Safety Alerts & Recalls

What does this mean?

Antipsychotic medications are effective in treating psychiatric disorders and other mood and behavior conditions. If you are taking an antipsychotic medication, you should continue to take your medication as directed by your doctor.

If you are a woman of childbearing age, please notify your healthcare professional if you become pregnant or plan to become pregnant while taking an antipsychotic medication. You should not stop taking these medications if you become pregnant without first talking to your healthcare professional, as abruptly stopping antipsychotic medications may cause side effects and can have a negative impact on the outcome of pregnancy. Talk to your healthcare professional if you have concerns about your condition and any treatment you are receiving during pregnancy.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these medicines to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Labeling Change for all Antipsychotic Medications: Warnings Regarding Use During Pregnancy

The U.S. Food and Drug Administration (FDA) notified healthcare professionals that the Pregnancy section of the drug labels for the entire class of antipsychotic medications has been updated to contain more 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 improve within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

Antipsychotic medications are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder, and have been shown to improve daily functioning in individuals with these disorders. Common brand names for antipsychotic medications include Haldol, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, and Invega.

To see a complete list of antipsychotic medications, please visit: more information here

For more information about this safety alert, please visit: more information here

Source: FDA
Publication Date: 2011-02-22
Last Updated: 2011-02-23
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