Tag: 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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Tavneos Liver Injury Drug Safety Communication Issued by FDA in Late March 2026
Just 2 Months Earlier, Amgen Refused an FDA Request to Withdraw Tavneos; Will There Be a Tavneos Recall Soon? (Posted by Tom Lamb at Drug Injury Watch) On March 31, 2026, the FDA issued a Tavneos liver…
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Veozah Liver Injury Drug Safety Communication Issued by FDA in September 2024
August 2024 Veozah Drug Label Change Adds Warnings About Liver Toxicity and Abnormal Liver Tests (Posted by Tom Lamb at Drug Injury Watch) UPDATE: January 2025 Dear Healthcare Professional letter sent by Astellas Pharma Ltd. in…
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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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June 2019 Actemra Label Change Adds Warnings About Increased Risks Of Liver Injury After Months Or Years Of Use
Serious Cases Of Hepatic Injury Some Of Which Have Resulted In Liver Transplant Or Death Reported As Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On May 21, 2019 we posted this…
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Pradaxa-Related Liver Injury: Health Canada’s Drug Safety Review Of Pradaxa Concludes There Is A Link
Remains Unknown Whether Pradaxa Label Change About Liver Damage In Canada Will Be Followed By Similar FDA Action In US (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2018 Health Canada announced…
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Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report?
19 Patients Have Died While Using This New Liver Disease Drug, Some When Prescribed Higher-Than-Recommended Doses (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: “FDA adds Boxed Warning to highlight correct dosing of Ocaliva…
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Multiple Sclerosis Drug Tecfidera: FDA Mandates January 2017 Label Change Which Adds Warnings About Liver Injury Cases
Besides Hepatotoxicity, Progressive Multifocal Leukoencephalopathy, Renal Toxicity, And Other Safety Issues Have Surfaced Since Clinical Trials (Posted by Tom Lamb at DrugInjuryWatch.com) Tecfidera (dimethyl fumarate) was approved by the FDA in 2013…