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Antidepressant drug linked with increased risk of birth defects when taken in early pregnancy

January 05, 2016

Using paroxetine--a medication prescribed to treat conditions including depression, obsessive-compulsive disorder, anxiety and posttraumatic stress disorder--during the first trimester of pregnancy may increase newborns' risk of congenital malformations and cardiac malformations. That's the conclusion of a recent analysis published in the British Journal of Clinical Pharmacology.

Up to one-fifth of women of childbearing age experience depressive symptoms that often lead to mild to moderate depression, and prescriptions for antidepressants during pregnancy have increased in recent years. The most common drugs for treating depression in pregnant women are selective serotonin reuptake inhibitors, and up until 2005, one drug in that class--paroxetine--was considered to be safe for use during pregnancy. A small unpublished study conducted by the manufacturer, however, suggested an increased risk of cardiac malformations in infants exposed to paroxetine before birth. Subsequent studies using various study designs in different populations across Europe and North America generated conflicting results in terms of statistical significance, although a trend remained towards an increased risk.

To provide a comprehensive assessment of the effects of paroxetine on newborns, a team led by Professor Anick Bérard, PhD, of CHU Sainte-Justine and the University of Montreal, conducted a literature review and meta-analysis of all relevant studies published from 1966 to 2015. The investigators uncovered 23 eligible studies.

Compared with no use of paroxetine, first trimester use of paroxetine was associated with a 23 percent increased risk of any major congenital malformations and a 28 percent increased risk of major cardiac malformations in newborns. The investigators noted that the baseline risk of major malformations is 3 percent and of cardiac malformations is 1 percent; however, any increase in risk is significant, especially when considering that the benefit of using selective serotonin reuptake inhibitors during pregnancy--when changes in metabolism cause the drugs to be cleared from the body at a faster rate--is debatable.

"Given that the benefits of antidepressants overall, and selective serotonin reuptake inhibitors including paroxetine specifically, during pregnancy is questionable at best, any increase in risk--small or large--is too high," said Dr. Bérard. "Indeed, the risk/benefit ratio suggests non-use in women with mild to moderately depressive symptoms, which is 85 percent of pregnant women with depressive symptoms. Therefore, planning of pregnancy is essential, and valid treatment options such as psychotherapy or exercise regimens are warranted in this special population."
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Full citation: "The risk of major cardiac malformations associated with paroxetine use in the first trimester of pregnancy: A systematic review and meta-analysis." Anick Bérard, Noha Iessa, Sonia Chaabane, Flory T. Muanda, Takoua Boukhris, and Jin-Ping Zhao. British Journal of Clinical Pharmacology. DOI: 10.1111/bcp.12849

URL Upon Publication: http://doi.wiley.com/10.1111/bcp.12849

Author Contact:

To arrange an interview with the author, please contact William Raillant-Clark at w.raillant-clark@umontreal.ca or marise.daigle@recherche-ste-justine.qc.ca.

About the Journal

The British Journal of Clinical Pharmacology has the primary goal of publishing high quality research papers on all aspects of drug action in humans. The journal has a wide readership, bridging the medical profession, clinical research and the pharmaceutical industry, and is published monthly. It is owned by the British Pharmacological Society and published by Wiley-Blackwell. The journal's 2013 Impact Factor is 3.688, its highest ever (Thomson Reuters Science Citation Index).

About The British Pharmacological Society

The British Pharmacological Society is the primary UK learned society concerned with research into drugs and the way they work. With over 3,500 members from over 60 countries worldwide, it is also a truly international organization. The Society covers the whole spectrum of pharmacology, including laboratory, clinical, and toxicological aspects and supports its members at work in academia, industry, regulatory agencies and the health service. It promotes the interests of pharmacologists through scientific meetings, educational materials and learned journals: the British Journal of Clinical Pharmacology, Pharmacology Research & Perspectives, and the British Journal of Pharmacology, which includes the Concise Guide to PHARMACOLOGY, featuring open access overviews of the key properties of over 2,000 targets with pharmacology and links to http://www.guidetopharmacology.org.

Press Office: +44 20 7239 0180 | M. +44 7786 552498 | E. sophia.griffiths@bps.ac.uk

About Wiley

Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content. The Company's website can be accessed at http://www.wiley.com.

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