Category: FDA Drug Safety Oversight
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Lyrica Associated With Higher Risk Of Major Birth Defects When Taken During First Trimester Of Pregnancy According To Recent European Medical Study
Animal Studies Have Lyrica Possibly Linked To Skeletal Malformations, Neural Tube Defects, And Other Abnormalities, But Safety Data On Lyrica Use During Human Pregnancy Are Scarce (Posted by Tom Lamb at DrugInjuryWatch.com) …
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A Tecfidera Label Change Modifying Warnings About Progressive Multifocal Leukoencephalopathy (PML) Was Done In February 2016 With Little Notice
Biogen Idec First Added Information About Tecfidera Being Assoicated With PML Brain Infection Back In December 2014, After An FDA Drug Safety Communication Was Issued (Posted by Tom Lamb at DrugInjuryWatch.com) Tecfidera…
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Acute Kidney Injury Caused By Heartburn Medicines In Class Of Drugs Called Proton Pump Inhibitors (PPIs), Such As Nexium, Prilosec, And Prevacid
PPI-Induced Acute Interstitial Nephritis Is A Kidney-Related Side Effect That Has Been Known About For Many Years, But FDA Only Mandated A Drug Label Change In December 2014 (Posted by Tom Lamb at…
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Possible Linzess Recall By FDA Suggested By Phase Five Research Analyst Report, Which Has Become A Bit Of A Mystery
Here Are Some Of The "Findings" From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: "Synergy Petitions FDA…
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Possible Linzess Recall By FDA Suggested By Phase Five Research Analyst Report, Which Has Become A Bit Of A Mystery
Here Are Some Of The "Findings" From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: "Synergy Petitions FDA…
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Onglyza, Nesina, And Similar Diabetes Drugs Get FDA Drug Safety Warnings About Risk Of Heart Failure Side Effect
Set Of Newer Diabetes Medications Containing Saxagliptin And Alogliptin Also Being Investigated By FDA For Increased Risk Of Renal Failure (Posted by Tom Lamb at DrugInjuryWatch.com) On April 5, 2016 the FDA…
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Onglyza, Nesina, And Similar Diabetes Drugs Get FDA Drug Safety Warnings About Risk Of Heart Failure Side Effect
Set Of Newer Diabetes Medications Containing Saxagliptin And Alogliptin Also Being Investigated By FDA For Increased Risk Of Renal Failure (Posted by Tom Lamb at DrugInjuryWatch.com) On April 5, 2016 the 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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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…