Risperidone Solution for injection

Special Alerts:

[Posted 06/13/2011] ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.

The FDA determined that the factors contributing to the confusion between the two products include:

• Similarities of both the brand (proprietary) and generic (established) names
• Similarities of the container labels and carton packaging
• Illegible handwriting on prescriptions
• Overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.

BACKGROUND: Risperidone (Risperdal) is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autistic disorder. Ropinirole (Requip) is a dopamine agonist used in the treatment of Parkinson’s disease and Restless Legs Syndrome.

RECOMMENDATION: Healthcare Professionals are reminded to clearly print or spell out the medication name on prescriptions and make certain their patients know the name of their prescribed medication and their reason for taking it. For more information visit the FDA website at: [Web] and [Web].

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: [Web] and [Web].