Tag: label changes
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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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New FDA Warning That Januvia, Onglyza, Tradjenta, And Nesina Are Associated With “joint pain that can be severe and disabling”
Label Changes About Side Effects For These Type 2 Diabetes Medicines In The Drug Class Called Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2015 the FDA announced…
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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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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 Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems
Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or…
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Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida
In Addition, There Are FDA Warnings That Using Depakote Or Depakene While Pregnant May Put Child At Risk For Having A Lower IQ Score Later In Life (Posted by Tom Lamb at DrugInjuryWatch.com) Depakote…