There are potential risks to babies born to women who took antipsychotic drugs in pregnancy, Health Canada says.

The department said it is updating safety information on the drug labels to highlight the potential risk of abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with the drugs during the third trimester. 


Babies born to women treated with antipsychotic drugs during the third trimester run the risk of abnormal muscle movements and withdrawal symptoms, Health Canada says. (Michaela Rehle/Reuters)

Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

Health Canada said it has notified Canadian manufacturers of typical and newer antipsychotic drugs to update safety labels.

"Women taking an antipsychotic and who are pregnant or thinking of becoming pregnant should talk to their doctor about their treatment," Health Canada advised in a statement Wednesday.

"Patients should not stop taking their medication without first speaking to a healthcare practitioner, as abruptly stopping an antipsychotic drug can cause serious adverse events."

The potential problems in newborns include abnormal muscle movements and withdrawal symptoms such as:

  • Agitation.
  • Abnormally increased or decreased muscle tone.
  • Tremor.
  • Sleepiness.
  • Severe difficulty breathing.
  • Difficulty in feeding.

The symptoms can vary in seriousness. Some newborns may only experience these symptoms for hours or days and may not need treatment, while in others the symptoms may be more severe and need medical attention.

Health Canada's online drug product database lists hundreds of antipsychotic medications, both brand and generic names, in different strengths, formulations and routes of administrations.

The medications include risperidone, clozapine, quetiapine, methotrimeprazine, rifluoperazine, loxapine, olanzapine, perphenazine and haloperidol and their brand-name equivalents.

Consumers may report any adverse reaction potentially related to these products to Health Canada at  1-866-234-2345 or by visiting its MedEffect website.