Leading medical experts have called for women to stop taking antidepressants during pregnancy over fears that they could cause harm to unborn children.
Doctors speaking at a prestigious panel of the US drugs safety watchdog, the Food and Drugs Administration (FDA), on Monday warned that there was ‘accumulating evidence’ that antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, were linked to birth defects and may harm the developing infant brain.
One in 13 pregnant women in the UK – equivalent to around 42,000 women – were prescribed the drugs last year to treat depression and anxiety disorders.
Official NHS guidance is that antidepressants are largely safe during pregnancy, and continuing to take them is necessary for many women. The benefit for the mother usually outweighs any slightly increased risk to the unborn baby, the NHS says.
But some prominent doctors raised concerns at the FDA panel, citing a growing number of studies which suggest possible ‘harmful effects’ from taking the drugs – from withdrawal symptoms in newborns and post-partum haemorrhage in mothers, to longer-term effects for the baby including heart defects, spina bifida and autism.
They say the true picture of the risks is being ‘played down’ to women and that – at the very least – women should be better informed of the dangers before ever starting to take the pills, and especially once they become pregnant.
In his opening remarks to the panel, FDA commissioner Marty Makary said that although SSRIs were an effective treatment for depression, they ‘may be unique’ because of the effects they could have during pregnancy. ‘Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain and even the gut,’ he said during the meeting.
‘SSRIs have also been implicated in different studies to be involved in postpartum haemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects.’
Massachusetts-based obstetrician Adam Urato also told the panel, alarmingly: ‘Never before in human history have we chemically altered developing babies like this, especially the developing foetal brain, and this is happening without any real public warning and that must end.’
One in 13 pregnant women in the UK – equivalent to around 42,000 women – were prescribed the drugs last year to treat depression and anxiety disorders
Professor Joanna Moncrieff, from University College London, took part in the meeting and told The Mail on Sunday that the suggestion antidepressants were ‘not that harmful’ during pregnancy was ‘misleading’ – and that women should try, where possible, to come off the drugs during pregnancy because of the risks and ideally, before trying to conceive.
Prof Moncrieff, a vocal critic of psychiatric medicines, said: ‘We may not have absolutely watertight evidence of harm but when you’re talking about harm to pregnancy, or to unborn children, you want to err on the side of caution.
‘We shouldn’t be using them in pregnancy where they’re more likely to be harmful to the developing brain. I’m not suggesting that pregnant women who are currently taking antidepressants should flush them down the toilet, but I do think women and doctors should be better informed about the risks – both at the point of starting to take them in the first place and then at the point of when they are either pregnant, or considering becoming pregnant.
‘While I don’t want to frighten women, I do think they should not be falsely reassured that there are no worries.’
SSRIs are a class of antidepressants which includes fluoxetine, sold as Prozac, paroxetine, sold as Seroxat, and citalopram, sold as Cipramil, and were designed to improve mood by boosting levels of a ‘feel good’ chemical messenger in the brain called serotonin.
Prof Moncrieff, among others, has argued that the link between low serotonin and depression is a myth – and equally, that there is no good evidence SSRIs can increase serotonin levels.
In 2018 13.4 per cent of pregnant women in the UK were prescribed an antidepressant.
Many women opt to come off them gradually when they become pregnant, and resume taking the drugs after they give birth. But the roughly 7 per cent of pregnant women who stay on them do so for good reason. Maternal suicide – including drugs and alcohol misuse – is one of the leading causes of death among women between six weeks pregnant and a year after birth in the UK, behind stroke and heart disease. Stopping or tapering off medication can itself come with risks to mental health.
Professor Joanna Moncrieff told The Mail on Sunday that the suggestion antidepressants were ‘not that harmful’ during pregnancy was ‘misleading’
As Kay Roussos-Ross, a specialist in high-risk pregnancies at the University of Florida College of Medicine, told the FDA panel: ‘Research shows that in women who stop their medications in pregnancy, they are five times more likely to experience a relapse in their mood symptoms compared to those who continued their medications during pregnancy.’
The Royal College of Psychiatrists separately warned this week that untreated mental illness also affects unborn infants, potentially putting them at risk of premature birth and low birth weight, and problems bonding with parents which can lead to attachment issues. But – while important – this should be considered a ‘separate issue’ to the risks of drug treatments, says Dr Urato. Like most medicines, antidepressants are not routinely tested on pregnant women so there is little robust evidence around how safe they are.
There are animal studies which show an impact on birth defects and brain development.
But human studies are observational, and tend to contradict each other. Some say that means any risks are likely to be extremely small.
The most common and well-documented side effect is withdrawal symptoms in newborn babies who become dependent on the drugs in the womb, which affects about 30 per cent of births.
This might include ‘jitteriness’ in a newborn, difficulty breathing, low blood sugar and high blood pressure in the lungs, which may all result in an admission to neonatal intensive care.
These symptoms tend to be ‘typically mild and transient’, according to Prof Christiaan Vinkers, psychiatrist at Amsterdam University Medical Centre.
The most common and well-documented side effect is withdrawal symptoms in newborn babies who become dependent on the drugs in the womb
A recent Swedish study found 14.6 per cent of women taking a moderate dose of SSRIs, and 23.9 per cent taking a high dose, experienced potentially life-threatening bleeding known as post-partum haemorrhage, after giving birth.
This is because the drugs are thought to reduce the level of serotonin contained in platelets – fragments in the blood that form clots and prevent bleeding. But some studies have found the same thing in people with depression, so it is hard to distinguish whether it is down to the drugs or a result of inflammation caused by the condition itself. The UK medicines regulator, the MHRA, says the risk is thought to be ‘low’.
Other studies suggest more serious risks for unborn children, including septal heart defects – a hole between the heart’s chambers which can resolve itself or require surgery.
One large study found the antidepressant sertraline (sold as Lustral) could triple the risk (15 cases in every 1,000 births compared with five) and citalopram could double it.
Other research has particularly associated paroxetine in early pregnancy with any kind of malformation, and fluoxetine with heart defects, and women are generally recommended to switch to a different drug if they are pregnant or planning to have children.
There have been additional concerns about a link with autism from observational studies, but this evidence is ‘inconclusive’ and could be linked to depression, Prof Vinkers points out.
However, the possible link remains under ‘review’ by the MHRA. Prof Moncrieff points to ‘compelling’ evidence from animal studies showing the offspring of those given SSRIs are ‘more withdrawn and less sexually active’.
Studies linking the drugs with cleft palate and spina bifida are inconclusive.
Prof Vinkers adds: ‘It is plausible that SSRIs could influence foetal development, as serotonin plays a key role in brain formation and SSRIs cross the placenta. However, we lack direct evidence for harmful developmental effects.’
The bottom line is the risks are small – and most women who use antidepressants during pregnancy will have a healthy baby, he says.
But for Prof Moncrieff and Dr Urato, and others on the panel, the main point is that women should be better informed of the risks.
‘‘This is about having compassion for patients,’ says Dr Urato. ‘And it’s something every woman should discuss with their doctor.’
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