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Psychiatrists
and GPs warned pregnant women on Seroxat could have deformed children
December
21, 2005
Psychiatrists
and GPs have been warned that pregnant women on the Seroxat antidepressant
could have deformed children.
Doctors
were this month sent a letter from the drug regulator, the Medicines
and Healthcare Products Regulatory Agency (MHRA), alerting them
to a possible new risk of the drug, also known as paroxetine.
The letter read: “New data
from Denmark, Sweden and the US represent a potential signal of
an increased risk of congenital malformations following maternal
use of paroxetine in the first trimester.
"The new studies suggest that
in women taking paroxetine in the first trimester the risk of birth
defects in the newborn may increase from 3% to around 4% for all
congenital malformations and from 1% to around 2% for congenital
heart malformations.
"However, other epidemiological
studies have not supported such an increased risk.
"All
available data are being actively investigated by the Commission
on Human Medicines and the MHRA.
"Any
increased risk is small and needs to be considered in the context
of the potentially greater risk to the foetus that may result from
the mother’s depression remaining untreated."
The
MHRA said, if it deems necessary, it will issue new formal guidance.
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