The Truth about Pills and Pregnancy Panorama

during pregnancy, but could they be risking the health of their unborn

child? She could be mentally, physically disabled and she could

have no quality of life. Even doctors don't know if most

prescription drugs will be safe during pregnancy.

If David's condition was preventible and it wasn't prevented, then that's

really, really awful. thalidomide scandal was meant to

have improved safety monitoring, but could another drug have damaged far

more children? So you really do think it's much bigger than

thalidomide? A lot, lot bigger. That's why there needs to be a

public inquiry because we don't know. The evidence that other common

drugs are linked to heart defects in babies. How does no-one know this is

going on? How much do we really know about the safety of pills in

She and her partner are moving to a bigger flat in Croydon before the

arrival of their first baby. They are having a girl and plan to

call her Emily. But Jo, a nursery teacher, is facing

a stark reality. She has epilepsy. So to control her seizures, she

needs to take powerful medicine. I wasn't controlled, I wouldn't be

able to do the job that I do. If my tablets didn't work, it could ruin

my life. But the pills that protect her

health could have harmed the baby she's carrying.

Jo's pregnancy wasn't planned. She was four weeks pregnant and still

taking the drug before she realised. Was there a discussion at that stage

that you should maybe try a different one? No, because after the

first four to eight weeks, the tablets would have had the effect on

the foetus anyway. That's quite a difficult thought to deal with.

Especially not knowing that, you know, you're already pregnant.

So far, all Jo's scans and tests have come back clear. But not all

the disabilities limped to the drug she's taken can be detected in

advance. We'll just have to wait and see and

get her checked out once she's born and then keep getting regular

checks. It's not just women with epilepsy

who find themselves in this situation.

Most women take medicine in pregnancy, often before they realise

they are expecting. And that's the key time when the

baby's heart, brain and other organs are forming. You might expect that

all medicines have been thoroughly tested to show that they are safe

during pregnancy, but it's not considered ethical to test drugs on

pregnant women, so doctors simply don't know for sure whether most of

the drugs they prescribe to pregnant women could harm their baby.

For families, the problems that can lead to can be life-changing.

good girl... Phoebe Vaggers has a lot to deal

with for a four-year-old. She has poor eye sight, struggles with

speech and learning, her hearing is poor. Very beautiful.Her mum,

Gemma, has epilepsy, and like Jo Burrows, took a drug called epilim

throughout her pregnancy. If I don't take that drug, I can say

to you now 100% I will have a seizure. I could be walking across

the road, have a seizure and be knocked over. Because I don't get

any warning, I don't know when it's going top what, so it's very

dangerous. The benefits to Gemma of taking her

medicine are clear. But before getting pregnant, she and her

husband wanted to know whether it could pose a risk to the baby.

We thought we'd do it the proper way, get proper medical advice

because obviously you were on medication, so we went to see a

urologist. They say the epilepsy specialist

told them there was a small chance the baby could have a cleft palate,

spina bifida wn Down's Syndrome, risks that are well documented. On

balance, risks they felt prepared to take. Pf

We came away from that appointment feeling very happy didn't we and

confident. The last thing he said was, you are young, healthy, we see

no reason why you shouldn't go on to have another happy, healthy baby and

it left her feeling great. Yes. Phoebe was born, she didn't have any

of the problems they'd been warned about. It was months before they

realised something was wrong. She wouldn't sit up. Then she

wouldn't crawl. It was these major milestones that she just wasn't

hitting. No-one made the link with epilim. So Gemma was still taking

the drug when they tried for another baby.

It was only when Gemma was five months pregnant with her second

child, Charlie, that she discovered her daughter's problems had been

caused by the pills she was taking. Today, they are going to see the

specialist who broke that bad news to them three years ago. I'm going

to hold your hands, OK. Looking at her hands again. Her finger is a bit

tapering, something we sometimes see. The other side not so much

which is good. Dr Peter Turnpenny suspected straightaway that Phoebe's

problems had been caused by epilim. It was a situation where they bring

the child into the room and, you know, before they've sat in the

chair you have recognised the problems, or the features, that are

evident in the child, social appearance.

He diagnosed Phoebe with foetal valporate syndrome, a range of

physical and dwromental problems caused by exposure to epilim. Gemma

and James had never heard of the syndrome.

And there was more bad news. There was a high chance the baby she

was carrying could have the condition too.

It was quite difficult. Obviously, I was pregnant with Charlie, so it was

really hard. Charlie was later diagnosed with the same syndrome.

Like Phoebe, it's had a major impact on his life.

He's developed mentally delayed by about 18 months. He's not talking,

not putting sentences together. His understanding is there, but there's

Charlie as normal a life as possible, but they don't yet know

what the future holds for them. very difficult to know. I have

certainly seen some young adults who have been exposed to this drug who

struggle with independent living. this is a life-long condition for

some people? I think for some, the more severe end of the spectrum,

that's undoubtedly the case. Do you want to stand next to mum and we'll

try and measure your head? Excellent. Good fella. Dr Turnpenny

says up to 20,000 children could have been damaged by epilim. The

Vaggers can't turn the clock back, but they are sure they would have

done things differently if they'd been able to make an informed

choice. I can't be on no drug, which is

obviously the ideal scenario, but we've tried everything else we could

have before having a child on epilim.

New evidence about epilim eats impact on the mental development of

children is still e-Americaning, even though the drug's been provided

for 40ure years in the UK. research we have done seems to show

that more children have developmental delay and even autism

would be in the spectrum. Figures of up to 30% of children being affected

are being quoted. A substantial risk? A huge risk.Are you surprised

it's taken so long for this risk to become apparent? Very surprised. 40

years this drug has been prescribed to thousands, the forgot tens or

hundreds of thousands of women worldwide.

How can it have taken so long to discover that a widely used drug has

harmed up to one in three babies exposed to it during pregnancy?

Janet Williams says 25 years ago mothers like her didn't know of any

risks. She lives near Blackpool with her

two grown-up sons, both of whom have foetal valporate syndrome.

22-year-old Philip is more seriously affected. Philip in particular, it's

constant reminders of things. Like in the bathroom here, we have this

about not forgetting to wash and brush his teeth. If that's not

there, when he comes in in the morning, he just totally forgets.

What sort of challenges do you face? Memory for one. I haven't got a good

one. You have to tell me things three times before it actually sinks

in. And even then, I try not to forget what you just said.

From her bedroom, Janet now runs a campaign group with Emma, another

mum whose children have been damaged by the drug.

They think epilim's manufacturer should take some responsibility

because they say the company only began to give women adequate

warnings in the mid 1990s. To put the onus on the prescriber I

think is all wrong really, it's the drug company that should be bearing

the brunt of this, especially for the older kids, definitely.

Some families tried to sue the drug company, Sanofi Aventis, but the

case collapsed three years ago. The company says it warned doctors

from the beginning. Now, Janet and Emma want a full public inquiry.

This drug's been out on the market for 40 years this year. It's come to

a point now where the public inquiry is a necessity to find out what's

happened, why it's happened, why the system's failed. Sanofi Aventis told

company, prescribers or the medicines regulator, a medical

tragedy on this scale was never supposed to happen again.

In the 1960s, thousands of babies were born with serious deformities

because of a drug called thalidomide their mothers took during pregnancy.

Nick Dobrik is one of the few hundred remaining adult survivors in

the UK. He and the thalidomide Trust are shocked by the largely hidden

damage caused by epilim. Now, they too, are campaigning for a public

inquiry. It was thought at the time a tragedy

like thalidomide would never happen again. How wrong we were. I think

the epilim story is a much greater disaster than even the thalidomide

story. To think this tragedy on a scale may be as much as 20 times

larger than thalidomide has happened and gone unnoticed, it's incredible.

So you really do think it's much bigger than thalidomide? A lot, lot

bigger, and that's why there needs to be a public inquiry because we

don't know the facts. Around a thousand babies in the UK

were damaged by thalidomide. Up to 20,000 may have been harmed by

epilim. Why hasn't this been picked up much

sooner by the medicines regulator? Let's be clear, it's quite

inappropriate to compare epilim, sodium valporate with thalidomide?

Why? We should treat with caution the estimates you have quoted

because of the fact that use has declined with the warnings we have

given and the fact that people have taken on board the fact that epilim

should not be used unless there is no safe effective alternative in

pregnancy. When we seen your research saying there's a up with in

three chance almost of a baby being borned with developmental problems,

it shouldn't take 40 years for that evidence to emerge, should it?

Evidence emerges over time, and the link between a drug exposure in

pregnancy and a developing child takes time to gather.

After the thalidomide tragedy, the Government set up an early warning

system that's meant to quickly flag up side effects when a medicine is

in general use. So if a doctor even suspects that a drug has caused

harm, they are meant to fill in a yellow card report like this and

send it to the medicines regulate who pools them together in a central

database. The system is voluntary and in practice, doctors rarely fill

out yellow cards. When a baby is born with a disability, they don't

always make a link to medicine the mum took in early pregnancy.

The yellow card system, which really relies on a systemattic way on

individual clinicians reporting problems, that's a really limited

way to be able to understand these problems. Some tragic event happens

with a baby's born with a horrible life ending cardiovascular anomaly

and you just think, how awful that is, and you don't think, I wonder if

it was due to X nine months ago. physical defects were painfully

obvious from birth with thalidomide. But Phoebe and Charlie's problems

weren't diagnosed for a full year. Neither case was reported to the

regulator. Did you or any of the doctors

involved fill out a yellow card? It was only literally in recent

weeks I've even heard of the yellow card.

We found another 14 cases where babies were born with serious health

problems after their mums took prescription medicines during

pregnancy. The MHRA says the yellow card system is the best in the world

in picking up suspected safety problems, but not these cases. All

their families say they weren't reported to the regulator.

This isn't just about the safety of epilepsy medication. Most of the

drugs used during pregnancy haven't shown to be unsafe for the unborn

child. And now there's growing concern about one of the most widely

prescribed types of drugs. Antidepressants.

What's that? David Wilson's spent the first eight

months of his life in and out of hospital.

When his mum Anna had her 20 week scan, doctors realised he had a

serious heart problem. They said he'd need surgery as soon

as he was born. There is just so much when he was

born, about whether he would survive a day and the first operation and we

just didn't know. 11 days old when he had his first surgery, and he

didn't cope very well after that, became very swollen because there

was too much blood going into his lungs and his whole body was

swollen. He had a second operation at 16 days old.

David with us hooked up to machines for five weeks. He'll need more open

heart surgery before he starts school.

Tock fors say he may not live beyond He's got a lot of suffering ahead of

him. We know that. That's a certainty. And that's pretty awful.

Four years before she got pregnant, Anna went to see her GP because she

was suffering from anxiety. He prescribed the antidepressant,

Cipramil. I had quite a tough time at work, a lot of stress. My mum had

been quite ill as well and it just all had taken its toll. It worked a

treat, just calmed everything right down and I got back to being myself.

Citalopram is one of a group of commonly used antidepressants used

by up to one in six women taking pills. When Anna first thought about

getting pregnant, she asked her dobling for if it was OK to stay on

the drug. He said it was fine. In the event I had a miscarriage with

that baby and we went to see the doctor after the miscarriage and

there was no connection made with citalopram.

She went on to have a healthy son, Liam. So she had no worries about

getting pregnant again on the drug. After David was born, she did ask

what might have caused his heart problem. We did meet with a

cardiologist at one of the scan appointments and he explained that,

as far as he knew, there was no kind of environmental factors or it

wasn't because of anything that we, as parents, had done, it was just

one of those things, couldn't be prevented.

What they didn't know was that David's heart problems might have

been caused by the antidepressant she was taking.

Three years earlier, on the other side of the Atlantic, a landmark

legal battle had highlighted safety problems with another SSRI

antidepressant called paroxetine. A mum from Philadelphia took the drug

company to court because she believed it caused her son to have a

serious heart defect. Her son, Lyam, is seven now and

small for his age. You wouldn't know that he almost died when he was

born. So this is the first operation.

Oh, my goodness. How long was he like that? Four months.Were you

able to pick him up when he was connected to all these things?

just hold his hand and touch his little face and just, you know, sing

to him, read to him when he was awake.

When Michelle David got pregnant, she'd been on paroxetine for a few

months, prescribed for anxiety. was just slight anxiety, something

I've had my whole life. Were you told anything about taking the drug

during pregnancy? No.Mush shell took paroxetine for the first three

months of her pregnancy, just as Lyam's vital organs were forming. He

was born with a valve missing in his heart and needed life-saving

surgery. They had to stop his heart and shock

it to get it going again once it was repaired and then you are just

hoping and praying that, you know, he makes it out alive.

Michelle began to wonder if her medication had caused his problems.

Eventually, she found herself suing one of the world's biggest drug

companies, the British firm, GlaxoSmithKline.

Through a court order, her lawyers got access to GSK's confidential

archive. What they found there was disturbing

evidence about paroxetine's safety during pregnancy from studies done

on animals. It may not be ethical to test drugs

on pregnant women, but they are tested on animals before they can be

approved for use in humans. When Michelle David's case came to this

court in Philadelphia, shocking evidence was revealed from trials

carried out by the manufacturer more than 30 years ago.

Two groups of pregnant rats were compared. Those given paroxetine

gave birth to a large number of dead babies. Those not given the drug all

gave birth to live babies. In an internal report, a GSK

scientist concluded: There remains the possibility that this compound

could be t oh ritogenic at high levels, in other words" paroxetine

might be harmful to babies in the womb. The problem with that is,

internally, nobody responded to that, nobody did any studies, nobody

tried to figure out whether or not the drug was inducing birth defects,

they just simply took it to market. So there was this evidence as far

back as the 80s that paroxetine might cause birth defects in animals

at least? Without question. I was shocked. As I said, through

the 30 days, I heard a lot of the evidence. It was just

heart-breaking. I kind of felt like, how does no-one know that this is

going on? Having heard all of the evidence,

the jury decided that paroxetine had caused Lyam's heart defect and

awarded him compensation of �2. 5 million dollars.

Since it happened in 2009, GlaxoSmithKline hasn't appealed the

verdict and, without admitting liability, the company has gone on

to settle out of court more than 1,000 paroxetine heart defect cases

in the US, paying more than $1 billion to affected families.

Michelle David feels the result was justice, not simply for her own son.

We were able to help so many other families, hundreds of families. Yes,

that was really important. warn against taking paroxetine in

early pregnancy, but not the other SSRI antidepressants. We found eight

babies born with heart defects to mums who took a range of SSRIs while

pregnant. The evidence about their risks is still not clear cut.

But advice to doctors is about to be updated to take account of research

that suggests SSRIs, as a group, could be linked to birth defects,

including heart problems. The available evidence suggests that

there is a risk associated with the SSRIs. We make quite a lot of effort

really to discourage women from smoking or drinking even small

amounts of alcohol in pregnancy and yet we are perhaps not saying the

same about antidepressant medication which is going to be carrying

similar, if not greater risks. There's between a one in a 200

chance of babies being born with birth defects if the mother took

SSRI. The Professor says that could rise to four in 200. For women

mildly depressed, I don't think the risks are worth taking. Of course, a

lot of pregnancies are unplanned. Do you think prescribers are giving

enough thought to the risks when they prescribe these drugs to women

of child bearing age? I think it's not just when a woman who's pregnant

is sitting in front of you. I think it needs to be thought about with a

woman who could get pregnant and that's the large majority of women

aged between 15 and 45. Anna Wilson wasn't warned of an

increased risk before she became pregnant when the SSRI was taken by

her. Her son was born with a serious heart condition. If David's

condition was preventible and it wasn't prevented, that's really,

really awful. If somebody gave me a choice and said there's a risk, I

would have stopped taking those tablets in a flash. Even the if you

were told there was only a very small risk to the baby? I still

wouldn't have taken that risk. You know, I wasn't given the choice.

Lundbeck, the company that makes widely prescribed for two decades.

Like all drugs, they couldn't be tested on pregnant women before they

calm to the market. But is there a better way to monitor the safety of

medicines during pregnancy so that problems can be pick #ed up earlier?

In Belfast, there's a central registry that tracks babies whose

mums took epilepsy medication while pregnant. It's voluntary, but the

man who runs it says it has quickly identified safety problems and could

easily be extended to cover all drugs.

What I think is required would be mandatory registration of drugs

taken during pregnancy. When a woman books in in the obstetric unit, it's

routine for the midwife to take a history and to note down what drugs

that woman's taken. How difficult would it be to have a tear-off sheet

to accumulate data? It's not rocket science. Not rocket science, but

it's still not happening. The MHRA says it's improving the way

it monitors the safety of drugs taken in pregnancy.

For every medicine that may be used in a woman of child-bearing

potential, there will be a plan to gather that data. Increasingly, we

use clinical records to limp the mother's health record with the

baby's health record and that opens up the opportunity, if we can link

to maternity units and hospital records, to have a very complete

picture of the drugs that the foetus has been exposed to and its

development. Back at Croydon, all that nursery

teacher Jo Burrows can do is wait and hope that her baby has been

unaffected by the medicine she's taking.

I've worked with special needs children and if it happens, it

happens, we are still going to love her no matter what.

Protecting a mother's health without damaging her baby can be a difficult

balance, but until women know the full risks, how can they make an

informed choice about the pills they take during pregnancy?

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