Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-