Category: FDA Drug Safety Oversight
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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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European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)
Recommends That Xeljanz Should Be Used With Caution In Patients At High Risk Of Blood Clots As Well Aa In Patients Older Than 65 Years Of Age (Posted by Tom Lamb at DrugInjuryWatch.com)…
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Lemtrada Adverse Events May Occur More Frequently Than Previously Noted By Drug Safety Regulators And Researchers
Ten Deaths Identified As Being Most Probably Related To Lemtrada, With Six Of These Cases Not Previously Reported, According To New Study (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: "Dear Healthcare Professional…
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Fournier’s Gangrene Is A Side Effect Of Farxiga, Invokana, Jardiance, And Other SGLT2 Inhibitor Diabetes Drugs — Or Is It?
At The Recent American Diabetes Association (ADA) Scientific Sessions There Was An Expression Of Doubt About Warnings For This Association (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2018 the FDA required…
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Xeljanz Warning For Increased Risk Of Blood Clots And Death With Higher Dose Used For Ulcerative Colitis
"Black Box Warning" For Xeljanz 10 mg Twice Daily Dose Required By FDA In July 2019 Follows Regulatory Action In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) A Xeljanz FDA Drug Safety…
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June 2019 Actemra Label Change Adds Warnings About Increased Risks Of Liver Injury After Months Or Years Of Use
Serious Cases Of Hepatic Injury Some Of Which Have Resulted In Liver Transplant Or Death Reported As Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On May 21, 2019 we posted this…
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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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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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FDA: More Reports Of Diabetes Drugs Invokana, Jardiance, And Farxiga Being Associated With Fournier’s Gangrene
Serious Infection In The Genital Area Seems to Be A Drug Class Side Effect Of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) A new FDA analysis article published in…