FDA MedWatch- Antipsychotics Class Label Change

FYI

A Catalyst for Debate www.ahrp.org FDA MedWatch- Antipsychotics Class Label Change FYI The FDA has just issued an alert to healthcare professionals--in particular psychiatrists and obstetricians-- disclosing the serious risks antipsychotic drugs pose for newborn infants. "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." The new warning is in addition to the long list of warnings about these toxic drugs--including a Black Box warning about the increased risk of death linked to antipsychotics. Yet, instead of protecting newborns and pregnant women, by contraindicating the prescribing of these extremely toxic drugs for women who may become pregnant, the FDA recommends that pregnant women should keep taking the drugs: " 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." What on earth are FDA officials thinking? Read: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma... icalProducts/ucm244175.htm 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 Contact: Vera Hassner Sharav [email protected]