New Warnings for Risperdal - Autism

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Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab (risperidone) orally disintegrating tablets, and Risperdal Consta (risperidone) long-acting injection.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

September 2011

Summary View1

WARNINGS and PRECAUTIONS

Metabolic Changes

Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Weight Gain

Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

June 2011

Summary View2

ADVERSE DRUG REACTIONS

Commonly-Observed Adverse Reactions in Double-Blind, Placebo- Controlled Clinical Trials - Autistic Disorder

In another study with patients treated for irritability associated with autistic disorder, headache (6%), epistaxis (6%) and pyrexia (6%) were also observed in Risperdal-treated pediatric subjects.

Other Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone

Blood and Lymphatic System Disorders: neutropenia Nervous System Disorders: head titubation

Postmarketing Experience

blood cholesterol increased, blood triglycerides increased drug withdrawal syndrome neonatal, dysgeusia

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm262813.htm

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