Intended for healthcare professionals

CCBYNC Open access

Rapid response to:


Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study

BMJ 2009; 339 doi: (Published 23 September 2009) Cite this as: BMJ 2009;339:b3569

Rapid Response:

Dr Mangin this study was not about paroxetine

To Dr Mangin,

You appear to be using this forum to state your opinions about
paroxetine in
pregnancy, which is understandable as you are a witness for the plaintiff
the GSK/Paxil lawsuiit. However, this study was not about paroxetine per
it was about SSRI's in general and DID NOT find an increase risk for heart

defects associated with the use of paroxetine in pregnancy, which as I
in my previous response was pretty much ignored. I would suggest that if
are going to make a statement, you should quote all the evidence-based
research, not only data that supports your agenda. You neglected to
several large studies that have been published recently, that did not
find an
increase risk. My own study with a comparison group which included 1170
women exposed and unexposed found the rates of heart defects the same in
each group.(1) Other groups also did not find an increased risk which also

were not mentioned.(2,3)

Understandably, due to the nature of this research, and the conflicting
of the studies, individuals do have strong opinions. However, we must
in mind that the reason this research is conducted is to assist women and
their health care providere in making the right choices for the mother and

unborn fetus and this should be made with evidence-based information, not


1) Einarson A, Pistelli A, DeSantis M, Malm H, Paulus WE, Panchaud A,
Kennedy D, Einarson TR, Koren G. Evaluation of the risk of congenital
cardiovascular defects associated with use of paroxetine during pregnancy.

Am J Psychiatry. 2008 Jun;165(6):749-52

2) Risks of congenital malformations and perinatal events among infants
exposed to antidepressant medications during pregnancy.Davis RL,
Rubanowice D, McPhillips H, Raebel MA, Andrade SE, Smith D, Yood MU, Platt

R; HMO Research Network Center for Education, Research in Therapeutics.
Pharmacoepidemiol Drug Saf. 2007 Oct;16(10):1086-94

3) Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective
serotonin reuptake inhibitors in pregnancy. Obstet Gynecol 2005; 106:1289-96.

Competing interests:
None declared

Competing interests: No competing interests

01 October 2009
Adrienne Einarson
Assistant Director, The Motherisk Program.
The Hospital for Sick Children, Toronto, Ontario. Canada, M5G 1X8