Health Canada Advisories & Warnings
posts safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties.
The Health Product InfoWatch (formerly The Canadian Adverse Reaction Newsletter)
is a reputable source of adverse reaction information and is published quarterly, in January, April, July and October of each year. This publication alerts health professionals to potential signals detected through the review of case reports submitted to Health Canada. Index of Published Newsletters.
You can also search Health Canada's Drug Product Database Online Query for more complete descriptions of drugs, their use, contraindications and potential risks
Drug Advisories, Warnings & Recalls
Oct. 24/11 — STRATTERA (atomoxetine) — a medicine that is used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults — can increase heart rate and blood pressure. Patients and their caregivers should be aware of the recommendations listed on the Health Canada site.
Oct. 13/11 — Citalopram dose-related heart risk — The heart-related safety of the prescription antidepressant citalopram is being reviewed in light of new study data suggesting that high doses (60 mg/day) can affect the electrical activity of the heart. The changes in electrical activity could potentially lead to serious, possibly fatal abnormal heart rhythms.
Newer antidepressants linked to serious lung disorder in newborns (Mar.10/06) — Health Canada is advising women who are taking antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRI) and who are pregnant or intend to become pregnant to discuss the situation with their doctor due to potential risks to the baby.
Important safety information on Paxil (paroxetine) and increased risk of cardiac defects following exposure during first trimester of pregnancy (Dec. 22/05) — Health Canada endorsed important safety information on Paxil (paroxetine):
Additional study shows use of Paroxetine in first trimester of pregnancy may have small increased risk of heart-related birth defects, compared to other antidepressants.
Use of paroxetine [Paxil] in first trimester of pregnancy may have a small increased risk of birth defects, compared to other antidepressants (October 2005) — Health Canada endorsed important safety Information on Paxil (paroxetine):
GlaxoSmithKline Inc., following discussions with Health Canada, is informing patients of new safety information regarding the use of paroxetine during the first trimester of pregnancy. [Note: …duplicated text of a letter from GlaxoSmithKline Inc.]
Health Canada advises consumers about important safety information on atypical antipsychotic drugs and dementia (June 2005) —
Health Canada is advising Canadians about the risks to elderly patients suffering from dementia, who take second-generation antipsychotic medications, also referred to as atypical antipsychotics.
Health Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants (June 2004) —
Health Canada is advising Canadians that Selective Serotonin Re-uptake Inhibitors (SSRIs) and other newer anti-depressants, now carry stronger warnings. These new warnings indicate that patients of all ages taking these drugs may experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others.
Health Canada endorsed important safety information on ZOLOFT (sertraline hydrochloride) (June 2004) —
Pfizer Canada Inc., following discussions with Health Canada, would like to inform you of important safety information regarding the possibility that SSRIs (selective serotonin reuptake inhibitors) and other newer antidepressants may be associated with behavioural and emotional changes, including risk of self-harm. [Note: …duplicated text of a letter from Pfizer Canada Inc.]
Ottawa warns of suicide risk for teens on anti-depressants (PDF no longer available) (February 2004) —
Mounting concerns over the safety of prescribing a new generation of anti-depressants to children and teenagers has prompted Health Canada to issue a rare public warning to reconsider their use because the popular drugs may actually increase the risk of suicide.
Updated May 29, 2018