PREGNANT women taking the popular antidepressant paroxetine are
being urged to consult their doctor after the drug was linked to
The Therapeutic Goods Administration, Australia's drug watchdog,
said preliminary results in a US study of paroxetine
commonly sold as Aropax showed one in 25 babies born to
mothers on the drug had a birth defect.
Half of the defects were heart problems, but most of these were
non-life threatening. The study also found that women who took
paroxetine instead of other antidepressants during the first
trimester of pregnancy were more likely to have a child with a
Birth defects normally occur at a rate of about three in 100,
with heart defects in one in every 100 to 200 babies.
Australia's Chief Medical Officer John Horvath said women should
not abandon the drug because withdrawal symptoms could be
"It's important for the small number of women who would be
taking this drug not to panic but to review their treatment with
their doctor," he said.
A spokeswoman for GlaxoSmithKline, Nikki Capp, said the drug
company had written to doctors warning them of the study's
"The main message from the company is paroxetine shouldn't be
used in pregnancy, and pregnant women should talk to their doctor,"
Ms Capp said.
She said the US study, sponsored by GSK, reviewed statistics on
birth defects and antidepressant use in early pregnancy, and
uncovered the unexpected findings on paroxetine.
The study results are not regarded as conclusive but sent a
strong statistical signal of a problem. "It's something that was
reported on August 15 to GSK," Ms Capp said. "We told authorities
globally the next week and now we are working globally with
Aropax was launched in Australia in December 1993.
It has received bad publicity in the past year because of links
to suicide attempts and withdrawal symptoms, including withdrawal
among newborn babies whose mothers used the drug.
More than 200 million prescriptions have been written worldwide
since 1993. In Australia in the year to June 2004, more than 1.2
million government-subsidised prescriptions were filled.
Royal Australian College of GPs' Leanne Rowe said all
medications were prescribed with caution in pregnant women.
"It is well known antidepressants are category C drugs that are
suspected of causing harm in the foetus, although that has been
unknown until now because of the lack of study information."
Dr Rowe said the drug produced withdrawal symptoms and any dose
should be gradually reduced. "We don't want women to be alarmed and
stop the drug abruptly," she said. "We want them to consult their
The director of beyondblue's postnatal depression program, Anne
Buist, said many depressed women were reluctant to take drugs in
pregnancy, but up to 10 per cent had severe depression that needed
Associate Professor Buist said ideally women planning children
should talk with their doctor and possibly seek alternative
psychological treatment. "Suicide is the equal leading cause of
maternal death and untreated depression can also have a biological
effect on the foetus
these need to be weighed up in each
case," she said.
"In many cases, psychological therapies may be the most
appropriate ongoing treatment."
Australian Medical Association federal president Mukesh
Haikerwal said there had long been questions about prescribing
antidepressants to pregnant women, "but it was sometimes the lesser
of two evils".
"This study shows the risks can no longer be tolerated for this
group of women."