EXPERT REACTION: Prozac during pregnancy linked to birth defects

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The most commonly prescribed antidepressant, fluoxetine, sold under the trade names Prozac and Sarafem among others, has been linked to an increased risk of birth defects when used by pregnant women. Sixteen published studies about the use of the drug during pregnancy were analysed by researchers who concluded that it poses a significant risk to infant development. Babies exposed to fluoxetine during the first trimester had an 18 per cent increased risk of major malformations, and a 36 per cent increased risk of cardiovascular malformations.

Journal/conference: British Journal of Clinical Pharmacology


Media Release

From: Wiley-Blackwell From: British Journal of Clinical Pharmacology

Analysis Examines Safety of Antidepressant Use During Pregnancy

Use of fluoxetine—the most commonly prescribed antidepressant—during pregnancy is linked with a slightly increased risk of malformations in infants, according to a recent analysis of published studies.

In the analysis of 16 studies, infants exposed to fluoxetine during the first trimester had an 18% increased relative risk of major malformations and a 36% increased relative risk of cardiovascular malformations. There were no significant observations of other system-specific malformations in the nervous system, eye, urogenital system, digestive system, respiratory system, or musculoskeletal system.

The findings are published in the British Journal of Clinical Pharmacology.

Expert Reaction

These comments have been collated by the Science Media Centre to provide a variety of expert perspectives and reflect independent opinion on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.

Anne Buist is a Professor of Women's Mental Health at the University of Melbourne

The decision to remain on medication in pregnancy is seldom taken lightly. It is a balance of risks to the fetus and mother of medication and remaining well versus no medication and the risks of the illness.

There is now good evidence that the illness itself, besides being associated with poorer self care in pregnancy and of the infant and potential suicide and impact on relationships and employment, that children exposed to significant ongoing anxiety in pregnancy have higher cortisol levels at birth and this remains with them for a lifetime, a probable marker of altered stress response functioning which may make them more at risk of mental health problems.

The children whose mothers took medication and were well did not have higher cortisol in several studies. For women with serious illnesses, there is no risk-free option in pregnancy; of note there is no risk free option for any woman, as well women on no medication can have things go wrong.

It has been known for some time that there is a slight increased risk of malformations with fluoxetine and paroxetine exposure in pregnancy and for this reason they are not the most prescribed medication in women planning to get pregnant (and I doubt fluoxetine is the most popularly prescribed antidepressant in the childbearing age group). The risk is however still very low.

It should be noted, and which this study confirms, that confounding variables play a significant part in the risk, and managing those which can be managed for any individual woman, including keeping the dose as low as possible, will reduce the risk to the fetus eg the RR went down from 1.3 to 1.13 in those studies where alcohol was controlled for.

Women on antidepressants as a group, are much more likely than those not on them to be: overweight, have diabetes, smoke, use illicit drugs and multiple drugs and alcohol. Not all these were controlled for in these studies.

Last updated: 17 May 2017 4:58pm

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