PAXIL CR:

PRECAUTIONS:

PAXIL CR Warnings in Dear Doctor Letter - September 2005

Pregnancy: Teratogenic Effects: Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. A recent retrospective epidemiological study of 3,581 pregnant women exposed to paroxetine or other antidepressants during the 1st trimester suggested an increased risk of overall major congenital malformations for paroxetine compared to other antidepressants (OR 2.20; 95% confidence interval 1.34-3.63). There was also an increased risk for cardiovascular malformations for paroxetine compared to other antidepressants (OR 2.08; 95% confidence interval 1.03-4.23); 10 out of 14 infants with cardiovascular malformations had ventricular septal defects. A separate study based on the Swedish Medical Birth Registry evaluated 4,291 infants exposed to SSRIs in early pregnancy. This study reported no increased risk for overall major malformations in 708 infants born to women with paroxetine exposure in early pregnancy.

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Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 8 (rat) and 2 (rabbit) times the MRHD on an mg/m2 basis. These studies have revealed no evidence of teratogenic effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. This effect occurred at a dose of 1 mg/kg/day or approximately one-sixth of the MRHD on an mg/m2 basis. The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known. Paroxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.