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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  07/26/2013
 
Trade Name:  Symbyax
 
Generic Name or Proper Name (*):  olanzapine and fluoxetine hydrochloride
 
Indications Studied:  Treatment of depressive episodes associated with bipolar I disorder
 
Label Changes Summary:  "*Expanded the indication from adults to pediatric patient 10-17 years *Safety and efficacy for treatment resistant depression in patients < 18 years have not been established *Symbyax is not approved for any indication in patients < 10 years *In a placebo-controlled clinical trial in patients 10 to 17 years, somnolence-related adverse events were commonly reported with drug treatment occurring in 23.5% of drug-treated patients compared with 2.4% of placebo-treated patients *The types of adverse reactions observed with olanzapine and fluoxetine hydrochloride in children and adolescents were similar to adult but the magnitude and frequency of some changes were greater in children and adolescents than adults. These included increases in lipids, hepatic enzymes, and prolactin, and increases in the QT interval. The frequency of weight gain greater than or equal to 7%, and the magnitude and frequency of increases in lipids, hepatic analytes, and prolactin in children and adolescents treated with olanzapine and fluoxetine hydrochloride were similar to those observed in adolescents treated with olanzapine monotherapy *Overall, 14.1% of the 170 patients in the olanzapine and fluoxetine hydrochloride group discontinued due to adverse reactions compared with 5.9% of the 85 patients for placebo. Adverse reactions leading to discontinuation associated with the use of olanzapine and fluoxetine hydrochloride were weight increased (2.9%), suicidal ideation (1.8%), bipolar disorder (1.2%), and somnolence (1.2%) versus placebo patients which had 0% incidence of weight increased, bipolar disorder, and somnolence, and a 1.2% incidence of suicidal ideation *Information on dosing, clinical trial, and adverse reactions
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Lilly
 
Therapeutic Category:  Antidepressant
 
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