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Last Updated: Tuesday, 20 June 2006, 09:52 GMT 10:52 UK
Doubt over antidepressant risks
By Caroline Ryan
BBC News, Prague

Seroxat
Seroxat has been linked to poor development
A common antidepressant may be safe for pregnant women to use, despite fears it could put babies at risk.

Seroxat had been linked to heart abnormalities, and the US watchdog issued a warning on the link last year.

But German researchers told a European fertility conference they had found no increased risk, and said women may have terminated pregnancies unnecessarily.

Experts say women with depression should talk to their doctor to find out what is best for them.

The science on Seroxat and pregnancy isn't conclusive either way
Sophie Corlett

Pregnancies in women with untreated depression carry their own risks, including poor foetal development, premature birth and intellectual development problems.

The US Food and Drug Administration issued its warning on the drug - also known as paroxetine - on the basis of unpublished research from the makers, GlaxoSmithKline, which has since been revised.

The UK's Medicines and Healthcare products Regulatory Agency said the drug should only be used in pregnancy when the benefits to the mother outweigh any potential risks to the foetus.

Terminations

The research carried out by the University of Ulm team studied 119 women treated with Seroxat between 1999 and 2005 and compared their pregnancies to 645 women not exposed to the drug.

Three abnormalities were reported after exposure to the drug: club feet, a large port wine mark and neck muscle spasms.

But, in the non-drug group, there was a similar rate of abnormalities, with 25 out of 557 babies affected.

The only way in which the Seroxat group differed was that more decided to terminate their pregnancies.

Eighteen out of 119 on the drug, just over 15%, opted to terminate their pregnancy compared to 17 out of 645 women in the control group (2.6%).

The researchers said most chose a termination because of their depression, but also because of confusion over the potential risk from the drug.

'Information is crucial'

Dr Wolfgang Paulus, director of the Institute of Reproductive Toxicology at the University of Ulm, who led the research, said: "We found that the rate of congenital abnormalities was not increased after using paroxetine in early pregnancy.

"Women and their physicians should discuss this information and make an informed decision, whether or not to continue with paroxetine during pregnancy.

"Concerned patients can be offered ultrasound and echocardiogram, which can rule out foetal cardiac problems in early pregnancy.

"Antidepressants should never be stopped abruptly as this can have serious ramifications for the mother."

Sophie Corlett, policy director of mental health charity Mind, said: "The science on Seroxat and pregnancy isn't conclusive either way.

"It's crucial that women are given all the information and options possible, so they can best weigh up the risks and benefits of taking this drug when they're expecting a baby.

"We also don't know yet what the effects could be of passing on any antidepressants through breastfeeding once the baby has been born."

She added: "Many unpleasant side-effects have been reported with Seroxat, so it's not just pregnant women who should be cautious when taking it.

"Mind fully supports the researchers' call for close vigilance whenever Seroxat is prescribed."

Marjorie Wallace, chief executive of the mental health charity SANE, said the risks and benefits of all medicines had to be balanced against each other.

"Any evidence linking use of a drug to damage to the unborn baby must be taken very seriously but, while remaining acutely aware of the risks anti-depressants may pose to some individuals, we must be careful not to deprive people of vital medications."


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