Tag: Health Canada
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Gilenya Liver Injury Risk Warnings Are Increased, Again, This Time in Canada
Similar Gilenya Drug Label Changes Were Made in Europe and UK During Past Few Months (Posted by Tom Lamb at Drug Injury Watch) On January 18, 2021 Health Canada posted a Gilenya…
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Elmiron Pigmentary Maculopathy Risk Warning Issued by Janssen and Health Canada in December 2020
New Medical Article Describes How to Identify, Image, and Diagnose Pigmentary Maculopathy Caused by Elmiron Use (Posted by Tom Lamb at Drug Injury Watch) On December 15, 2020 a Dear Healthcare Professional…
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Picato May Increase The Risk Of Skin Cancer As Side Effect, Says Drug Regulator Health Canada In July 2020
Picato Skin Cancer Risk Has Been Confirmed By European Drug Regulator; The FDA Is Still Investigating This Picato Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) The topical gel drug Picato (ingenol…
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Gilenya Birth Defects Warnings Issued By Drug Safety Regulators In Canada And Europe — But Not By FDA In The US
Gilenya Increased Risk of Major Congenital Malformations Such As Renal / Kidney And Musculoskeletal Abnormalities, Atrial Septal Defects (Posted by Tom Lamb at DrugInjuryWatch.com) On December 19, 2019 Health Canada issued a…
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Uloric Side Effects Lead To An Increased Risk of Patient Cardiovascular Deaths, Says Health Canada
Drug Safety Warning: Watch For Myocardial Infarction, Stroke, And Cardiac Failure In People Who Are Taking Uloric (Posted by Tom Lamb at DrugInjuryWatch.com) In early November 2019 Health Canada warned that in…
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Risk Of Actemra Associated Liver Injury Being Assessed By Health Canada, With Drug Label Change Likely To Follow
Drug-Induced Liver Injuries Reported In Patients Using Actemra, Including Cases Of Acute Liver Failure Requiring A Transplant (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2019 we learned that Actemra has been…
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Pradaxa-Related Liver Injury: Health Canada’s Drug Safety Review Of Pradaxa Concludes There Is A Link
Remains Unknown Whether Pradaxa Label Change About Liver Damage In Canada Will Be Followed By Similar FDA Action In US (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2018 Health Canada announced…
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Drug-Induced Liver Injury Warning Added To OFEV Label In Canada As Done Earlier In US
This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators (Posted by Tom Lamb at DrugInjuryWatch.com) OFEV (nintedanib) capsules were approved by the FDA in 2014…
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A “Dear Doctor” Letter For Invokana Amputations Side Effect Was Sent September 2017 By Janssen In Canada
In US There Was A “Black-Box Warning” Added On Revised Drug Label Issued In July 2017 But Without Any Such Letter, It Seems (Posted by Tom Lamb at DrugInjuryWatch.com) The “FDA Drug…