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U.S. Department of Health and Human Services

Safety

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Symbyax (olanzapine and fluoxetine hydrochloride) capsule

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

 

Summary View

 

WARNINGS and PRECAUTIONS

Hyperprolactinemia (study information reworded and updated)
  • In controlled clinical studies of Symbyax (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 28% of adults treated with Symbyax as compared to 5% of placebo-treated patients. Modest elevations persisted throughout administration of SYMBYAX. In a pooled analysis from clinical studies including 2929 adults treated with Symbyax, potentially associated clinical manifestations included menstrual-related events1 (1% [20/1946] of females), sexual function-related events (7% [192/2929] of females and males), and breast-related events (0.8% [16/1946] of females, 0.2% [2/983] of males).
  • In placebo-controlled olanzapine clinical studies (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 30% of adults treated with olanzapine as compared to 10.5% of adults treated with placebo. In a pooled analysis from clinical studies including 8136 adults treated with olanzapine, potentially associated clinical manifestations included menstrual related events (2% [49/3240] of females), sexual function-related events (2% [150/8136] of females and males), and breast-related events (0.7% [23/3240] of females, 0.2% [9/4896] of males).
  • In placebo-controlled olanzapine monotherapy studies in adolescent patients (up to 6 weeks) with schizophrenia or bipolar I disorder (manic or mixed episodes), changes from normal to high in prolactin concentrations were observed in 47% of olanzapine treated patients compared to 7% of placebo-treated patients. In a pooled analysis from clinical trials including 454 adolescents treated with olanzapine, potentially associated clinical manifestations included menstrual-related events1 (1% [2/168] of females), sexual function-related events (0.7% [3/454] of females and males), and breast-related events3 (2% [3/168] of females, 2% [7/286] of males)

ADVERSE REACTIONS

Vital Signs and Laboratory Studies
  • An increase in creatine phosphokinase has been reported very rarely in Symbyax-treated patients and infrequently in clinical trials of olanzapine-treated patients.