Search
Returning search results with filters:
Remove filter for
Category: Drugs
Remove filter for
Type: Health professional risk communication
Clear all
Search filters
Type
Audience
Category
Issue
Last updated
Displaying 1 - 15 of 59 items.
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
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
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
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
IMBRUVICA (ibrutinib) - Risk of Serious and Fatal Cardiac Arrhythmias or Cardiac Failure
Serious and fatal events of cardiac arrhythmia or cardiac failure have occurred in patients treated with IMBRUVICA.
Audience
Healthcare professionals including emergency room physicians, hematologists and hematologist-oncologists.…
AlertHealth professional risk communication | 2022-08-29
Distribution of EVUSHELD (tixagevimab and cilgavimab for injection) with English-Only Vial and Carton Labels
EVUSHELD (tixagevimab and cilgavimab for injection) was authorized by Health Canada on April 14, 2022. In order to provide rapid access to EVUSHELD in the context of the global COVID-19 pandemic, AstraZeneca will distribute product vials and cartons with…
AlertHealth professional risk communication | 2022-04-14
Sodium Acetate Injection, USP - Potential for the Presence of Particulate Matter
UPDATED INFORMATION – May 6, 2022
Further to the communication below, issued on March 15, 2022, regarding the potential for the presence of particulate matter in vials of Sodium Acetate Injection, USP (DIN 02139529) from lot 6126554, Fresenius Kabi…
AlertHealth professional risk communication | 2022-03-15
0.9% Sodium Chloride Injection, USP and Lactated Ringer’s Injection, USP - Potential Leak During Pressure Infusion
Intravenous bags of Baxter’s 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL from certain lots have the potential to leak when administered under pressure infusion due to a weak seal formation.
Affected lots are…
AlertHealth professional risk communication | 2022-03-09
Distribution of NUVAXOVID with English-only Vial and Carton Labels
NUVAXOVID was authorized by Health Canada on February 17, 2022. In order to provide earlier access to NUVAXOVID in the context of the global pandemic, Novavax, Inc. will distribute product vials, cartons and package inserts that are in English only for a…
AlertHealth professional risk communication | 2022-02-23
BEOVU (brolucizumab) – Risk of Intraocular Inflammation, Retinal Vasculitis and/or Retinal Vascular Occlusion
An increased incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and retinal vascular occlusion (RO), was observed in patients who received BEOVU 6 mg with every 4 weeks (q4 week) dosing beyond the first 3 doses compared to…
AlertHealth professional risk communication | 2022-02-03
PAXLOVID (nirmatrelvir and ritonavir) - Dosing and Dispensing in Renal Impairment, Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only Labels
UPDATED INFORMATION - July 6, 2022
A new PAXLOVID dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN: 02527804. Pfizer has introduced this new packaging configuration to…
AlertHealth professional risk communication | 2022-01-17
XELJANZ/XELJANZ XR (tofacitinib) – Risk of Major Adverse Cardiovascular Events, Malignancy, Thrombosis and Infection
A post-authorization safety study in RA patients 50 years of age or older with at least one additional CV risk factor showed an increased risk of MACE and malignancy in patients treated with XELJANZ (5 mg BID or 10 mg BID) in comparison to TNFi. An…
AlertHealth professional risk communication | 2022-01-12