MedWatch - The FDA Safety Information and Adverse
Event Reporting Program
GlaxoSmithKline (GSK) and FDA notified healthcare
professionals of changes
to the Pregnancy/PRECAUTIONS section of the
Prescribing Information for
Paxil and Paxil CR Controlled-Release Tablets to
describe the results of a
GSK retrospective epidemiologic study of major
congenital malformations in
infants born to women taking antidepressants
during the first trimester of
pregnancy. This study suggested an increase in
the risk of overall major
congenital malformations for paroxetine as
compared to other antidepressants
[OR 2.2; 95% confidence interval, 1.34-3.63].
Healthcare professionals are
advised to carefully weigh the potential risks
and benefits of using
paroxetine therapy in women during pregnancy and
to discuss these findings
as well as treatment alternatives with their
patients.
Read the complete MedWatch 2005 Safety summary,
including links to the Dear
Healthcare Professional Letter and revised
labeling, at:
http://www.fda.gov/medwatch/safety/2005 ... htm#Paxil2--------
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