Tag: FDA
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Iclusig: Leukemia Drug With Many Different Serious Side Effects Had More Warnings Added In November 2016
Black-Box Warning Now Includes Venous Thromboembolism As Well As Various Types Of Arterial Occlusions, And There Are More New Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) Iclusig (ponatinib) is a kinase…
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Diabetes Medicine Invokana Gets New Warning About Lower Limb Amputation Added To Drug Package Insert In Canada
This December 2016 Label Change Mandated By Health Canada, However, Does Not Apply To Jardiance, Farxiga, And The Rest Of SGLT2 Inhibitors Class Of Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE:…
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Jardiance Might Become The Next Blockbuster Diabetes Drug Despite Ketoacidosis And Acute Kidney Injury Side Effects
December 2016 FDA Determination About Cardiovascular Benefits Also Includes Increased Drug Safety Warnings Label Change For Jardiance (Posted by Tom Lamb at DrugInjuryWatch.com) After the December 2, 2016 decision by the FDA…
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Is Eliquis Really A Safe Alternative To Warfarin For A Patient On Hemodialysis, One Pharmacist Wonders
The Prescribing Information For Eliquis Suggests Such Use Is Safe, But There Is Limited Clinical Study Data In Support (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________ UPDATE: Here are two new…
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Harvoni, Sovaldi, Viekira Pak, And Other Direct-Acting Antivirals Get Black-Box Warning: Risk Of Hepatitis B Virus Reactivation
October 2016 FDA Drug Safety Communication Warns About These Relatively New Drugs Which Are Increasingly Popular For Treating Chronic Hepatitis C (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: “New Safety Issue:…
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Savaysa Label Change In September 2016 Points Out There Is No Established Way To Reverse Its Anticoagulant Effects
Use Of Prothrombin Complex Concentrates (PCC) Or Other Procoagulant Reversal Agents Have Not Been Evaluated In Clinical Outcome Studies (Posted by Tom Lamb at DrugInjuryWatch.com) In relevant part, from a September 15, 2016…
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The Essure Birth Control Product: Safety, Regulatory, And Legal Developments Over The Past Several Months
Increasing Number Of Women Who Have Allegedly Been Harmed By The Essure Inserts Have Filed Lawsuits Against Bayer (Posted by Tom Lamb at DrugInjuryWatch.com) Bayer’s Essure® product is a permanent birth control…
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FDA Mandates Label Change Warning About Fatal Cases Of Ketoacidosis For All Diabetes Drugs Known As Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors
This Class Of (Heavily Advertised) Drugs Includes Farxiga, Invokana, And Jardiance, Which Also Are Linked To Kidney Failure And Heart Attacks Or Myocardial Infarction (Posted by Tom Lamb at DrugInjuryWatch.com) In an…
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Xarelto / Savaysa / Eliquis: Antidote Drug AndexXa Is Rejected By FDA In August 2016, Surprising Many Pharma Industry Observers (And Doctors?)
Portola, Which Developed AndexXa, Estimates 100,000 Patients Per Year Suffer From Severe Uncontrollable Bleeding Events That Could Require Such An Antidote (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-August 2016 the US…
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Denosumab Drugs Prolia And Xgeva Linked To QT Interval Prolongation Associated With Hypocalcemia
Australia's Drug Regulator Issues Warnings And Mandates Label Changes, Following Similar Action In Europe; Will FDA Follow Thess Leads? (Posted by Tom Lamb at DrugInjuryWatch.com) In early August 2016 we learned about…