- Pregnant women who use Prozac and similar drugs to combat
depression could be damaging the brains of their unborn babies, according
to research.
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- The first direct evidence of a link between foetal exposure
to Prozac and disrupted neurological development has emerged in a study
of American mothers and their babies.
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- Abnormal sleeping patterns, heart rhythms and levels
of alertness were linked by researchers to drugs called selective-serotonin
re-uptake inhibitors (SSRIs), of which Prozac (fluoxetine) is the best
known.
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- An estimated 25,000 of the 600,000 babies born in England
and Wales each year are believed to have been exposed in the womb to SSRIs.
More than 15 million prescriptions for the drugs are written in Britain
every year.
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- Philip Zeskind, the research professor of paediatrics
at the University of North Carolina Chapel Hill, who led the investigation,
said: "These findings have major implications for public health.
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- "What we've found is that SSRIs disrupt the neurological
systems of children, and that this is more than just a possibility, and
we're talking about hundreds of thousands of babies being exposed to these
drugs during pregnancy."
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- Prof Zeskind, a developmental psychologist, said that
his study of 34 mothers and their babies, which appeared in the American
journal Pediatrics, was small, but he added that the results were alarming
and demanded a follow-up.
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- His team compared 17 babies born to mothers who took
the drugs Prozac, Seroxat, Zoloft or Celexa for the duration of their pregnancy,
with 17 babies born to mothers who had never taken such drugs. The two
groups of women were matched for age and social class.
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- The researchers found that more than half of the drug-exposed
newborns were rated as "very tremulous" while more than half
of the control group were "not very tremulous at all".
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- Babies exposed to the drugs tended to be locked in one
"sleep state", said Prof Zeskind. "It's well accepted that
it is normal and healthy to move around from one state to another during
sleep." They also showed "fewer of the smooth and predictable
changes in heart rate that normally occur in newborn infants".
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- Prozac and the other drugs treat depression by raising
levels of the mood-enhancing brain chemical serotonin. Prof Zeskind said:
"These babies are bathed in serotonin during a key period of their
development and we really don't know what it's doing to them or what the
long-term effects might be.
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- "It could be that they go 'cold turkey' when they
are born, or the serotonin could be having an effect on their brains, or
it could be a bit of both."
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- The professor added: "We're not saying that pregnant
women should not take the drugs, because depression is itself a big problem.
But these drugs are being given away like smarties, and this is a big problem.
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- "It's important we investigate this further and
not simply assume the drugs are safe. It took years and years for us to
realise what the effects of thalidomide were."
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- In June last year, Britain's committee on safety of medicines
said that SSRIs - with the exception of Prozac - should no longer be given
to under-18s, after evidence that they could triple a young person's risk
of suicide.
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- A month earlier, GlaxoSmithKline, the manufacturer of
the best-selling Seroxat, removed labels that claimed the drug was not
habit-forming after thousands of patients claimed that they were addicted
to it.
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- Dr Alan Cameron, a consultant obstetrician at the Queen
Mother's Hospital in Glasgow, and a spokesman for the Royal College of
Obstetricians and Gynaecologists, said: "If these drugs were having
unwanted effects in babies you would expect them to be neurodevelopmental
ones.
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- "I don't think there's any reason to panic at this
stage - but it would certainly be a good idea to investigate these findings
further. I have about 12 new patients a week, and one of them will probably
be treated for depression - and the chances are it will involve an SSRI."
GlaxoSmithKline said it would "consider this study carefully and quickly".
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- A spokesman for Lilly, the manufacturer of Prozac, said
that concerned patients should read the label on its drug packets. This
states that studies on pregnant women "do not indicate a teratogenic
[foetus-damaging] effect".
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- © Copyright of Telegraph Group Limited 2004.
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