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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:  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
Sponsor:  Hoffman La-Roche
Pediatric Exclusivity Granted Date:  06/12/2001
Therapeutic Category:  Antiacne