Tag: FDA
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Farxiga / Invokana / Jardiance: Reports Of Stroke, DVT, Pulmonary Embolism, And Kidney Damage Being Investigated By FDA, But No Label Changes, Yet
Two "Potential Signals of Serious Risks/New Safety Information Identified By FAERS" Reports From 2015 Were Not Made Public By FDA Until February – March 2016 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE:…
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Medical Study Finds Higher Risk Of Ketoacidosis With Invokana Prescribed “Off-Label” To Patients With Type 1 Diabetes
In May 2015 FDA Issued A Warning That Invokana, Farxiga, And Jardiance Are Assoicated With This Serious Side Effect And Other Adverse Reactions (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada…
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Invokana Cases Involving Diabetic Ketoacidosis And Kidney Problems Reported As Adverse Drug Events To FDA
Farxiga, Jardiance, And Other New SLGT2 Diabetes Drugs Also Cause Metabolic Acidosis As Well As Other Serious Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada Warns About Link Between…
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Xarelto Clinical Trial Issue May Lead To Dosage Level Testing For All New Oral Anticogaulant Drugs
Medical Journal Article Says FDA Might Make This Change For Patients Using Eliquis, Pradaxa, Savaysa, Or Xarelto (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Xarelto trial results reaffirmed despite faulty device (Reuters,…
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FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors
This Follows October 2015 Safety Alert By Health Canada Concerning Increased Risks Of Kidney Problems (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada Warns About Link Between DKA & Popular Diabetes…
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Hepatitis C Drugs Viekira Pak And Technivie Require Warnings Label Changes Due To Liver Injury Reports
FDA Says The Timing Of Liver Injury Suggests That These Are Side Effects, Especially In Patients With Advanced Cirrhosis (Posted by Tom Lamb at DrugInjuryWatch.com) Viekira Pak and Technivie are relatively new…
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Xarelto, Savaysa, Pradaxa, And Eliquis: Safety Secondary To Ease Of Use Is “A Major Wrong Turn” Says Drug Watchdog Group
This New Generation Of Oral Anticoagulants Has Bleeding-Related Adverse Reactions Including Gastrointestinal And Intracranial Bleeds (Posted by Tom Lamb at DrugInjuryWatch.com) The ISMP QuarterWatch published on September 23, 2015 includes an examination…
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August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect
These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________…
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Will There Be Another Drug Label Change For YAZ And Other Drospirenone (DRSP) Birth Control Pills, As FDA Required For Ortho Evra Years Ago
Since Bayer Revised YAZ Label In April 2012 There Has Been More Medical Evidence That DRSP Pills Increase Risks Of Blood Clot Side Effects Like DVT And PE (Posted by Tom Lamb at…