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Important Safety Information on ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary Maculopathy – Janssen Inc.

Cases of pigmentary maculopathy have been reported with long-term use of ELMIRON. These changes may be irreversible, and retinal and vision changes may progress even after cessation of therapy. This medicine is usually used for urinary symptoms and pain associated with interstitial cystitis, a condition that presents with painful and frequent urination. HMC


Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies

Two individuals in the U.K. reported severe allergic reactions to Pfizer BioNTech’s COVID-19 vaccine on December 8, 2020. As vaccine roll-out begins in Canada, Canadians may be wondering about the risks of allergic reactions and if they should receive this vaccine if they have allergies to foods or other medications. Health Canada has reviewed the...


Updates to safety labelling for benzodiazepines and benzodiazepine-like drugs

Benzodiazepines and benzodiazepine-like prescription drugs—commonly used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle pain—can lead to problematic use and substance use disorder. To help mitigate these risks, Health Canada is asking manufacturers to update their safety warnings to include more prominent and consistent messaging for...


Benzocaine products should not be used in children under two years of age

Health Canada is reminding parents and caregivers not to use products containing benzocaine in children under two years of age. Benzocaine products may cause a serious blood condition called methemoglobinemia (MetHb), which reduces the ability of red blood cells to deliver oxygen throughout the body. Over-the-counter (OTC) products that contain benzocaine are used in children...


Important Safety Information on ALESSE 21 and ALESSE 28: Packages Containing Broken or Split Tablets

Health Canada and Pfizer Canada Inc. have received reports for packages of ALESSE 21 and ALESSE 28 where the blister packages contained a single active (pink) tablet that was broken. This could reduce the dose of hormones and potentially result in an unintended pregnancy due  to insufficient action of the contraceptive hormones levonorgestrel and ethinyl...