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2011-06-16

Health Canada: Antipsycotic Prescription Information being Updated (Pregnancy)

The following is from HSW - it is NOT a recall, however it does say that antipsychotic prescribing information is being reviewed & updated, and it is certainly something to be aware of and follow if it pertains to you :-)


Event Hightlights
Health Canada is informing healthcare professionals and consumers that the prescribing information for the entire class of antipsychotic drugs is being updated. The updated labelling will contain safety 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 of their pregnancy.
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 (typical and atypical) to update the Product Monographs to include this safety information. See HSW Product Details tab for a list of the affected products.
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. These symptoms can vary in seriousness. In some newborns, the symptoms may go away within hours or days and not require specific treatment, while in others the symptoms may be more severe and require medical attention.
Recommended Actions:Women taking an antipsychotic and who are pregnant or thinking of becoming pregnant should talk to their doctor about their treatment. 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.

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