FDA Approves Risperdal to Treat Adolescents with Schizophrenia andChildren and Adolescents with Bipolar Mania
TITUSVILLE, N.J., August 22, 2007 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents ages 13-17 and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.
This approval is based on studies involving more than 430 adolescents, ages 13-17, in the treatment of schizophrenia and 160 children and adolescents, ages 10-17, for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder.
Risperdal is marketed in the U.S. by Janssen, L.P. and promoted by McNeil Pediatrics, a division of McNeil-PPC., Inc.
Janssen is the only U.S. pharmaceutical company exclusively dedicated to mental health. For more information about Risperdal, visit http://www.janssen.com.
Risperdal (risperidone) is indicated in adults for the treatment of schizophrenia, for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, for the treatment of irritability associated with autistic disorder in ages 5-16 years, for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10-17 years.
Important Safety Information For Risperdal
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Risperdal (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.
The most common adverse reactions observed in all clinical trials with Risperdal occurring at a rate of at least 10% were: somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.
A rare but serious side effect that has been reported with this kind of medicine, including Risperdal, is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.
You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your health care professional.
Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including Risperdal. Some people may need regular blood sugar testing.
Some people taking Risperdal may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your health care professional's dosing instructions, this side effect may be reduced or it may go away over time.
You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors and muscle stiffness. Some people taking Risperdal have these side effects. If you have these symptoms, talk to your health care professional.
Some medications may interact with Risperdal. Avoid alcohol while on Risperdal.
Inform your health care professional if you are pregnant or if you are planning to get pregnant while taking Risperdal. Do not breastfeed if you are taking Risperdal.
Risperdal may affect your driving ability, therefore, do not drive or operate machines before talking to your health care professional.
Risperdal may affect alertness and motor skills; use caution until the effect of Risperdal is known.
Please see full important U.S. prescribing information for Risperdal at http://www.janssen.com.
Janssen, L.P., based in Titusville, NJ, is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania and irritability associated with autistic disorder. For more information about Janssen, L.P., visit http://www.janssen.com.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C., is headquartered in Raritan, NJ, and has facilities throughout Europe and the U.S. The company is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
CONTACT: Media, Ambre Morley, +1-609-730-3429, or ;Investors, Louise Mehrotra, +1-732-524-6491, Stan Panasewicz,+1-732-524-2524, Lesley Fishman, +1-732-524-3922, all of Johnson & Johnsonfor Janssen, L.P. firstname.lastname@example.org
Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: August 2007
- FDA Grants Approval for Use of Risperdal Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder - May 18, 2009
- FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder - February 11, 2009
- FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment - October 10, 2008
- Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder - July 24, 2008
- Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder - April 14, 2008
- FDA Issues Approvable Letter for Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania - June 21, 2007
- FDA Approves New Dose of Risperdal Consta for SchizophreniaTreatment - April 13, 2007
- FDA Approves Risperdal to Treat Irritability Associated with Autism - October 6, 2006
- Risperdal Consta Approved for Schizophrenia - October 29, 2003
- Risperdal Approved for Schizophrenia, Bipolar Mania - December 29, 1993
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.