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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Abbott
Pediatric Exclusivity Granted Date:
10/06/2004
NNPS:
FALSE'
Therapeutic Category:
Obesity management
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