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expert reaction to antidepressant paroxetine and birth defects

Publishing in the British Journal of Clinical Pharmacology a group of scientists have investigated the effects of taking a specific antidepressant while pregnant on birth defects. In the meta-analysis they report that using paroxetine in the first trimester of pregnancy was associated with an increased risk of cardiac-specific as well as general birth defects.


Dr Patrick O’Brien, spokesperson for the Royal College of Obstetricians and Gynaecologists (RCOG) said:

“This new analysis of previously published data confirms that, while the absolute risk remains very low, use of Paxil (paroxetine) in the first three months of pregnancy appears to be associated with a small increased risk of birth defects.

“Depression in pregnancy can be very serious for a woman and can also impact on the health of her baby, so it is important to consider the benefits of antidepressant medication in such cases. Our advice for pregnant women suffering with depression would be that generally the benefits outweigh the risks. However, all pros and cons should be discussed and weighed up by a woman, together with her obstetrician.”


Dr Michael Bloomfield, Clinical Lecturer in Psychiatry, MRC Clinical Sciences Centre and UCL, said:

“Whilst depression during and following pregnancy is very common, it can be a potentially devastating and life-threatening illness, both to the mother and her infant. This new study adds to existing evidence regarding the safety of antidepressant medicines in pregnancy. Clinical decisions regarding whether or not to treat depression in pregnancy are made by balancing the potential risks of an untreated illness with the potential small risks of treatment. Owing to existing concerns about the safety of paroxetine in pregnancy it is not currently recommended as the first line treatment for depression.

“Nonetheless, it remains unknown whether the risks identified in this study are attributable to the treatment. Larger scientific studies need to be carried out on this important topic to tease out many potential confounding factors in this research relating to cause and effect. Further research is therefore needed to provide more accurate information for doctors to guide their patients on these important decisions.

“More pressing, however, is the need to increase investment in perinatal psychiatric services to enable mothers to have access to expert psychiatric care – which can include medicines alongside talking therapies, given that psychiatric problems account for leading causes of death and illness.

No one should stop taking a medicine without discussing this with their doctor first.  Anyone who is concerned about the risks of taking an antidepressant during pregnancy should discuss this with their general practitioner or psychiatrist.”


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

“This paper addresses an important issue for many women who face difficult decisions about starting or continuing antidepressant medication in pregnancy.

“There is no new data here – rather the evidence from existing studies have been put together and the results, unsurprisingly, are consistent with findings over the last decade that have found an association between exposure to antidepressant medication in pregnancy and malformations. However, the cause of this relationship remains uncertain.

“It is possible that the higher risk of malformations 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. The baseline risk in the general population for malformations in children is around 3%. The studies to date have suggested that the rate of malformations in children born to women with mood disorders taking SSRIS in pregnancy may be slightly higher at around 3.25%. It is difficult to know whether this small increase in risk is due to the medication being taken, to the mood disorder itself, or to other factors associated with mood disorders and antidepressant medication.

“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. 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 and particularly for mild to moderate depression other approaches such as talking treatments would be better options. 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. 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.”


The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: A systematic review and meta-analysis’ by Bérard et al. published in the British Journal of Clinical Pharmacology on Tuesday 5th January. 


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


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