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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:  12/08/2005
 
Trade Name:  Meridia
 
Generic Name or Proper Name (*):  sibutramine
 
Indications Studied:  Obesity
 
Label Changes Summary:  * The data are inadequate to recommend the use of sibutramine for the treatment of obesity in pediatric patients * Efficacy in obese adolescents has not been adequately studied * Sibutramine's mechanism of action inhibiting the reuptake of serotonin and norepinephrine is similar to that of some antidepressants * It is unknown if sibutramine increases the risk of suicidal behavior or thinking in pediatric patients * In a study of adolescents with obesity in which 368 patients were treated with sibutramine and 130 patients with placebo, one patient in each group attempted suicide. Suicidal ideation was reported by 2 sibutramine-treated patients and none of the placebo patients
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Abbott
 
Pediatric Exclusivity Granted Date:  10/06/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Obesity management
 
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