Category: FDA Drug Safety Oversight
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Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.
Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There — Why Not Here, Too (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: This label revision regarding hemophilia…
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Pradaxa Adverse Drug Events (ADEs) Result In Death More Often Than Other Anticoagulants / Blood Thinners ADE Reports
Again In 2012, Pradaxa (Dabigatran) Had Dubious Distinction Of Being Ranked First For Direct FDA Reports Of Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) The October 2013 edition of ISMP QuarterWatch, Data from 2012…
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Benicar Cardiovascular-Related Deaths: FDA Safety Review Which Started In June 2010 Is Still Ongoing In August 2013
When Will Daiichi Sankyo And FDA Report On Additional Studies And Analyses Of Clinical Studies About Cardiovascular Mortality Increased Risks Of Benicar (Posted by Tom Lamb at DrugInjuryWatch.com) In June 2010 the FDA issued…
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Blood Pressure Drug Benicar Causes Serious Intestinal Side Effects Such As Chronic And Severe Diarrhea Months Or Years After Starting Drug
Olmesartan-associated Sprue-like Enteropathy FDA Warning Also Applies To Benicar HCT, Azor, And Tribenzor From Drug Company Daiichi Sankyo (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA has found clear evidence of an association between…
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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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Fate Of Affymax Anemia Drug Omontys Remains Uncertain As FDA And Drug Company Continue To Study Cause Of Drug Reactions
Fresenius Dialysis Clinics Decided To Stop Using Omontys Before FDA Warning Came Out Due To Five Adverse Event Reports From One Day In February 2013 (Posted by Tom Lamb at DrugInjuryWatch.com)The Omontys (peginesatide) injection had…
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Emerging Drug Safety Issue: Possible Increased Risk Of Pancreatic Cancer With Byetta, Januvia, And Victoza — Little Is Known About Long-Term Effects
As “Pancreatitis Is On The Pathway Toward Pancreatic Cancer”, Medical Studies Needed To Determine If GLP-1 Diabetes Medications Linked To Cancers Or Malignancies Involving Pancreas (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: “Cancer of The Pancreas:…
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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…