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:  05/02/2002
 
Trade Name:  Accutane
 
Generic Name or Proper Name (*):  isotretinoin
 
Indications Studied:  Severe recalcitrant nodular acne
 
Label Changes Summary:  Safety and effectiveness information on pediatric patients 12-17 years of age Identified an increased incidence of back pain, arthralgia and myalgia in pediatric patients New General Precautions subsection- caution when prescribing Accutane to pediatric patients with disorders of bone metabolism, such as osteoporosis and osteomalacia Adolescents who participate in sports with a repetitive impact may be at increased risk for bone related injuries In an open-label study of pediatric patients (n=217) given a single course of therapy, 16 (7.9%) had decreases in lumbar spine bone mineral density (BMD) >4% (adjusted for body mass index); 21 (10.6%) patients had decreases in total hip BMD >5% (adjusted for body mass index)
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Hoffman La-Roche
 
Pediatric Exclusivity Granted Date:  06/12/2001
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiacne
 
-
-