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expert reaction to fluoxetine and birth defects

Publishing in the British Journal of Pharmacology scientists report an association between slightly increased risk of cardiovascular malformations in infants and maternal fluoxetine use.


Prof. Allan Young, Professor of Mood Disorders and Director, Centre for Affective Disorders, King’s College London’s Institute of Psychiatry, Psychology and Neuroscience, said:

“This paper raises the possibility of some increased birth defects in children of mothers who took fluoxetine whilst pregnant.

“The authors themselves note “our study was not able to draw definitive conclusions whether fluoxetine specifically could contribute to the increased risk as opposed to depression itself.”

“These findings should be borne in mind when doctors prescribe to depressed (potentially) pregnant women and balance the risks of benefits and harms of treatment.  It should also always be remembered that untreated depression may have serious consequences for the mother and the child.”


Prof. Ian Jones, Professor of Psychiatry and Director of National Centre for Mental Health, Cardiff University, said:

“The paper is consistent with other studies published in recent years that have found an association between exposure to SSRI medication in pregnancy and a higher risk of malformations in children. However, the cause of this relationship remains uncertain. It is possible that the higher risk is due to the medication, but it may also be due to the effects of the mood disorder for which the medication has been prescribed or other factors known to be associated with malformations (such as diet, drug and alcohol use) that may be more common in women taking these drugs. A number of studies of antidepressants in pregnancy have found that the better they control for these confounding factors, the smaller the impact of the medication itself.

“Although it is still difficult to know for definite whether antidepressant medication increases the risk of malformations in children, what we can be certain of is that any increase is not large. Depression in pregnancy and following childbirth (the postpartum period) is common, and is an illness with potentially serious consequences. It can be severe, with serious implications for the woman, her baby and her wider relationships. We must always remember that suicide is a leading cause of maternal death in the UK.

“Women should not be taking medication in pregnancy if they don’t need to. For a woman taking an antidepressant and who is considering starting a family, or finds that she is pregnant, this is an excellent time to consider whether the medication is still required. Women should not stop their medication suddenly and, if they are concerned about continuing the antidepressant in pregnancy, they should discuss the options with their doctor.

“For some women, episodes of depression may be mild and brief, while in others they may be very severe and long lasting. A range of different treatment approaches may help women with depression and may include improved support, specific psychological and social interventions and for some women treatment with medication. In general the National Institute for Health and Care Excellence (NICE) only recommends antidepressant treatment for people with moderate to severe episodes of depression. It is vital that women who become depressed in pregnancy can access appropriate and timely help. For some women with moderate to severe episodes of depression, or with a history of severe mental illness, taking medication in pregnancy may be the most appropriate decision.

“The decision to take medication in pregnancy is always difficult. It must be made by women themselves, following discussion with their doctors where they weigh up the risks and benefits of all options, taking into account their individual needs and circumstances. It is important to recognise that severe psychiatric illness may have negative consequences for the woman, her baby and her family, and these must be weighed against what is known about the risks of taking medication.

“Antidepressants definitely have their place. Not only is suicide a major risk, but if a woman has an episode of depression it can have profound implications for the mother, baby and the whole family. There may be risks with taking antidepressants, as with other medications, but there are also significant risks from not receiving treatment and women who are concerned should discuss the balance of benefit and risk with their doctor.”


* ‘Fluoxetine and congenital malformations: a systematic review and meta-analysis of cohort studies’ by Gao et al. published in the British Journal of Clinical Pharmacology on Wednesday 17th May.


All our previous output on this subject can be seen at this weblink:


Declared interests

Prof. Young: “Receipt of grants/research supports: Investigator initiated studies from AZ, Eli Lilly and Lundbeck. Receipt of honoraria or consultation fees:  Paid lectures and advisory boards for all major pharmaceutical companies with drugs used in affective and related disorders.”

Prof. Jones: “no conflicts of interest”

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