Category: FDA Drug Safety Oversight
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FDA Introduces A New Web Site Intended To Give The Public More Insight About Agency’s Work
FDA Basics: Site Seeks To Present Information To Consumers And Patients In Useful And User-Friendly Format (Posted by Tom Lamb at DrugInjuryWatch.com) On January 12, 2009 Dr. Joshua Sharfstein, Principal Deputy Commissioner of the…
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FDA Wants Studies Done On Byetta Safety, With Focus On Pancreatitis, Pancreatic Cancer, Thyroid Neoplasm, And Acute Renal Failure
FDA Letter About Byetta Sent To Amilyn In October 2009; Drug Company Tries To Downplay, But Investors React When They Learn About It In December 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) On October…
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A New Year’s Resolution For The FDA, As Recommended By The GAO
FDA Needs To Restructure Its Staff In Order To Better Monitor Emerging Drug Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-December 2009 the Government Accounting Agency (GAO) — often referred to as…
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FDA Finds It Unlikely That Vytorin Or Zetia Increases Risk Of Cancer, But Such A Link Is Possible
December 2009 Update From FDA For Its August 2008 Early Communication About Safety Review of Ezetimibe / Simvastatin (Vytorin) And Ezetimibe (Zetia) (Posted by Tom Lamb at DrugInjuryWatch.com) On December 22, 2009 the FDA…
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December 2009: Voltaren Gel And Other Products Containing Diclofenc Sodium Linked To Liver Problems
"Dear Doctor" Letter From Endo And Novartis Offers Information About Prevention And Diagnosis Of Drug-Induced Liver Injury (DILI) (Posted by Tom Lamb at DrugInjuryWatch.com) On December 4, 2009 the FDA issued this MedWatch alert, "Voltaren…
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Diet Drug Meridia Has Possible Cardiovascular Risks, Including Stroke, Heart Attack, And Cardiac Death
FDA Early Communication About Meridia (Sibutramine) Side Effects Issued by Agency In November 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________________ UPDATE: Abbott Pulls Meridia in U.S. Amid FDA Safety Concerns (10/8/10, Bloomberg) Abbott…
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Diabetes Drug Byetta Linked To Kidney Problems And Cases Of Renal Failure
October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2009 the Drug Safety Update Newsletter alerted us about reports of kidney-related…
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FDA’s Sentinel Initiative Project: An Overview, Progress To Date, And Next Steps
Presentation Made At September 17, 2009 FDA Drug Safety Oversight Board Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) At the September 17, 2009 meeting of the FDA Drug Safety Oversight Board (DSB), members heard…
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FDA Transparency Task Force Will Hold Its Second Public Meeting On November 3, 2009
Emerging Safety Issues Concerning FDA-Regulated Products Is One Issue For Discussion Listed in October 2009 Federal Register Notice (Posted by Tom Lamb at DrugInjuryWatch.com) In the Federal Register for October 5, 2009 the FDA…