Antipsychotic drugs: Labelling update regarding the risk of abnormal muscle movements and withdrawal symptoms in newborns exposed during pregnancy

Starting date:

June 15, 2011

Posting date:

June 15, 2011

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

New safety information, Product label update

Audience:

General Public, Healthcare Professionals

Identification number:

RA-110005136

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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 below for a list of antipsychotics in Canada.)

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.

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.

Antipsychotic drugs currently marketed in Canada

Antipsychotic drugs are available in multiple strengths and formulations, such as drops, liquid, tablets and capsules that are taken by mouth, as a powder or solution for injection, or in suppository format. They can be administered by healthcare professionals in a healthcare setting or taken by patients at home.

Below is a list of brand names of antipsychotic drugs, their generic equivalent and the active ingredient. Please note that there are hundreds of antipsychotic drugs currently sold in Canada. For simplicity, the table provides the drug names, but not the variations in strengths, formulations or routes of administration.

Additional information on these drugs, including the current Product Monograph, is available by search of Health Canada's Drug Product Database.

Report health or safety concerns

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  
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