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.
