Times Investigation: for 40 years it's been known one drug causes disabilities when given to pregnant women

[PurgatoryOfPotholes]

www.thetimes.co.uk/article/5fcdfb18-bd72-11ec-b03a-035ba70491ca?shareToken=25fdb16d7cd8a8182562f2b6f9b01cb4

A scandal worse than thalidomide

Doctors knew in 1973 that the epilepsy drug sodium valproate posed a risk to unborn children — and ordered that warnings be removed from packets. Almost 50 years and 20,000 disabled babies later, it is still being prescribed to pregnant women

When sodium valproate was introduced as a new epilepsy drug in the 1970s, the British medical community was still reeling from that very scandal — in which hundreds of babies were born severely deformed after pregnant women were given thalidomide.

The UK’s newly formed Committee on Safety of Medicines had been designated as the key decision-making body on new medicines.

This committee — whose membership comprised some of the UK’s leading medics and was chaired by Sir Eric Scowen, professor of medicine at St Bartholomew’s Hospital in London — met to discuss sodium valproate on multiple occasions in 1972 and 1973.

They noted that the drug had shown enormous promise in controlling the terrible seizures suffered by patients, even for those whose epilepsy had proven resistant to other treatments.

Sodium valproate is still a safe and effective drug for sufferers of epilepsy, who should not stop taking it without first discussing this with their doctor.

However, the notes of the meeting show that the manufacturers, Sanofi, had raised to the committee that there were signs in animal tests that valproate could potentially be teratogenic — harmful to foetuses.

The committee concluded that the use of anti-seizure drugs such as sodium valproate was indeed “liable to produce” abnormalities. But they stated that “the risk appears to be low, and not sufficient to justify stopping the use” of the drug.

In a decision that would have disastrous consequences for thousands of families, the committee chose not to alert the public to the concerns that the drug could harm babies — concluding that since the evidence was not clear, doing so would risk causing “fruitless anxiety” to patients.

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”.

The committee’s decision not to warn women of the risks was probably “influenced by the paternalistic nature of society at the time”, believes Dr Rebecca Bromley, a paediatric neuropsychologist at the University of Manchester.

She believes the committee did not appear to consider the need for “women to have an informed say in their treatment”. Instead, the effect of the decision was to “leave patients fully in the dark about the risk that their medicine might carry”.

(Continues)

As a result, about six babies every month are being born in the UK having been exposed to the drug.

An investigation by The Sunday Times has found that the drug is still being handed out to women in plain packets with the information leaflets missing, or with stickers over the warnings.

Continues

www.thetimes.co.uk/article/5fcdfb18-bd72-11ec-b03a-035ba70491ca?shareToken=25fdb16d7cd8a8182562f2b6f9b01cb4

You need to read the full thing to fully grasp the scale of this.

Thank you for the link. I heard this discussed briefly on the radio and it’s shocking and appalling. Those poor poor families, it’s criminal what’s happened to these women who were deliberately kept in the dark or blatantly lied to. Enraging and heartbreaking.

That's an absolutely shocking read and it beggars belief that even now women are receiving their pills in plain boxes with the medication information insert removed or in some cases, pharmacies are actively sticking labels over warnings on the boxes.

I found this horrifying (though there were many other bits which were also horrifying) -

'That was the first time we had ever heard that valproate could harm babies,” she said. It later emerged that doctors had secretly diagnosed Lee with foetal valproate syndrome as a baby — but had never told her about it.

If she had known, Williams might have been able to prevent her second son from suffering the same fate. “I was angry,” she said. “Why had no one ever warned us?”

I just can’t believe the amount of people complicit in this- from the manufacturer to the government to the GPs and pharmacists. Absolutely shocking

One family has five children affected. So much needless suffering.

Inaccurate as to current practice. Pharmacies will not issue the drug to a woman of child bearing age (and yes, this includes girls) unless there is an up to date prevent form, signed by the patient as well as the clinician, confirming they know the risks and are taking all steps to avoid pregnancy.

It was truly a scandal. Now it's a way to try to avoid punishing the small number of women for whom this is the only drug that controls their epilepsy.

www.gov.uk/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials

Surely this is criminal? Knowing the risks and deliberately hiding them from pregnant women. It's utterly outrageous.

I worked alongside a woman in the 90s who was on this drug. Her daughter was born with tiny feet and didn't walk properly for years. We lost touch and I often wonder about her now.

Dsd takes this, I've just checked the packet, it's clearly stated on the leaflet.

[quote nocoolnamesleft]Inaccurate as to current practice. Pharmacies will not issue the drug to a woman of child bearing age (and yes, this includes girls) unless there is an up to date prevent form, signed by the patient as well as the clinician, confirming they know the risks and are taking all steps to avoid pregnancy.

It was truly a scandal. Now it's a way to try to avoid punishing the small number of women for whom this is the only drug that controls their epilepsy.

www.gov.uk/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials[/quote]
Ah, there is a new guideline so it couldn't still be happening. What you describe is already addressed in the Times investigation.

Still no warnings

Patricia Alexander holds in her hands a plain packet. Inside are two blister packs containing sodium valproate.

This pack was given to her in January of this year. It has no patient safety information leaflet inside.

“Sometimes you just get a white box,” she said. “They are supposed to put the patient information leaflet inside and a card that warns you of the risks, but they don’t.

“The fact I am getting the boxes like this, because they have split the dose, means someone else is as well.”

Perhaps the most damning finding of Cumberlege’s report was her warning that hundreds of women were still taking sodium valproate with no knowledge of the risks to their unborn babies.

Evidence suggests that this still continues to this day — with the drug being handed to pregnant women without proper warnings.

The pack given to Alexander in January states on the front that if you are pregnant or plan to become pregnant, you must speak to your doctor about taking the medication and read the leaflet for more details.

“But there is no leaflet,” she said. “There is nothing in the box but 22 tablets. It makes me so angry.”

After she was given them, Alexander took photographs of the boxes and shared them online.

Other women did the same. Some had received the drugs in plain boxes. Others showed boxes with pharmacy labels stuck over the pregnancy warnings.

The matter of the drugs still being handed out in plain packaging, without the appropriate warnings, has been acknowledged by the Department of Health and Social Care.

It has admitted that “evidence continues to emerge suggesting many women remain unaware of the significant risks posed to their unborn baby should they fall pregnant while taking sodium valproate”.

It launched a consultation in November on proposals to ensure sodium valproate was always dispensed in the original manufacturer’s packaging “to support increased patient safety” — but the government has yet to respond.

An NHS England spokesman said it had established an expert group to help reduce by 50 per cent next year the use of sodium valproate by women who can get pregnant, and had written to all women and girls aged 12 to 55 in England who take the medication to remind them of risks.

But the medicines regulator has admitted warnings are still not getting through.

Dr Alison Cave, chief safety officer for the Medicines and Healthcare products Regulatory Agency (MHRA) said work was ongoing on safer use of sodium valproate and to minimise prescribing.

She said the MHRA was now working to ensure the drug was dispensed in the original packaging with the safety information inside.

“If there are examples where this information has not been provided, we would investigate this,” she said.

She added that the drug “should not be taken by any individual of child-bearing potential unless they have a pregnancy prevention programme in place, which includes use of effective contraception”.

She also said that women on sodium valproate were now required to sign annual risk-acknowledgement forms together with their healthcare professional “as their circumstances regarding the risk of pregnancy may change”. Patients who spoke to The Sunday Times disputed whether these measures were in place across the board.

[quote nocoolnamesleft]Inaccurate as to current practice. Pharmacies will not issue the drug to a woman of child bearing age (and yes, this includes girls) unless there is an up to date prevent form, signed by the patient as well as the clinician, confirming they know the risks and are taking all steps to avoid pregnancy.

It was truly a scandal. Now it's a way to try to avoid punishing the small number of women for whom this is the only drug that controls their epilepsy.

www.gov.uk/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials[/quote]
In that link, it says -

'Evidence from patient surveys suggest that there are still gaps in the implementation of the pregnancy prevention programme, for example women of childbearing potential on valproate medicines who have not been asked to sign the Annual Risk Acknowledgement Form. All girls and women of childbearing potential using valproate medicines should be reviewed at least annually to ensure that the conditions are met.'

Is the Prevent form part of the Annual Risk Acknowledgement Form or is it something separate?

I have epilepsy and was not prescribed this specifically because of the risks if I planned to have children in the future. I have also had conversations with an epilepsy and pregnancy specialist (I've just got into my 2nd trimester) and she has specifically told me that my medication is the most safe, but sodium volproate is not classed as safe in pregnancy.

I will read this article tomorrow, as I don't currently understand why I have been told this for 17 years while other women have had no warning at all.

From the NHS website:
Sodium valproate is not recommended if there's a chance you could become pregnant. If you're taking sodium valproate and want to start a family, it's important to talk your doctor as soon as possible. This is because taking sodium valproate while pregnant can harm your baby.

I know in the early 80s dm's friend didn't have children because she was epileptic. The risk of not taking the drug was too high to stop, and she knew that the drug caused abnormalities in pregnancy. I remember it being talked about freely in front of me.
So it has been known and talked about since then.

Some of the statements in the article need to be unpicked. For example she states that her dd needs splints which take "weeks on the NHS" so she wants to go private.
My dd was born missing a hand (not medication related, if it's medication related it almost always effects both sides in some way, normally both arms, or both legs or all four limbs. Genetics also tends to effect more than one limb. There are around 60 children a year born with a single limb difference that have no known reason. There are theories but no concrete knowledge.)
When she wants a prosthesis, it takes weeks. But going private will not effect that unless she is taking effectively a less good one.
To get a new prosthesis, she needs to go to have a cast made of her arm, then go back 2-3 weeks later to be fitted. Sometimes she needs a further appointment before she can bring it home. It can easily be a couple of months from start to finish.
Prosthetics are medical so cannot be reused from person to person. It's not just a case of walking into the hospital and trying them on like shoes.
If we went private we could get a generic one like some of the 3-D printed ones. They're not as good and less comfortable too. (and I suspect break easier too)
I suspect the same is true of the splints.

I think also calling it a scandal greater than Thalidomide is playing down the effects of Thalidomide. It's estimated that in the region of 100k babies were effected in just a few years, 24k in the UK. Many were still born or died very shortly after birth. It was only used from 1958-1961 in the UK.
Thalidomide is still used today for treatment for various things including cancer, and there are still babies born effected by it, mostly in Brazil, I think, where it is used to treat leprosy.

‘nocoolnamesleft

Inaccurate as to current practice. Pharmacies will not issue the drug to a woman of child bearing age (and yes, this includes girls) unless there is an up to date prevent form, signed by the patient as well as the clinician, confirming they know the risks and are taking all steps to avoid pregnancy.

It was truly a scandal. Now it's a way to try to avoid punishing the small number of women for whom this is the only drug that controls their epilepsy.

www.gov.uk/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials‘

Yes where I work this is discussed with women

That is appalling, OP. Thanks for sharing.

I work in pharmacy, we would always ensure the pregnancy warnings are visible on the pack and that all the inserts and information leaflets were there too.

In some cases it is necessary to dispense medicine into plain white boxes - usually if the number of tablets prescribed isn't a round pack size but we would always make sure to print off the warnings and patient information leaflet and put them in the box.

I'm genuinely shocked at the article - though if I remember rightly there are actually pregnancy warnings printed on the blisters as well, they have them flipped over in the picture but part of the warning is actually visible where they have peeled the foil back to remove the tablet. It's quite an obvious graphic with a picture of a pregnant woman behind a 🚫.

That said, they should never have been prescribed the drug in the first place - other teratogenic drugs are not prescribed without the patient first being tested for pregnancy then signing up to a Pregancy Prevention programme, I don't understand why this isn't happening with Sodium Valproate.

I suspect that as with all other massive overhauls, it's going to take months, maybe years, to roll it out across the country. There will be people in prescribing doing it the way it has "always been done" without realising there has been a policy change.

Years ago I used to read the forums on Epilepsy Action (I think) and quite a few people on there hadn't seen a Consultant for years. Their care and medication was overseen by a GP. I was very shocked by this as I've been controlled for a long time but still have a yearly check in with my Consultant, plus now I have regular phone calls with a nurse who specialises in epilepsy and pregnancy.

I've read the article on the Times app and am shocked by the postcode lottery that seems to have determined whether you were warned or not. I have known the risks of all the different epilepsy medications during pregnancy for 17 years, while other women have been told nothing.

Shaun Lintern is excellent about patient safety. He has been dogged in following up the maternity scandals and has been a huge support to the affected families.

It’s one of the most fucked up things I think I’ve read about in recent history. I was put on it as a 15/16 (2010) year old but luckily saw another neurologist who changed it for a different less dangerous medication as I was old enough to have a baby.

Those poor families and all the lies!

My son had Fetal Valproate Syndrome. He has ASD, ADD, 3 types of Epilepsy not inherited from me, Dyspraxia and Cognitive Learning Disability. He also has a gap between the 2 halves of his brain that should have closed at birth and didn't. He will always need support and I worry about him and his care after we have died.

I have been involved in the campaign and you would not believe how badly women have been treated.

It has been common place for information to have been withheld from women who asked about safety in pregnancy, side effects (of which there are many) and the misinformation around.

We know of hundreds of women who have never received a Patient Information Leaflet and only get their medication in white boxes - no matter what practice pharmacies are expected to follow, not all of them do so.

My medication was changed after my son was diagnosed - practitioners couldn't act quickly enough. The government are shits - they have caused this, they are letting it continue and they won't agree to redress to ensure our children can receive support once their parents are dead!

*has, not had!

That sounds terrible for you to have gone through, charmatt. How old is your son now? And, if you don’t mind me asking, how do you manage not to be burnt up with anger?

He's 21. We realised when he was about 6 months that he wasn't developing as he should. He missed his miles stones at 9 months and I realised at the same time that he had a sight problem (optic nerve hypoplasia). I read a news article about Valproate that felt like it was describing him and I knew in my gut he had been affected. We'd asked so many questions prior to pregnancy and even had to have fertility treatment to have him - Valproate caused PCOS in me - and all I kept being told was that we would have a scan at 20 weeks for cleft palette and spina bifida but the risk was incredibly low and I was better off on Valproate than off it. The 20 week scan came back clear!

I did my own research (in the days when the internet was not as useful) and took a stack of papers to the GP with me. He sat and listened and said that he had never heard of Fetal Valproate Syndrome.....but he believed me! He referred my son to a geneticist who was great and diagnosed him at 18 months.

I refuse to be consumed by the anger and channel my feelings to gain support for him, etc, though it's hard work!

At the age of 4 he started with jerks which we were told was a tic. However, they kept getting worse and we were sure he was having myoclonic jerks. These concerns were dismissed continually until we paid to see a private consultant in London who get a referral to GOSH. He had an EEG and was diagnosed with Juvenile Myoclonic Epilepsy with absences - at his worst he was having over 40 myoclonic seizures a day.

Once home, the hospital couldn't get him in for an MRI fast enough, which was when the gap in his brain was diagnosed. He was also diagnosed with ASD, dyspraxia and ADD after long assessments.

He also had temporal lobe epilepsy and the point at which I cried in public about it was when they prescribed Sodium Valproate to control them. We have since had him transferred to another medication that has been successful. Having him prescribed Sodium Valproate was too much of a kick in the guts for me. It's called a 'dirty' drug by several specialists because of the damage it can cause and the side effects.

If I was angry about it all the time I'd break down and that wouldn't help him. Throughout it all we have said that he is the important one and it's not about how we feel about it. That way we make decisions that are best for him.

When they moved me to another medication, my hair stopped falling out and I was not tired any more. They also realised with blood tests that it had been slowly damaging my liver. My LFTs didn't return to normal for 5 years after coming off it.

I was never told that the PCOS was caused by the Valproate and 6 and a half years later I found myself unexpectedly pregnant with my daughter. She has the same father, was born at the same hospital with the same midwife. She is 100% healthy and has no medical or learning problems. She has had to adapt to live with a sibling with lots of need, but she is entitled to a life too. We can't put the responsibility of looking after him onto her, which is why we need redress. He needs an income to provide for care when we are no longer here. The thought that he won't have parents to look after him at some point kills me. I know my daughter will look out for him, but he'll need professional help as he ages.

We were part of a mass case against the drug company, and we were one of the test cases because we have a child affected and another who is not now I'm on different medication. This was before we uncovered the government cover up in the

....sorry posted too soon!

page 2:

This was before the government cover up was uncovered by the group I am part of. We had been granted legal aid to prepare the case, which took 8 years to prepare. The government withdrew the legal aid 3 weeks before the case started at the Royal Courts of Justice and we had to drop it.

The Cumberlege Review and all the recommendations has been accepted by the government except for the recommendation for redress. However, we can't stop until they agree to this too!

I do worry about him all the time, and as I've said, the thought of him being here when we aren't kills me! That's what spurs me on.....

Thank you for sharing that. It sounds like it could have been incredibly draining at points. The legal aid being stopped must have been a huge kick in the teeth.

I know people say that guidelines have changed but my family member was prescribed it as a mood stabiliser. Not for epilepsy. Child bearing age and it was only when I looked into it that I realised she shouldn’t be on it. She only came off it a few years ago.