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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:  05/05/2004
Trade Name:  Effexor and Effexor XR
Generic Name or Proper Name (*):  venlafaxine
Indications Studied:  Major Depressive Disorder
Label Changes Summary:  * Effectiveness in pediatric patients has not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. * 18% of Effexor XR treated patients (6-17 years) versus 3.6 % of placebo treated patients experienced a weight loss of at least 3.5 % in both MDD and the GAD studies * In an open-label study increases in weight were less than expected based on data from age and sex matched peers. The difference between observed weight gain was larger for children less than 12 years than for adolescents older than 12 years * During an 8 week placebo controlled GAD trial, Effexor XR treated patients ages 6-17 years grew an average of 0.3 cm, while placebo treated patients grew an average of 1 cm. In a 6 month open-label study, height increases that were less than expected based on data from age and sex matched pairs. The difference between observed and expected growth rates were larger for children less than 12 years than for adolescents older than 12 years * Decreased appetite observed in 10% of patients ages 6-17 years old receiving Effexor XR * Occurrence of blood pressure and cholesterol increases considered clinically relevant in pediatric patients similar to that observed in adults
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Wyeth
Pediatric Exclusivity Granted Date:  12/02/2002
Therapeutic Category:  Antidepressant