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 in a release
Wednesday.
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.
Some newborns may only experience
these symptoms for hours or days and may not need treatment, while in
others the symptoms may be more severe and need medical attention.
There are hundreds of antipsychotic
drugs sold in Canada, which 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.
Some of the drugs include
risperidone, clozapine, quetiapine, methotrimeprazine, trifluoperazine,
loxapine, olanzapine, perphenazine and haloperidol as well as their
brand-name equivalents.
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.
The Canadian Press