Tag: drug label changes
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Tavneos Warnings For VBDS Liver Side Effect Increased In April 2026
Tavneos Drug Label Change By Amgen Just 2 Days After Tavneos Drug Recall Statement By FDA (Posted by Tom Lamb at Drug Injury Watch) The Tavneos drug safety issue has an interesting new development. On April 29,…
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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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Uloric Lawsuits Involving Heart Attacks And Strokes Follow Recent FDA Warnings About Cardiovascular Deaths
February 2019 Uloric Label Changes Include New "Black-Box Warning" To The Effect That Uloric Is Gout Drug Of Last Resort (Posted by Tom Lamb at DrugInjuryWatch.com) As a result of recent FDA-mandated…
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Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label
Symptoms Developed Within Just One Day Of Lemtrada Injections, And Can Lead To Patient Death Or Permanent Disability Says FDA (Posted by Tom Lamb at DrugInjuryWatch.com) In late November 2018 this FDA…
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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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Invokana – Amputation Side Effect Gets “Black-Box Warning” On Revised Drug Label Issued In July 2017
This Label Change Was Previewed In A May 2017 FDA Drug Safety Communication About Increased Risk Of Leg And Foot Amputations (Posted by Tom Lamb at DrugInjuryWatch.com) A June 2017 article, “Invokana…
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FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors
This Follows October 2015 Safety Alert By Health Canada Concerning Increased Risks Of Kidney Problems (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada Warns About Link Between DKA & Popular Diabetes…
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August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect
These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________…
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Onglyza Update: FDA May Require A New Warning About Possible Increased Risk Of Heart Failure For Diabetes Drugs Onglyza And Kombiglyze XR
April 2015 FDA Advisory Committee Voted For An Onglyza Drug Label Change About Side Effects Risks, With One Panelist Voting Of An Onglyza Recall (Posted by Tom Lamb at DrugInjuryWatch.com) As previewed…
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Diabetes Drugs Bydureon And Victoza: Thyroid Cancer Label Change In March 2015 Comes Without Much Notice
FDA Letters To AstraZeneca And Novo Nordisk Approve Addition Of Information About Increased Risk For Medullary Thyroid Carcinoma (MTC) (Posted by Tom Lamb at DrugInjuryWatch.com) The diabetes drugs Bydureon (exenatide extended-release) for injectable suspension and Victoza (liraglutide…