Tag: liver failure
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Zithromax Label Adds Warning About Drug-Induced Liver Injury In February 2011
Adverse Reactions And Warnings Sections Now Include Hepatotoxicity, From Hepatic Dysfunction To Liver Failure (Posted by Tom Lamb at DrugInjuryWatch.com) The association between the antibiotic Zithromax (azithromycin) and drug-induced liver failure first received some real…
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Sanofi-Aventis “Dear Doctor” Letter Will Warn Heart Drug Multaq Associated With Liver Failure
Liver Toxicity And Cardiac Side Effects Cause Dr. Steven Nissen To Express "concerns about the safety, efficacy and tolerability of dronedarone" (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Multaq "safety warning" issued by…
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Rheumatoid Arthritis Drug Arava Gets Increased Warning For Liver Injury In July 2010
The Bolded Warning About Severe Liver Problems Which Was Added In 2003 Is Replaced By "Black-Box" Warning (Posted by Tom Lamb at DrugInjuryWatch.com) On July 13, 2010 the FDA issued a MedWatch Alert about a new increased…
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Zithromax (Azithromycin) And Zmax Associated With Liver Failure And Pyloric Stenosis, Respectively
FDA Is Continuing To Evaluate These Emerging Drug-Safety Issues To Determine Whether Any Regulatory Action Is Needed (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-May 2010 we wrote an article "Zithromax-Induced Liver Injury Case…
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Zithromax-Induced Liver Injury Case Report Where There Was No History Of Liver Problems
Drug-Induced Liver Injury (DILI), Or Toxicity, Can Cause Both Acute And Chronic Liver Disease (Posted by Tom Lamb at DrugInjuryWatch.com) To get our bearings, we start with some points taken from the Abstract for the…
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FDA And Novartis Announce A Label Change For Iron Chelating Drug Exjade In Mid-February 2010
Includes A New "Black Box" Warning About Renal Impairment, Liver Failure, And Gastrointestinal Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-February 2010 the FDA and Novartis announced a change to the Prescribing Information…
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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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Some Users Of Alli And Xenical Have Developed Serious Liver Injury Including Liver Failure
FDA Early Communication Makes Clear That No Definite Association Between Liver Injury And Orlistat Has Been Established At This Time (Posted by Tom Lamb at DrugInjuryWatch.com) On May 22, 2009 we first reported that…
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Some Criteria To Determine A New Drug’s Potential For Causing Severe Drug-Induced Liver Injury (DILI)
In July 2009 FDA Issues Updated Guidance For Industry Document Concerning DILI In Premarketing Clinical Evaluation (Posted by Tom Lamb at DrugInjuryWatch.com) In July 2009 the FDA issued a Guidance for Industry document intended for pharmaceutical…
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Diabetes Drug Avandia Associated With Liver Injury And Liver Failure, Again
July 2009 Medical Journal Article Follows 2008 Public Citizen's Petition For FDA To Ban Sales Of Avandia In U.S. (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2008 Public Citizen petitioned the FDA to…