In February 2011, the US Food and Drug Administration (FDA) updated the Pregnancy section of drug labels for all medications included in the antipsychotic class of drugs. The new labels contain information about the risk of abnormal muscle movements and withdrawal symptoms in newborns whose mothers took the antipsychotic medications during the third trimester of pregnancy.
Antipsychotic Side Effects
According to the FDA, symptoms of the abnormal muscle movements (extrapyramidal signs or EPS) and symptoms of withdrawal in newborns can include agitation, abnormal muscle tone, tremors, sleepiness, difficulty breathing and difficulty feeding. Although the symptoms may subside in some newborns without treatment, other newborns may be required to stay in the hospital.
In making its announcement, the FDA cited information from the Adverse Event Reporting System (AERS), which identified 69 cases of EPS or withdrawal linked to antipsychotic medications. Because blood samples were not taken, the FDA could not determine if the newborns' side effects were caused by antipsychotic drug toxicity or withdrawal from antipsychotic medications. Symptoms appeared anywhere from birth to one month after birth.
Antipsychotic Drug Side Effects
In May 2011, Health Canada issued a warning about the risk of withdrawal symptoms and abnormal muscle movements in newborns who were exposed to antipsychotic drugs during the third trimester. The Canadian health authority said manufacturers of the antipsychotic medications were being told to update their safety labels. Among the potential issues Health Canada identified were agitation, abnormal muscle tone, tremors, sleepiness, difficulty breathing and difficulty feeding. Depending on the severity of the side effects, some infants may require medical attention.
Other side effects of antipsychotic medications include drowsiness, dizziness, blurred vision, rapid heartbeat and skin rashes.
Antipsychotic Medication Side Effects
Antipsychotic medications are used to treat the symptoms of psychiatric disorders, including schizophrenia and bipolar disorder. Some typical antipsychotic medications have been linked to an increased risk of tardive dyskinesia, according to the National Institute of Mental Health. Furthermore, some elderly people with dementia may be at a higher risk of death when taking atypical antipsychotic medications.
Among the antipsychotic medications are:
- Abilify (aripiprazole)
- Clozaril (clozapine)
- FazaClo ODT (clozapine)
- Fanapt (iloperidone)
- Geodon (ziprasidone)
- Haldol (haloperidol)
- Invega (paliperidone)
- Invega Sustenna (paliperidone)
- Loxitane (loxapine)
- Moban (molindone)
- Navane (thiothixene)
- Orap (pimozide)
- Risperdal (risperidone)
- Risperdal Consta (risperidone)
- Saphris (asenapine)
- Seroquel (quetiapine)
- Seroquel XR (quetiapine)
- Stelazine (trifluoperazine)
- Thorazine (chlorpromazine)
- Zyprexa (olanzapine)
- Zyprexa Relprevv (olanzapine)
- Zyprexa Zydis (olanzapine)
- Symbyax (olanzapine and fluoxetine)
- Fluphenazine (No Current Brand Name)
- Perphenazine (No Current Brand Name)
- perphenazine and amitriptyline (No Current Brand Name)
- prochlorperazine (No Current Brand Name)
- thioridazine (No Current Brand Name)
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Last updated on Jun-17-11