Canada Issues Warning On Antipsychotics In Pregnancy

Following an update in the United States earlier this year, Health Canada announced that it is advising healthcare professionals and consumers that the prescribing information for the entire class of antipsychotic drugs is being updated to include information on a pregnancy risk.The antispychotics covered by the update include <"http://www.yourlawyer.com/topics/overview/abilify">Abilify, <"http://www.yourlawyer.com/topics/overview/risperdal">Risperdal, <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel, and <"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa, to name just a few.

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

The revised label will contain safety information on potential risks for abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy, said Health Canada.

Earlier this year, we wrote that U.S. health regulators ordered that cautions be added to the labels of ALL antipsychotic drugs regarding their risk of abnormal muscle movements (extrapyramidal symptoms or EPS) and withdrawal syndromes in newborns when used in pregnancy. The new cautions apply to older and new generation antipsychotics, including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax, according to an alert from the U.S. Food & Drug Administration (FDA).

Health Canada warns women taking an antipsychotic and who are pregnant or thinking of becoming pregnant to speak with their physicians about 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.

Antipsychotic drugs are delivered in a variety of strengths and formulations—drops, liquid, tablets, and capsules taken by mouth, as a powder, solution for injection, or via suppository—and can be administered by healthcare professionals in a healthcare setting or taken by patients at home.

Health Canada notified Canadian antipsychotic drugs manufacturers—both typical and atypical versions—to update the Product Monographs to include this safety information. A list of approved antipsychotics in Canada can be accessed at (includes brand names, generic equivalents, and the active ingredient): http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_78-eng.php. Hundreds of antipsychotic drugs are sold in Canada and this table provides drug names, but not the variations. Additional information, including the current Product Monograph, can be found by search of Health Canada’s Drug Product Database at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php.

In the United States, according to the FDA, it identified 69 episodes of neonatal EPS or withdrawal in adverse event reports submitted to the agency through October 2008. Among the symptoms listed in the reports: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder. Onset of symptoms ranged from birth to one month later, and the severity varied as well. The FDA indicated that some infants recovered within hours while others needed intensive care and prolonged hospitalization.

Health Canada noted that 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, with symptoms ranging in severity. As in Canada, in some newborns, the symptoms could disappear within hours or days and not require specific treatment, while, in others, symptoms may be more severe and require medical attention.

The FDA updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs to include consistent information about the potential risk for EPS and/or withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy and provided a complete list of the antipsychotics included in this notification on its Website at: http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm.

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