Neuroscience
An FDA press release from yesterday:
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents
The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.
Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.
“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”
The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.
The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.
Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.
Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.
For more information:
FDA Office of Pediatric Therapeutics
link
National Institute of Mental Health—Schizophrenia
link
National Institute of Mental Health—Bipolar Disorder
link
- No Schizophrenia?
2 NAMES, 1 DISEASE: Does schizophrenia=psychotic bipolar disorder? in Current Psychiatry suggests that schizophrenia is actually severe bipolar I psychosis and not a separate diagnosis. A comprehensive review references questions going back many years,...
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Neuroscience
Risperdal (risperidone) and Pediatric Schizophrenia and Bipolar DIsorder
An FDA press release from yesterday:
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents
The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.
Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.
“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”
The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.
The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.
Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.
Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.
For more information:
FDA Office of Pediatric Therapeutics
link
National Institute of Mental Health—Schizophrenia
link
National Institute of Mental Health—Bipolar Disorder
link
- No Schizophrenia?
2 NAMES, 1 DISEASE: Does schizophrenia=psychotic bipolar disorder? in Current Psychiatry suggests that schizophrenia is actually severe bipolar I psychosis and not a separate diagnosis. A comprehensive review references questions going back many years,...
- Fda: Lundbeck's Sabril (vigabatrin) And Infantile Spasms
From a press release by the FDA: Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Fda: Alzheimer Disease, Aricept (donepezil Hydrochloride)
From the FDA last week: FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease FOR IMMEDIATE RELEASE P06-168 October 13, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA...
- Fda Says 'no' To Risperdal (risperidone) As A Treatment For Psychotic Symptoms In Alzheimer Disease
Johnson & Johnson released information earlier today that the Food and Drug Administration did not approve its antipsychotic medication Risperdal (risperidone) for use as a treatment for psychotic symptoms in Alzheimer disease. Full U.S. prescribing information...