Product Liability

Class of antipsychotics now includes warning about use during pregnancy

A class of antipsychotic medications has a newly updated safety label that includes a warning for pregnant women and women of childbearing age to avoid use of the drugs because of a risk of extrapyramidal symptoms (EPS) and withdrawal symptoms in newborn babies, according to the Food and Drug Administration (FDA) monthly safety labeling updates report. Extrapyramidal symptoms include a variety of movement disorders such as those that cause the inability to initiate movement and the inability to remain motionless.

The new warning labels stress that the products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in newborn babies whose mothers used this class of antipsychotics during pregnancy. The complications have varied in severity. In some cases, symptoms have been self-limited, in other cases, newborns have required intensive care unit support and prolonged hospitalization.

Brand-name medications that will receive the new warning include:

  • Abilify (aripiprazole) tablet, oral solution, orally disintegrating tablet, and injectable formulation
  • Clozaril (clozapine) tablets
  • Fanapt (iloperidone) tablets
  • Fazaclo (clozapine) orally disintegrating tablets
  • Geodon (ziprasidone HCl) capsules, oral suspension and Geodon (ziprasidone mesylate) injection
  • Haldol (haloperidol) injection and Haldol Decanoate IM injection
  • Invega (paliperidone) extended-release tablets Invega Sustenna (paliperidone) intramuscular injection
  • Moban (molindone HCL) tablets
  • Navane (thiothixene) capsules
  • Orap (pimozide) tablets Risperidone tablets, rapidly disintegrating tablets, solution, and longacting injection
  • Saphris (asenapine) sublingual tablets
  • Seroquel (quetiapine fumarate) tablets and Seroquel XR (quetiapine fumarate) extended release tablets
  • Symbyax (olanzapine and fluoxetine HCL) capsules
  • Zyprexa (olanzapine) tablets, Zyprexa Zydis orally disintegrating tablets and IM injection
  • Zyprexa Relprevv (olanzapine) for extended release injectable suspension

Any side effects with these or any other medications should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.