Tag: FDA
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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…
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Despite The High Number Of Actemra – Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label
June 2017 Investigative Article Published By STAT Calls Into Question FDA Oversight After Drugs Are Approved By Agency (Posted by Tom Lamb at DrugInjuryWatch.com) Actemra (tocilizumab) is approved by the FDA for…
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New MS Drug Ocrevus Gets Possible Bad News About Side Effects Soon After Good News About Sales Projections
Ocrevus – Progressive Multifocal Leukoencephalopathy (PML) Reported As Possible Side Effect In Germany, Says Drug Maker Roche (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2017 the FDA approved Ocrevus (ocrelizumab injection)…
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Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX
FDA-Funded Study About The Use Of Polyethylene Glycol In The Pediatric Population Currently Underway At Children's Hospital Of Philadelphia (Posted by Tom Lamb at DrugInjuryWatch.com) MiraLAX is a popular over-the-counter laxative medicine…
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The Association Between Breast Implants And Anaplastic Large Cell Lymphoma (ALCL) Is Better Understood In Recent Years
Focus On Medical Journal Articles About The Diagnosis And Treatment Of This Breast Implants Lymphoma Cancer Published In 2015 (Posted by Tom Lamb at DrugInjuryWatch.com) In January 2011 the U.S. Food and…
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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…