Tag: liver transplant
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Gilenya Liver Injury Risk Warnings Are Increased, Again, This Time in Canada
Similar Gilenya Drug Label Changes Were Made in Europe and UK During Past Few Months (Posted by Tom Lamb at Drug Injury Watch) On January 18, 2021 Health Canada posted a Gilenya…
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Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant
European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change (Posted by Tom Lamb at DrugInjuryWatch.com) A recent periodic review of Gilenya safety data by the European Medicines…
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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-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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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…