Tag: GSK
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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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Actos And Avandia Use Associated With Diabetic Macular Edema, Which Can Lead To Blindness
New UK Study Found Three To Six Times Increased Risk Of Developing This Retinal Eye Disease Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Avandia, Actos May Raise Risk of Macular Edema…
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Popular Seizure And Bipolar Disorder Medication Lamictal Associated With Aseptic Meningitis In August 2010
FDA Working With GlaxoSmithKline To Update Label, Or Package Insert, And Patient Medication Guide To Warn About This Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com)On August 12, 2010 the FDA announced that Lamictal…
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10,000 Avandia Lawsuits Settled For $460 Million While FDA Considers Possible Avandia Recall
During July 13-14, 2010 FDA Advisory Committee Meeting, Glaxo Settles Most Of The 13,000 Avandia Court Cases (Posted by Tom Lamb at DrugInjuryWatch.com) Bloomberg reporters Jef Feeley and Trista Kelley broke the news of…
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When Considering A Possible Avandia Recall, Liver Injury Side Effects Should Be A Factor
Heart Risk Is Current Focus Due To GlaxoSmithKline Past Conduct; But Public Citizen Has Pointed The Liver Failure Case Reports Linked To Avandia, Also(Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, in October…
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September 2009 Update On Paxil Lawsuits Alleging Birth Defects
Reports About Paxil Cases In Boston, Philadelphia, And Mississippi (Posted by Tom Lamb at DrugInjuryWatch.com) To set the stage we start back in December 2005, when the FDA issued a News Release titled "FDA…