Category: FDA Drug Safety Oversight
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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…
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Invokana / Farxiga / Jardiance: Urinary Tract Infections Leading To Urosepsis And Pyelonephritis Are Lesser Known Side Effects
To Date, More Attention Paid To The Association Between These Sodium-Glucose Cotransporter-2 Inhibitors And Diabetic Ketoacidosis Or Acute Kidney Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Over the past year the FDA…
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Summer 2016 Update On Diabetes Medicines Invokana / Farxiga / Jardiance: Drug Label Changes And Safety Investigations
According To Drug Regulators, New Possible Side Effects Include: Fatal Cases Of Ketoacidosis; Leg, Foot, And Toe Amputations; And, Lactic Acidosis (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Invokana “Black-Box Warning” For…
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Summer 2016 Update On ED Drugs Viagra / Cialis / Levitra: Medical And Legal Developments
Melanoma Skin Cancer: FDA Is Evaluating The Need For Regulatory Action; More Lawsuits Filed; Another Research Study (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________________ UPDATE: IN RE: Viagra (Sildenafil Citrate) and Cialis (Tadalafil)…
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Zecuity Recall: Teva Migraine Drug Patch Gets FDA Warning About Reports Of Serious Burns And Potential Permanent Scarring
Drug Company Announces It Will Recall Zecuity Skin Patches From Pharmacies As Well As Temporarily Suspend Sales, Marketing, And Distribution Of Product (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Zecuity Migraine…