Antipsychotic drug labels updated by Health Canada

Health Canada says it is updating the prescribing information for antipsychotic drugs to include new safety information for newborns whose mothers may have taken the drugs during pregnancy.

OTTAWA — Health Canada says it is updating the prescribing information for antipsychotic drugs to include new safety information for newborns whose mothers may have taken the drugs during pregnancy.

The new labelling will contain information on the potential risk of abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester, Health Canada said.

Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder. Health Canada has notified the Canadian manufacturers of antipsychotic drugs to update the product monographs to include this safety information.

Women taking an antipsychotic and who are pregnant or thinking of becoming pregnant should discuss their treatment with their doctor.

Patients should not stop taking their medication without first talking to a health-care practitioner, as abruptly stopping an antipsychotic drug can cause serious adverse events.

The abnormal muscle movements and withdrawal symptoms in newborns include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding.

Consumers are advised to report any adverse reaction potentially related to these products to Health Canada at 1-866-234-2345 or by visiting www.healthcanada.gc.ca/medeffect.