide? I have written about the Thalidomide scandal before, briefly outlining the events on this link. It was a tragedy that led to the introduction of our current system of pharmaceutical drug regulation, now used around the world, and intended to ensure that such event would "never happen again". Clearly it has failed. Moreover, as this story shows, the new system of regulation was already failing at the very time it was being set up!

And the problem is almost certainly bigger than the Sunday Times says. If it is thought that 20,000 babies have been damaged that number could be multiplied by 10, even perhaps 100 times, given that regulatory reporting systems are notoriously bad at picking up cases. And, as the Sunday Times outlines, the harm caused by sodium valproate has been going on now for nearly 50 years now - and yet the drug is still being prescribed by doctors, and little of no action has been taken to protect patients from it.

WHAT THE SUNDAY TIMES ARTICLE TELLS US

Very few people read the Sunday Times. Its articles are not openly available on the internet, and few people now buy newspapers. So here are some quotations from the article.

        "Sodium valproate, which was given to women with epilepsy for decades without proper warning, has caused autism, learning difficulties, and physical deformities in up to 20,000 babies in Britain".

        "... despite... a 2020 report that criticised the failure over four decades to tell women of the dangers, doctors are still not properly warning women of the risks......."

        "An investigation by the Sunday Times has found that the drug is being handed out to women in plain packets with the information leaflets missing, or with stickers over the warning". (My emphasis).

The article tells us that the problem of birth defects caused by the drug was discussed as early as 1972 and 1973, when "the manufacturers, Sanofi, told the committee that there were signs in animal tests that valproate could potentially be teratogenic - harmful to foetuses" but the committee "concluded that the use of anti-seizure drugs ... was indeed liable to produce abnormalities" but that "the risk appears to be low, and not sufficient to justify stopping the use" of the drug.

        "They specified that warnings should be provided to doctors, but not on package inserts, so that there would be no danger of patients themselves seeing it". (My emphasis).

The Sunday Times article goes on to outline the subsequent history of the harm caused by the drug over the last 50 years, and the regular warnings that have arisen over time. These range from reports in the Journal of Paediatrics in 1980, the British Medical journal in 1983, debates in the House of Commons, reviews in the Lancet, et al.  

Each time, little or nothing was done to warn or protect patients - indeed the opposite.

            "The CSM (Committee on the Safety of Medicine) finally acted on the concerns, asking Sanofi to write to all GPs and hospital doctors with a new warning sheet, setting out the sodium valproate could lead to birth defects. However, the committee still stopped short of requiring doctors to tell women about the risks, with the danger of spina bifida not being including on patient safety leaflets until 1994. And still no detailed research into the effects of the drug was commissioned".

Warning after warning followed. A study in 2009 confirmed that the use of the drug in pregnancy could damage children's IQ. Yet it was only in 2010 that patient information sheets referred to the risk to cognitive development, including autism.  

So it is quite impossible that the dangers of Sodium valproate could have remained unknown to any doctor, or anyone connected with the conventional medical establishment. 

But nothing has ever been done, pregnants women are still being prescribed the drug. The thalidomide scandal was supposed to lead to new drug regulation procedures whose primary objective was to protect patients. Yet no action was taken to protect patients from sodium valproate at the time, and for the next 50 years! Drug regulation does not work to protect patients. The system has been taken over, consumed by the drug companies it is supposed to be regulating.

After many years, during which time government, the conventional medical establishment, the NHS, and doctors did not act, patients tried to take action themselves. A lawsuit was brought up against Sanofi; but this collapsed before the trial when legal aid was withdrawn. The government has a vested interest in not wanting such a trial to go forward, so they took action that ensured that patients could not obtain redress!

There comes a time when the CSM realises that it can no longer protect a dangerous pharmaceutical drug, even when this has been its priority for many decades. 

In 2018, Jeremy Hunt, UK's Health Secretary, although refusing to set up a compensation scheme for the families, set up another enquiry. The Cumberlege Report was published two years later, in July 2020. It concluded that the government had an ethical responsibility to provide financial help to families harmed by sodium valproate, to cover the costs of care, and detailed how a 'disjointed, siloed, unresponsive and defensive healthcare system had, for over two decades, failed to fully appreciate or act on the harmful effects of sodium valproate; but (as the Sunday Times article said) the government continue to refuse to compensate the families.

So still nothing has happened. Patients are still not being told of the dangers by doctors; they are still not getting information leaflets with their drugs; and it would seem that even the warnings given on drug boxes are being obscured (intentionally?) by pharmacists. Clearly, we are not supposed to know!

WHAT THE SUNDAY TIMES ARTICLE DOES NOT TELL US

So why has the Sunday Times suddenly decided to publish this information on sodium valproate? The mainstream media does not usually criticise its main source of income - the advertising budgets of the pharmaceutical companies! Perhaps they did so for the same reason Jeremy Hunt agreed to set up the 2018 enquiry - the evidence of patient harm has become so serious it could no longer be ignored!

1. Is Sodium Valproate safe?

The Sunday Times have not been entirely disloyal to its paymasters! Several times the article tells us that sodium valproate is a safe drug, other than for pregnant women, of course.

SODIUM VALPROATE IS MOST CERTAINLY NOT A SAFE DRUG!

The horrendous adverse drug reactions caused by sodium valporate are well known to the CME, and is part of their medical literature that everyone can see for themselves. So if anyone believes that this is a safe drug they should go to, for example, the Drugs.com website to read for themselves just how serious its so-called 'side effects' can be - even for people who are not pregnant! This is a very, very long list of very serious adverse drug reactions.

2. Is this really a one-off medical scandal?

Yet there are other issues that have not been tackled by the Sunday Times article, questions that should have been, but were not asked. Sodium valproate is the tip of a very deep iceberg. The mainstream media always likes to present these problems as 'isolated', one-off indiscretions, that are not being repeated anywhere else within pharmaceutical medicine.

Sodium valproate is not an isolated case, there many other drugs in the same situation as sodium valproate. These are drugs that are usually described by doctors as being "entirely safe", but in effect they are drugs waiting to be banned because of the patient harm they are already known to cause. And just as it has taken 50 years to ascertain that sodium valproate is dangerous, the same applies to almost any pharmaceutical drug anyone would like to mention.

And the conventional medical profession has been dishonest, for so long, about this drug, how many other drugs are being 'protected' by doctors, and the CME generally?

3. Patient Choice and Informed Consent.

The experience of women who have taken sodium valproate, as described in the Sunday Times article, clearly shows that a decision was taken NOT to inform them about possible adverse drug reactions. It might alarm them, and the paternalist CME wanted to protect them from such fear! Or perhaps they wanted to use this drug, however dangerous it was known to be, because it was all that they had to offer.

Doctors know best. All patients are expected to do is what they are told to do by the medical experts. Take the 'safe' pills - and take your chances. The danger of being given complete information is that patients might decide for themselves, they might make an"informed choice" and say "No". Patient choice is not good for the business of selling drugs. And it patients refuse, they will then discover that conventional medicine has nothing else to offer.

4. The CME, NHS, honesty and transparency

The NHS is not a transparent organisation, it is not even an honest one! It has sold out totally to pharmaceutical medicine, and conventional medicine has much to hide. We saw it recently over maternity care. Sodium valproate has demonstrated, yet again, that the NHS has clearly been involved in deliberate obfuscation, cover-up, and lies. It is clear that the CME has made a number of calculated decisions over the last 50 years:

• not to tell women about the dangers of the drug;
• doctors asked to tell pregnant women about the dangers, have failed to do so; 
• drugs packaged in plain boxes, without information leaflets;
• and if there are warnings on a box they have been (intentionally/deliberately ??) covered up with labels.

5. Bankrupting the NHS
It is the use of dangerous, patient harming drugs that is leading to the bankrupting of the NHS, and the growing awareness of the failure of conventional, or pharmaceutical medicine around the world. Sodium valproate demonstrates this as well as any other pharmaceutical drug.

• There is an illness, in this case epilepsy.
• Patients are given a drug to treat for the illness.
• There are serious adverse drug reactions (in this case, at least 20,000 children are damaged, with most requiring medical, social and economic support for the rest of their lives).

This is not a one-off problem affecting just one drug. Most illnesses/diseases can be, and often are caused by pharmaceutical drugs.

Epilepsy itself can be caused by amphetamines and other stimulant drugs, by antipsychotic and antidepressant drugs, by antibiotics and painkillers, by many vaccines, and many other pharmaceutical drugs.

This is why we are sicker now, as a nation, then we have ever been before, why chronic disease, in all its many forms, is now a unprecedented epidemic levels, and rising. 

AND THIS IS THE REAL LESSON OF SODIUM VALPROATE!