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Displaying 1 - 15 of 109 items.
Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality
UPDATED INFORMATION – February 20, 2024
Health Canada worked with manufacturers, clinicians, and other international health regulatory agencies to further assess the risk of increased mortality associated with the use of paclitaxel-coated devices…
AlertHealth professional risk communication | 2024-02-20
Importation of UK-Authorized Potassium Chloride 15% w/v Concentrate for Solution for Infusion due to shortage of Canadian-authorized Potassium Chloride for Injection Concentrate
There is a shortage of Potassium Chloride for Injection Concentrate in Canada due to disruptions in the manufacturing of the products. Given the medical necessity of this product and to help mitigate the shortage, Health Canada has permitted the…
AlertHealth professional risk communication | 2023-10-24
Baxter Intravenous Solution Bags – Potential Leak During Spiking of Administration Port
Intravenous bags of Baxter’s 0.4% Lidocaine & 5% Dextrose Injection 250 mL, 0.9% Sodium Chloride Injection, USP 100 mL and 250 mL, Lactated Ringer’s Injection, USP 250 mL, and Metronidazole Injection, USP 100mL from certain lots have the potential to…
AlertHealth professional risk communication | 2023-10-06
IDHIFA (enasidenib mesylate) – Market Withdrawal and Continued Access
IDHIFA failed to demonstrate improved OS in adult patients with late stage AML and an IDH2 mutation versus conventional care regimens in a Phase 3 confirmatory study evaluating efficacy and safety.
Do not initiate IDHIFA in new patients. IDHIFA is…
AlertHealth professional risk communication | 2023-06-08
ISTODAX (romidepsin) – Restricted Access Program
In 2013, ISTODAX (romidepsin) was authorized under a Notice of Compliance with conditions (NOC/c) for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one…
AlertHealth professional risk communication | 2023-03-20
ZEJULA (niraparib) - Update on the Maintenance Treatment in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in the Second or Later Line Setting
Currently available data from the NOVA study, based on a data cut-off date of October 1, 2020, shows that the median OS may be lower with ZEJULA compared to placebo for patients in the overall non-gBRCAmut cohort and the non-gBRCAmut / Homologous…
AlertHealth professional risk communication | 2023-02-16
RUZURGI (amifampridine) - Authorization Status
UPDATED INFORMATION – January 20, 2023
On January 10, 2023, following a Federal Court of Appeal decision, the June 24, 2021 decision of the Minister of Health on the application of the data protection provisions was restored, and a new Notice of…
AlertHealth professional risk communication | 2023-01-20
EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance to specific SARS-CoV-2 Subvariants
UPDATED INFORMATION – 2023/01/17
Neutralization data for the following SARS-CoV-2 Omicron subvariants have been added to the Canadian Product Monograph: Omicron BA.2.75.2, BF.7, BJ.1, BN.1, BQ.1, BQ.1.1, and XBB. See Table 1 (below) for a summary…
AlertHealth professional risk communication | 2023-01-17
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
On December 9, 2022, Health Canada authorized a new formulation of the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory…
AlertHealth professional risk communication | 2022-12-09
OCALIVA (obeticholic acid) – New Contraindication for the Treatment of Primary Biliary Cholangitis (PBC)
OCALIVA received a Notice of Compliance with Conditions in May 2017 for the treatment of PBC, pending the results of trials to verify its clinical benefit.
OCALIVA is now contraindicated for PBC patients with advanced disease, such as those with Child…
AlertHealth professional risk communication | 2022-12-05
SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Health Canada authorized SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) on November 3, 2022. In order to provide rapid access to the vaccine, Moderna will distribute product vials and cartons labelled in English only with the…
AlertHealth professional risk communication | 2022-11-18
Janus Kinase Inhibitors and the Risk of Major Adverse Cardiovascular Events, Thrombosis (Including Fatal Events) and Malignancy
The final results of a clinical trial conducted with XELJANZ showed higher risks of MACE, thrombosis, malignancy, serious infections and fatal events, compared to TNFi, a group of medicines that suppress the body's natural response to tumor necrosis…
AlertHealth professional risk communication | 2022-10-31
EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance
EVUSHELD (tixagevimab and cilgavimab for injection) may not be effective against certain SARS-CoV-2 Omicron subvariants.
Audience
Healthcare professionals including physicians, pharmacists, nursing staff and public health officials.…
AlertHealth professional risk communication | 2022-10-26
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
On October 7, 2022, Health Canada authorized the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2…
AlertHealth professional risk communication | 2022-10-07
ZOLGENSMA (onasemnogene abeparvovec) and Fatal Cases of Acute Liver Failure
Two cases of fatal acute liver failure associated with ZOLGENSMA have recently been reported internationally. The deaths occurred 6-7 weeks post-ZOLGENSMA infusion, following the initiation of corticosteroid taper. No fatal cases of acute liver failure…
AlertHealth professional risk communication | 2022-09-12