Paxil Study Contradicts USA Warning That An Antidepressant Can Cause Congenital

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Paxil Study Contradicts USA Warning That An Antidepressant Can Cause

Congenital Abnormalities

http://www.medicalnewstoday.com/medicalnews.php?newsid=45509

A study carried out by German researchers has failed to show that a

popular antidepressant, paroxetine®, (PAXIL) causes congenital

abnormalities if taken by pregnant women, the 22nd annual conference

of the European Society of Human Reproduction and Embryology heard.

Dr. Wolfgang us said the results were important because they

contradicted a warning issued by the US Food and Drug Administration

in October 2005 that the use of paroxetine (brand names: Seroxat®,

Paxil®, Aropax®, Deroxat® or Pondera®) could increase the risk of

major congenital abnormalities. The warning may have caused women to

terminate their pregnancies unnecessarily.

Dr. us, director of the Institute of Reproductive Toxicology at

the University of Ulm, Germany, told a news briefing: " Our results

show the importance of a reliable pharmaco-vigilance system

documenting foetal outcome after medication in pregnancy. We need

international networks of registries to do this, but financial

support for this purpose is lacking. We hope for more serious efforts

from the pharmaceutical industry and governmental authorities in

Europe. We think that this is also an ethical challenge because many

patients opt for termination of pregnancy due to fear of congenital

malformations.

The FDA warning about the drug, which is a selective serotonin

reuptake inhibitor (SSRI), was issued on the basis of unpublished

research. " It showed that the absolute rate of major congenital

malformations seen in the first trimester for paroxetine® users

(PAXIL) was 4%, and 2% for cardiovascular malformations. Yet the

retrospective study of 5,956 women by the producer, GlaxoKline,

had only 591 cases of medication with paroxetine® during the first

trimester and did not include controls of women not taking an

antidepressant, " he said.*

In contrast, the research carried out by Dr us and his colleagues

was a prospective follow-up study that collected data on pregnancy

outcomes after medication with paroxetine® in 119 women between 1990

and 2005. " Our national Teratology Information Service (TIS) was

contacted by physicians and patients after exposure to paroxetine® in

the first trimester of pregnancy. We compared the results with a

control group of 645 women over the same period of time, who had not

been exposed, or not severely exposed, to the drug.

" We found that the rate of congenital abnormalities was not increased

after using paroxetine® in early pregnancy. Three abnormalities were

reported after exposure to paroxetine®: club feet after exposure

throughout pregnancy, a large port wine mark after exposure up to the

seventh week, and spastic torticollis (painful spasms of the neck

muscles) after exposure in the first twelve weeks. However, in the

non-paroxetine® group there was a similar rate of abnormalities, with

25 out of 557 babies affected. "

However, the researchers did find that the number of women deciding

to terminate their pregnancies was much higher amongst the paroxetine

group. " Eighteen out of 119 paroxetine users (just over 15%)

preferred termination of pregnancy compared to 17 out of 645 women in

the control group (2.6%). In most cases the patients opted for

termination of pregnancy because of a combination of reasons: partly

because of their depression, but also because of confusion caused by

information on possible damage to the foetus from the package

labelling.

" Our prospective controlled follow-up study does not support the

assumption that paroxetine® can cause congenital abnormalities.

Although our study of 119 paroxetine users was relatively small,

there are three other, peer-reviewed, published studies that show no

increased rates of cardiovascular malformations with paroxetine®,

whereas there has been no published research that shows that

paroxetine can cause abnormalities. We continue collecting data as a

member of the European Network of Teratology Services (ENTIS) in

order to reassure patients who need a long-term antidepressant

medication. "

Dr us highlighted the damage that incomplete research can have

not only on the unborn babies, through decisions to terminate

pregnancies, but also on the mental and physical well-being of

mothers, through not treating their depression or stopping their

medication abruptly.

" Depression, anxiety, obsessive-compulsive disorder and premenstrual

stress are common disorders during child-bearing years and can be

treated with antidepressants such as paroxetine®. Failure to treat

depression during pregnancy can have significant negative

ramifications for both mother and child. 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. If a woman does decide,

following a discussion with her physician, that she wants to

discontinue paroxetine®, the drug should be slowly tapered off. "