Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns

[Guest guest]

[Are people now supposed to feel safe and protected?  This is a joke. This issue with these (and other) psychotropic drugs was claimed over 20 years ago but mainstream medicine needed the FDA to say something about it (because they're incapable of critical thought), and the FDA needs scores of babies suffering (and tons of pressure) to do a mere label change. Nothing else changes, though. Because mainstream medicine knows no other way to work with a person experiencing psychosis, doctors will tell women there is no choice but to take the drugs and have babies born with brain damage (EPS) and a physiological dependency on these drugs.

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Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns

including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax

AUDIENCE: Psychiatry, OBGYNISSUE: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1- to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm