Tag: FDA
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Invokana Lawsuits Are Expected To Be Filed While FDA And Other Drug Regulators Investigate Side Effects Reports
Drug Injury Lawyers Also See Possible Farxiga And Jardiance Cases For Patients Who Have Ketoacidosis, Kidney Failure, Stroke, Or Heart Attack (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada Warns About…
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Farxiga / Jardiance / Invokana Safety As Regards Diabetic Ketoacidosis Now Being Studied By Health Canada In Addition To Current FDA Investigation
Institute For Safe Medication Practices Signal For Invokana Kidney Failure Risks Seems To Apply To Farxiga, Jardiance, And Other SGLT2 Diabetes Drugs Also (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada…
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Multiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac Failure, Interstitial Lung Disease, And Hepatotoxicity
In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action? (Posted by Tom Lamb at DrugInjuryWatch.com) Pomalidomide (brand name:…
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With Zofran – Birth Defects Lawsuits Filed, How Will GlaxoSmithKline Update Its Drug Label To Comply With New FDA Rule Effective June 2015
New FDA Rule Requires Drug Company To Replace Current Simple Pregnancy Category Designation With A Summary Of The Risks Of Using Zofran During Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) ____________________________ UPDATE: …
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Attention Deficit Hyperactivity Disorder Drugs Concerta And Ritalin Get New Warnings For Rhabdomyolysis In US And Priapism In Canada
Muscle-Wasting Side Effect "Rhabdo" Seems To Apply To Entire ADHD Class Of Drugs Given That April 2015 FDA Letter Was Sent To All Manufacturers (Posted by Tom Lamb at DrugInjuryWatch.com)We start in the US where an April…
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Diabetes Drugs Kombiglyze And Onglyza: Heart Failure Side Effect Seems To Be Valid, And FDA Notes There Is A Possible Increased Risk Of All-Cause Mortality
As Analysis Did Not Reveal Causes Of The Increase In Death Incidents, FDA Asks Its Advisory Committee To Discuss This Safety Issue At April 2015 Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "AstraZeneca, Takeda Diabetes Drugs…
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Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting
These Two New AstraZeneca Diabetes Medications With Saxagliptin Are Part Of The Incretin Mimetic Class Of Drugs (Posted by Tom Lamb at DrugInjuryWatch.com)At an April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, results of the…
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Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya
ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical" (Posted by Tom Lamb at DrugInjuryWatch.com)The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for…
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UK Drug Safety Regulator Issues New Warnings About The Use Of Depakote / Depacon / Depakene By Women During Pregnancy
Updates Information About Extent Of Serious Developmental Disorders Such As Autism Spectrum Disorders (ASD) As Well As Congenital Malformations And Birth Defects Like Spina Bifida (Posted by Tom Lamb at DrugInjuryWatch.com) Depakote, Depakote CP, and Depakote ER (divalproex sodium),…
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Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths
While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair (Posted by Tom Lamb at DrugInjuryWatch.com)In September 2014 the FDA issued an update about its…