Canada Officials Warn of Antipsychotic Pregnancy Risks - Consumer Justice Foundation

Canada Officials Warn of Antipsychotic Pregnancy Risks

Written by Andrew Sarski on June 30, 2011


Antipsychotics are a class of medication approved for the treatment of psychiatric problems like schizophrenia and bipolar disorder, although they are also often prescribed by physicians for off-label uses that have not been approved by the FDA. Doctors have the prerogative to prescribe pharmaceutical drugs for conditions that the FDA has not approved them for if they deem the treatment safe and effective. Unfortunately, antipsychotic drugs are known to have the ability to cross the placenta during pregnancy and adversely affect unborn children.

New Warning Labels for Antipsychotic Drugs in Canada

New labels for antipsychotic drugs in Canada will warn Canadian patients of the potential side effects of antipsychotics, including the risk of abnormal muscle movements and withdrawal symptoms in newborns when antipsychotics are taken during the third trimester of pregnancy. These new warnings, which apply to all antipsychotic drugs on the Canadian market, indicate that fetal exposure to antipsychotics may increase an infant’s risk of suffering from severe problems like abnormal muscle tone and withdrawal symptoms like agitation, sleepiness, tremors, and difficulties with breathing and eating. According to Health Canada, the severity of the atypical antipsychotic pregnancy risk ranges from symptoms that pass within hours to those requiring medical attention. The abnormal movements potentially associated with antipsychotic drugs are known as extrapyramidal signs (EPS).

Similar Antipsychotic Warning Issued in U.S.

A similar antipsychotic warning was issued by the FDA in the U.S. earlier this year, alerting American consumers of the potential pregnancy risks associated with antipsychotic drugs. The FDA also required antipsychotic drug makers to update their drugs’ warning labels to include these potential side effects. This FDA warning was based on adverse event reports filed by healthcare providers and patients in the United States. According to these reports, at least sixty-nine cases of neonatal EPS have been linked to antipsychotic drugs in the U.S., with symptoms appearing from birth to one month after birth.

Risks of Antipsychotic Use During Pregnancy

Because of the potential for antipsychotic drugs to cause major side effects among infants exposed to the drugs during pregnancy, Health Canada and the FDA have advised physicians to educate patients on the benefits and risks associated with antipsychotic use during pregnancy. The agencies have also advised physicians whose patients were on antipsychotics during the third trimester of pregnancy to monitor the newborn for signs of EPS or withdrawal. Women currently taking an antipsychotic like Seroquel, Zyprexa or Risperdal, who are pregnant or planning to become pregnant should consult their healthcare provider immediately. The FDA has also suggested that it may be dangerous for patients to stop taking their antipsychotic medications without first talking to their doctor.

Legal Help for Victims of Potential Antipsychotic Side Effects

Health Canada’s online drug product database includes hundreds of antipsychotic medications, both brand-names and generics, in different formulas, strengths and types of administration. The potentially dangerous antipsychotic drugs include: aripiprazole (Abilify), methotrimeprazine (Nosinan, Nozinan, Levoprome), clozapine (Clozaril), quetiapine (Seroquel), risperidone (Risperdal), perphenazine (Trilafon), olanzapine (Zyprexa), loxapine (Xylac), and haloperidol (Haldol, Serenace).

The side effects potentially associated with antipsychotic drug use during pregnancy are severe and may cause life-altering problems for affected children. If you took an antipsychotic drug while pregnant and your child was born with potential antipsychotic side effects like muscle problems or withdrawal symptoms, contact a defective drug attorney immediately. Drug manufacturing companies are responsible for the safety and effectiveness of their medications, and should be held liable for any adverse side effects sustained by consumers of their products. Your child may be entitled to lifetime care or financial compensation for his injuries, which you can collect by filing a defective drug lawsuit against the drug maker responsible for manufacturing the dangerous drug.

Posted Under: FDA - Food and Drug Administration
Start Claim Now
Do you deserve compensation?

An attorney will review your situation for FREE and help you found out what really went wrong.

How Can We Reach You?

Please Explain Your Situation

By clicking the "Submit" button below, you agree that law firms you are matched with may contact you by telephone even if you are on a federal or state Do Not Call registry. Up to 10 law firms may respond to your request within approximately 2 weeks. In some cases 3 or more firms may respond to your request after 30 days. Use of this site is subject to our Terms of Use.