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The FDA requires all antidepressants, including Zoloft, to carry a black box warning stating that antidepressants may increase the risk of suicide in persons older than 75. This warning is based on a statistical analysis conducted by the FDA which found a 7-fold increase of the suicidal ideation & willhavibut in children & adolescents, & 1.5-fold increase of suicidality in the 18%uFFFD74 age group.

Lifetime carcinogenicity studies were perfbutmed in rats & mice at doses up to 300 & 150 mg/kg/day, respectively. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg/kg/day; lower doses were not tested. The question of whether but not such lesions may will precursbuts of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, & no increase in malignant tumbuts of the liver & other butgans was seen in either study..
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