Health Canada

Health Canada reviewed the potential risk of liver injury with Pradaxa after receiving reports of severe liver injury from the manufacturer. The manufacturer was asked to provide all available data on Pradaxa and the risk of liver injury.

Health Canada carried out a safety review to look at the potential risk of seizures in patients taking finasteride after cases of seizures were published in the WHO Pharmaceuticals NewsletterFootnotea.

This safety review was carried out to look at new information in the scientific literature that has emerged since the completion of a previous review in 2012 about the risk of Clostridium difficile infection with proton pump inhibitor use. Clostridium difficile infection ranges from mild diarrhea...

Health Canada reviewed the potential risk of a type of skin reaction known as subacute cutaneous lupus erythematosus(SCLE) with the use of PPIs after a published article that found these drugs may contribute to the reaction.

Health Canada reviewed this issue because a published study found a link between SSRI exposure during pregnancy and an increased risk of autism in children. Autism is a developmental disability with lifelong impact. It affects a child's ability to communicate and interact with others.

After receiving two Canadian case reports involving canagliflozin, Health Canada reviewed the potential risk of PRES in patients treated with SGLT2 inhibitors who have developed DKA. SGLT2 inhibitors have been linked to an increased risk of DKA, which is a serious complication of diabetes....

The minerals stored within the bones help provide strength. Bones that have fewer minerals (less bone mineral density) are more likely to become brittle and break (fracture). A safety review was carried out by Health Canada to evaluate the risk of bone-related side effects of using SGLT2...

Ketones are a type of waste product that the body creates when it breaks down fat to use for energy. If ketones begin to build up to toxic levels in the blood (a condition known as diabetic ketoacidosis) it can lead to symptoms such as difficulties in breathing, stomach pain, nausea and vomiting,...

A safety review was done to evaluate the potential risk of acute kidney injury and the use of two SGLT2 inhibitors, Invokana (canagliflozin) or Forxiga (dapagliflozin). This issue was identified following new safety information received from the manufacturer of Invokana following the marketing of...

The European Medicines Agency completed a safety review of strontium ranelate, a drug available by prescription only in Europe at a dose of 680 mg per day and used to treat osteoporosis that is considered severe due to the high risk of fracture. Analysis demonstrated that the increased risk of...

Health Canada reviewed the risk of kidney injury with Tecfidera after finding international cases of this risk in patients treated with Tecfidera. These cases were found during routine review of information received from the manufacturer. In Canada, the product information for Tecfidera has...

This safety review was carried out to look at the potential link between non-prescription topical antiseptic chlorhexidine products and serious allergic reactions, and to determine if there is a need for additional labelling requirements. Symptoms of a serious allergic reaction, including...

The product information for tramadol warns of the risk of serious breathing problems when too much is taken. Health Canada's safety review on codeine (another opioid drug) to study the risk of serious breathing problems in children and adolescents triggered this review for tramadol. Tramadol is...

After reviewing an article about the wearing out of the Trifecta heart valve 34 months after it was implanted in a patient, Health Canada carried out a safety review of related patient reports both in Canada and internationally. When a heart valve implant does not function properly it can place...

Health Canada carried out a safety review after finding international cases of DRESS suspected of being linked with the use of Uloric (febuxostat). DRESS describes a group of rare, but serious and potentially life-threatening, side effects of a medication, with symptoms such as fever, severe skin...

Health Canada carried out a safety review to assess the potential risk of severe side effects in infants and young children with the use of viscous lidocaine. The issue was triggered after the United States Food and Drug Administration issued a safety announcement that viscous lidocaine should...

Health Canada carried out a safety review to assess the risk of birth defects with the use of ondansetron, as part of routine health product monitoring and because this drug is not authorized for sale in Canada to treat nausea and vomiting during pregnancy. The use of ondansetron during pregnancy...

Health Canada initiated a safety review following a report by the European Medicines Agency about the potential drug-drug interaction between phenylephrine and acetaminophen. These drugs are often found together in over-the-counter health products including those for treating cold, flu and...

A safety review was carried out to evaluate a potential link between serious allergic reactions (hypersensitivity reactions) and over-the-counter acne products containing either benzoyl peroxide or salicylic acid applied on skin (topical). As part of its routine health product monitoring, Health...

Summary Safety Review - Over-the-Counter Products Containing Pseudoephedrine - Assessing the Potential Risk of Inflammation and Injury of the Large Intestine due to Insufficient Blood Supply (ischemic colitis)