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Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats at doses up to 40 mg/kg/dayThese doses correspond to 1 timesmiceand 2 timesratsthe maximum recommended human doseMRHDof 200 mg/day on a mg/m 2 basisThere was a dose-related increase of liver adenomas in male mice receiving sertraline at 10-40 mg/kg0.25-1.0 times the MRHD on a mg/m 2 basisNo increase was seen in female mice or in rats of either sex receiving the same treatmentsnor was there an increase in hepatocellular carcinomasLiver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humansThere was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg2 times the MRHD on a mg/m 2 basisthis was not accompanied by thyroid hyperplasiaWhile there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10-40 mg/kg0.5-2.0 times the MRHD on a mg/m 2 basiscompared to placebo controlsthis effect was not clearly drug related.
FDA pregnancy category CTell your doctor right away if you become pregnant while taking this medicationSertraline may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancyHoweveryou may have a relapse of depression if you stop taking your antidepressantDo not start or stop taking sertraline during pregnancy without your doctor’s advice.
ZOLOFT has not been systematically evaluated in patients with seizure disordersPatients with a history of seizures were excluded from clinical studiesZOLOFT should be prescribed with caution in patients with a seizure disorder.
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