Category: FDA Drug Safety Oversight
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Pradaxa Lawsuits And Settlements: Past, Present, And Future Aspects Are Explained In This 2017 Update Report
The Bottom Line: Pradaxa Is Still Associated With Serious Bleeding Events, Including Patient Deaths, And New Pradaxa Drug Injury Cases Are Still Being Filed (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa (dabigatran)…
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Pending Motion Requests Multidistrict Litigation (MDL) For Farxiga And Xigduo XR Lawsuits Filed In Federal Court
These New Diabetes Drugs Have Increased Risks Of Serious Side Effects Such As Diabetic Ketoacidosis (DKA) And Acute Kidney Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin…
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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…
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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:…