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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:
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
BPCA(B):
B
Sponsor:
Hoffman La-Roche
Pediatric Exclusivity Granted Date:
06/12/2001
NNPS:
FALSE'
Therapeutic Category:
Antiacne
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