Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, August 12, 2008

Paroxetine and Deformed Children








Thanks to the anonymous 'tipster' for sending me recent files.


The basic message in this one was this:


The present findings are consistent with other recent results suggesting the possibility of a modestly increased occurrence of congenital malformations following first trimester exposure to paroxetine compared to ,other antidepressants.






Paroxetine in the first trimester and the prevalence of congenital malformations


J. Alexander Cole DSc, MPH1*,y, Sara A. Ephross PhD2,
Irene S. Cosmatos MS3 and Alexander M. Walker MD, DrPH1



1 i3 Drug Safety, Auburndale, MA, USA
2 GlaxoSmithKline, Research Triangle Park, NC, USA
3 GlaxoSmithKline, Philadelphia, PA, USA


SUMMARY



Purpose To refine a preliminary analysis identifying a possibly increased prevalence of malformations among infants born to women exposed to paroxetine in the first trimester.



Methods This study used data from UnitedHealthcare, a large U.S. insurer, using datasets originally for a study of bupropion in pregnancy. We identified women with a live-born delivery between January 1995 and September 2004. We classified women according to their first trimester mono- or mono/polytherapy exposure to paroxetine and other antidepressants. We confirmed malformation cases by medical record abstraction. We calculated the adjusted odds ratios (AORs) through logistic regression.



Conclusions These more detailed paroxetine findings confirm previous findings of analyses of these data among women exposed to all types of antidepressants. The present findings are consistent with other recent results suggesting the possibility of a modestly increased occurrence of congenital malformations following first trimester exposure to paroxetine compared to other antidepressants. Copyright # 2007 John Wiley & Sons, Ltd.




Fid



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