A study carried out by German researchers has failed to show that a popular antidepressant, paroxetine, causes congenital abnormalities if taken by pregnant women.
This study was presented today [June, 19/06] at the 22nd annual conference of the European Society of Human Reproduction and Embryology.
Dr Wolfgang Paulus 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 Paulus, 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The FDA warning about the drug, which is a selective serotonin reuptake inhibitor (SSRI), was issued on the basis of unpublished research.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 was 4%, and 2% for cardiovascular malformations. Yet the retrospective study of 5,956 women by the producer, GlaxoSmithKline, 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 Paulus 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.
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