Category: “Dear Doctor” Letters
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Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss
She Went to the Local ER With Loss of Vision 11 Days After Receiving an Intravitreal Syfovre (Pegcetacoplan) Injection (Posted by Tom Lamb at Drug Injury Watch) In the March 2024 edition of the American…
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Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists
A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation (Posted by Tom Lamb at Drug Injury Watch) UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current…
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Beovu Drug Label Change in December 2021 Adds More Information About Vision Loss Side Effects
Provides "risk factors and possible mechanism" for Beovu-related Retinal Vasculitis and Retinal Vascular Occlusion (Posted by Tom Lamb at Drug Injury Watch) Update: "Novartis Finally Issues Revised Beovu Prescribing Information for US in February 2022"…
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Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant
European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change (Posted by Tom Lamb at DrugInjuryWatch.com) A recent periodic review of Gilenya safety data by the European Medicines…
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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 Use By Patients With Major Cardiovascular Disease Associated With Higher Risk Of Deaths
New Drug Safety Warning: Uloric Should Be Avoided When There Is Prior Myocardial Infarction, Stroke, Or Unstable Angina (Posted by Tom Lamb at DrugInjuryWatch.com) From this Drug Safety Update issued July 17,…
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Tasigna Side Effects Include Ischemic Cerebrovascular Events, Ischemic Heart Disease, And Peripheral Arterial Occlusive Disease
Less Warning About These Atherosclerosis-Related Diseases By Novartis In The US, It Seems, Compared To What Has Been Done By The Drug Company In Canada (Posted by Tom Lamb at DrugInjuryWatch.com) Tasigna…
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Ocaliva Black-Box Warning About Liver Failure Due To Incorrect Doses Added In Early 2018
This Ocaliva Label Change Follows September 2017 Dear Doctor Letter Sent By Intercept Pharmaceuticals (Posted by Tom Lamb at DrugInjuryWatch.com) An earlier blog post, "Will Ocaliva Get Black-Box Warning For Liver Injury…
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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…