Label Changes for:

Zyprexa Relprevv (olanzapine) for extended release injectable suspension

December 2010

Changes have been made to the PRECAUTIONS sections of the safety label.

  • 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

 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010

 

New safety information should be included in the labeling for antipsychotics: Risk of EPS and withdrawal syndrome in neonates, with the use of the class of antipsychotics by the mothers has been updated to the above labels

 

USE IN SPECIFIC POPULATIONS/Pregnancy

Non-teratogenic Effects
  • Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.
  • These products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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