Antipsychotic drug labels will bear an updated warning to pregnant women about the potential risk for abnormal muscle movements and withdrawal symptoms in neonates, the US Food and Drug Administration (FDA) announced today.
More than 20 antipsychotic drugs affected by today’s action include such well-known agents as risperidone (Risperdal, Ortho-McNeil-Janssen Pharmaceuticals), aripiprazole (Abilify, Otsuka America Pharmaceutical), haloperidol (Haldol, Ortho-McNeil-Janssen Pharmaceuticals), and clozapine (Clorazil).
The new drug labels will spell out in more detail and consistency the potential risk for extrapyramidal signs (EPS) and withdrawal symptoms for newborns whose mothers took these placenta-crossing medications during the third trimester of pregnancy.
The FDA uncovered 69 cases of neonatal EPS or withdrawal associated with antipsychotic drugs through October 29, 2008, in a search of the agency’s Adverse Event Reporting System (AERS) database. Symptoms included hypotonia, hypertonia, somnolence, tremor, respiratory distress, and feeding disorder. Most of the 69 cases involved confounding factors, such as the concomitant use of other psychoactive drugs, prematurity, and obstetric complications. “However, there were some cases which suggest that neonatal EPS and withdrawal may occur with antipsychotics alone,” the agency stated.
The FDA is advising clinicians to monitor neonates displaying EPS or withdrawal symptoms, noting that while some recover within hours or days, others may require prolonged hospitalization.
The drugs that will bear an updated warning about the risks of EPS and withdrawal are as follows:
clozapine (Clozaril; FazaClo ODT)
paliperidone (Invega; Invega Sustenna)
risperidone (Risperdal; Risperdal Consta)
quetiapine (Seroquel; Seroquel XR)
olanzapine (Zyprexa; Zyprexa Relprevv; Zyprexa Zydis)
olanzapine and fluoxetine (Symbyax)
perphenazine and amitriptyline
More information about today’s announcement is available on the FDA Website.
To report adverse events related to antipsychotic drugs, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Reported by Robert Lowes
Medscape Medical News