Tag: drug safety
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Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020
Beovu Use Increased Risks Of Retinal Vasculitis And Retinal Vascular Occlusion, Which Can Lead To Blindness (Posted by Tom Lamb at DrugInjuryWatch.com) In early June 2020, the FDA approved a label update…
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Picato Skin Cancer Risk Findings Are Confirmed By European Drug Safety Panel In April 2020
FDA Investigation Of This Picato Drug Safety Issue Seems To Be Still Ongoing, Despite Picato Recall In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) A European drug safety panel announced in April…
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Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report
This Is A Reversal Of March 2020 Novartis Position That Current Beovu Drug Label Provided Sufficient Warnings (Posted by Tom Lamb at DrugInjuryWatch.com) According to an April 2020 news report, Novartis has…
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Lemtrada Cardiovascular Reactions Can Occur Within 1-3 Days Of Infusions In People Without Any Identifiable Risk Factors
Unpredictable And Potentially Fatal Immune-Mediated Reactions Can Occur Within Months And Up To At Least 4 Years After Lemtrada Treatments (Posted by Tom Lamb at DrugInjuryWatch.com) The UK Medicines and Healthcare Products…
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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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Hemophilia Drug Hemlibra: Adverse Events Reports And Patient Deaths Raise Some Concerns
November 2019 NEJM Letter Points Out Possible Public Health Issue For Hemlibra Used By Hemophilia A Patients (Posted by Tom Lamb at DrugInjuryWatch.com) We recently learned about drug safety issues involving Hemlibra…
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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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Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible
Serious Side Effects For Xeljanz 10 mg Dose Found In Pfizer Post-Marketing Study Leads To New European Drug Safety Regulatory Action (Posted by Tom Lamb at DrugInjuryWatch.com) The serious side effects associated…
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Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label
Symptoms Developed Within Just One Day Of Lemtrada Injections, And Can Lead To Patient Death Or Permanent Disability Says FDA (Posted by Tom Lamb at DrugInjuryWatch.com) In late November 2018 this FDA…