Tag: drug-induced liver injury
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Tavneos Liver Risks Confirmed by Medical Registry Data in the US
Possible Legal Compensation Cases for People Who Developed Tavneos Liver Injury (Posted by Tom Lamb at Drug Injury Watch) The FDA approved Tavneos (avacopan) in 2021 to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV). We had been…
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Drug-induced Liver Injury: Guidelines for Diagnosing and Managing Patients Updated in 2021
American College of Gastroenterology Requested a Group of Experts to Develop New Guidelines for DILI (Posted by Tom Lamb at Drug Injury Watch) This medical journal article, "ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic…
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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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Risk Of Actemra Associated Liver Injury Being Assessed By Health Canada, With Drug Label Change Likely To Follow
Drug-Induced Liver Injuries Reported In Patients Using Actemra, Including Cases Of Acute Liver Failure Requiring A Transplant (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2019 we learned that Actemra has been…
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Ocaliva Black-Box Warning About Liver Failure Due To Incorrect Doses Added In Early 2018
This Ocaliva Label Change Follows September 2017 Dear Doctor Letter Sent By Intercept Pharmaceuticals (Posted by Tom Lamb at DrugInjuryWatch.com) An earlier blog post, "Will Ocaliva Get Black-Box Warning For Liver Injury…
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2018 Emerging Drug Litigations: Mirena IUD and Ocaliva
Additional information concerning the potentially harmful side effects of the Mirena IUD and Ocaliva was released over the course of 2017, and we will continue to monitor the situation in 2018.
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Drug-Induced Liver Injury Warning Added To OFEV Label In Canada As Done Earlier In US
This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators (Posted by Tom Lamb at DrugInjuryWatch.com) OFEV (nintedanib) capsules were approved by the FDA in 2014…
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FDA Recommends A Recall For Limbrel “Medical Food” Product But Primus Pharmaceuticals Is Not Complying
Reports Of Drug-Induced Liver Injury And Hypersensitivity Pneumonitis Are At Center Of This Unusual Drug Safety Controversy (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Primus Pharmaceuticals Inc. Finally Removes Its Osteoarthritis Capsule Limbrel…
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Hepatitis C Drugs Viekira Pak And Technivie Require Warnings Label Changes Due To Liver Injury Reports
FDA Says The Timing Of Liver Injury Suggests That These Are Side Effects, Especially In Patients With Advanced Cirrhosis (Posted by Tom Lamb at DrugInjuryWatch.com) Viekira Pak and Technivie are relatively new…
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Xarelto: Drug-Induced Liver Injury Reports Received By Health Canada And Found In Medical Literature
Should New Liver Side Effects Warning Be Added By Janssen Pharmaceuticals To Prescribing Information For Xarelto? (Posted by Tom Lamb at DrugInjuryWatch.com) In the August 2015 edition of the Health Product InfoWatch…