Tag: label changes
-
Keytruda, Opdivo, And Yervoy May Be Associated With Vision Loss And Retinal Detachment In Addition To Uveitis
In June 2017 The FDA Announced It Is Evaluating Possible Drug Label Changes And The Need For Other Regulatory Actions (Posted by Tom Lamb at DrugInjuryWatch.com) According to the document “Potential Signals…
-
Multiple Sclerosis Drug Tecfidera: FDA Mandates January 2017 Label Change Which Adds Warnings About Liver Injury Cases
Besides Hepatotoxicity, Progressive Multifocal Leukoencephalopathy, Renal Toxicity, And Other Safety Issues Have Surfaced Since Clinical Trials (Posted by Tom Lamb at DrugInjuryWatch.com) Tecfidera (dimethyl fumarate) was approved by the FDA in 2013…
-
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…
-
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:…
-
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…
-
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…
-
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…
-
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…
-
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…