Paroxetine is associated with malformation during pregnancyBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5060 (Published 10 August 2011) Cite this as: BMJ 2011;343:d5060
- Derelie Mangin, associate professor1,
- David Healy, professor2,
- Barbara Mintzes, assistant professor3
- 1Department of Public Health and General Practice Christchurch, University of Otago, New Zealand
- 2North Wales Department of Psychological Medicine, Cardiff University, UK
- 3Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada V6T 1Z3
In their clinical review of the diagnosis and management of premenstrual disorders O’Brien and colleagues state1: “Obviously, some patients may become pregnant while taking SSRIs [selective serotonin reuptake inhibitors] and these drugs have not been shown to be teratogenic” with a reference to an article reviewing the adverse effects of SSRIs in pregnancy.2 This is incorrect and is inconsistent not only with the reference provided but also with both the label (black box warning and the pregnancy category D labelling) and the wider literature. Tuccori et al in fact state:
“Paroxetine has been associated with significant risks of major malformation, particularly cardiac defects, when used during pregnancy.
“Significant associations between maternal exposure to SSRIs and both persistent pulmonary hypertension of the newborn and a self-limiting neonatal behavioral syndrome have been reported in a number of recent original studies and meta-analyses.”2
They correctly conclude: “The available evidence suggests that SSRIs and other serotonergic/noradrenergic antidepressants should be used with caution during pregnancy, with careful follow-up of infants exposed to these agents in utero.”
Evidence shows SSRIs to be teratogenic in early pregnancy.3 Concerns about the effects on child development are emerging with a recent signal of a potential link with autistic spectrum disorder.4 5 This is important information for clinicians and patients to be aware of when use is in women of reproductive age. Women need to be warned of these potential adverse events when these medicines are prescribed.
Cite this as: BMJ 2011;343:d5060
A correction is published at www.bmj.com/content/343/bmj.d5032
Competing interests: DM and DH are expert witnesses for the plaintiff in cases involving Paxil and birth defects in the US. DM is also principal investigator in a New Zealand HRC funded randomised controlled trial of SSRI cessation in primary care. She is a member of the New Zealand Pharmaceutical and Therapeutic Products Advisory Committee.