Tag: FDA
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Omontys-Related Adverse Reactions And Deaths Update: Are There More Cases Than Initially Disclosed
FDA Adverse Event Report For Omontys Reveals Affymax And Takeda May Have Downplayed Magnitude Of Problems (Posted by Tom Lamb at DrugInjuryWatch.com) When the dialysis – anemia medication Omontys was recalled in February 2013 it…
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Byetta / Januvia / Victoza: Update On Possible Association Between These Newer Diabetes Drugs And Pancreatic Cancer As A Side Effect
Drug Safety Regulatory Developments And The Ongoing Academic Discussions About Provocative 2013 Medical Journal Article By Peter Butler At UCLA (Posted by Tom Lamb at DrugInjuryWatch.com)We last wrote about the possible association between pancreatic…
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Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy
May 2013 Revised Depakote Drug Label Includes "Black-Box" And Warnings About These Congenital Malformations As Well As Decreased IQ Scores In Children (Posted by Tom Lamb at DrugInjuryWatch.com) As indicated below, in May 2013…
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July 2013 Update: New FDA Action To Be Taken In Or About September On Issue Of Drug Label Revisions By Generic Manufacturers
Allowing Supplemental Applications For Proposed Labeling Changes Might End Federal Preemption Shield From Legal Liability That Came With Mensing Ruling (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA’s long-awaited proposed rule on…
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Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe
Is The FDA Doing Enough About Birth Control Products That Contain Third Generation Or Fourth Generation Progestins And Are Associated With Higher Risks Of Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) A January 3,…
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December 2012 Pradaxa Label Change: Contraindication: Use By Mechanical Heart Valves Patients
A Look At The Events And The Evidence Leading Up To This Latest FDA Action Concerning The Safety Of Pradaxa (Posted by Tom Lamb at DrugInjuryWatch.com) We set the stage with this December 19,…
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Generic Drugs Post-Mensing Ruling: One Proposed Solution To The Legal Compensation And FDA Drug Safety Problems Supreme Court Created
At Least, This November 2012 Article In The New England Journal Of Medicine Makes The Point That Something Needs To Be Done Soon, Rather Than Later (Posted by Tom Lamb at DrugInjuryWatch.com) The June 2011…
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Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions
While Doctors And Hospitals Handle Patients Having Serious Bleeding Events From Pradaxa, The Drug Company Along With The FDA Still Say All Is Fine, Here (Posted by Tom Lamb at DrugInjuryWatch.com) There was a flurry of activity in the…
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New Obesity Drug Qsymia / Qsiva Gets Gets Negative Opinion By European Medicines Agency (EMA)
Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) On October 18, 2012 European drug regulators…
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Multaq Associated Lung Disease And Pulmonary Toxicity Pointed Out By New Safety Warnings In September 2012 Revised Label
Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening (Posted by Tom Lamb at DrugInjuryWatch.com) Multaq (dronedarone) is a drug used to treat abnormal heart rhythm (atrial…