Drug Advisories & Warnings

Health Canada 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 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.

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.

Mar. 20/08 — Patients of Asian ancestry using epilepsy drug carbamazepine may be at increased risk of serious skin reactions.

Dec. 13/06 — Health Canada advises consumers not to use herbal sleep supplement containing habit-forming drug.

Sept. 21/06 — Health Canada Advisory: ADHD Drugs & Uncommon psychiatric adverse events.

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–12KB) (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.

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research promotes and protects public health by assuring that safe and effective drugs are available to Americans. (CDER Report to the Nation: 2004) CDER issues safety alerts for drugs and therapeutic biologics.

Celexa (citalopram hydrobromide): Drug Safety Communication — Abnormal heart rhythms associated with high doses (August 2011) — FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart … can be fatal. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.

Children born to mothers who took Valproate products while pregnant may have impaired cognitive development (June 2011) — [The] FDA is informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.

Antipsychotic drugs: class labeling change — Treatment during pregnancy and potential risk to newborns (February 2011) — FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

suicidal thinking in children and adolescents for attention deficit disorder for Atomoxetine (marketed as Strattera) (September 2005) [Broken link] — the U.S. FDA directed Eli Lilly (Lilly) to revise the labeling for Strattera to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents being treated with this drug. Strattera is currently approved in the United States to treat ADHD in children, adolescents, and adults. Strattera has not been studied in children under 6 years of age.

Suicidality in adults being treated with antidepressant medications (June 2005) — the U.S. FDA is undertaking a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. [The FDA page recommends following this link for more current information: Antidepressant Use in Children, Adolescents, and Adults (May 2007).]

Deaths with antipsychotics in elderly patients with behavioral disturbances (April 2005) — the FDA determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality.

Suicidality in children and adolescents being treated with antidepressant medications (October 2004) — the FDA directed manufacturers of all antidepressant drugs to revise the labeling for their products to include…expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies. [The FDA page recommends following this link for more current information: Antidepressant Use in Children, Adolescents, and Adults (May 2007).]