Tag: “Black-Box” Warnings
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Eli Lilly Attempts to Distance Olumiant From the Ominous JAK Inhibitors Drug Class Safety Issues Flagged by FDA
Xeljanz, Rinvoq, and Olumiant Are the Three Janus Kinase (JAK) Inhibitors Getting "Black-Box" Warnings Revisions, Soon (Posted by Tom Lamb at Drug Injury Watch) In September 2021 the FDA announced it was requiring revisions to…
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Analysis Of FDA Adverse Event Reports Describes Extent And Nature of Invokamet / Invokana – Amputation Side Effect
This New Medical Research Was Published Just Before “Black-Box Warning” About Lower Limb Amputations Added To Drug Labels (Posted by Tom Lamb at DrugInjuryWatch.com) In the final week of July 2017, the…
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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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Harvoni, Sovaldi, Viekira Pak, And Other Direct-Acting Antivirals Get Black-Box Warning: Risk Of Hepatitis B Virus Reactivation
October 2016 FDA Drug Safety Communication Warns About These Relatively New Drugs Which Are Increasingly Popular For Treating Chronic Hepatitis C (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: “New Safety Issue:…
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The Essure Birth Control Product: Safety, Regulatory, And Legal Developments Over The Past Several Months
Increasing Number Of Women Who Have Allegedly Been Harmed By The Essure Inserts Have Filed Lawsuits Against Bayer (Posted by Tom Lamb at DrugInjuryWatch.com) Bayer’s Essure® product is a permanent birth control…
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Summer 2016 Update On Diabetes Medicines Invokana / Farxiga / Jardiance: Drug Label Changes And Safety Investigations
According To Drug Regulators, New Possible Side Effects Include: Fatal Cases Of Ketoacidosis; Leg, Foot, And Toe Amputations; And, Lactic Acidosis (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Invokana “Black-Box Warning” For…
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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…
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Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy
May 2013 Revised Depakote Drug Label Includes "Black-Box" And Warnings About These Congenital Malformations As Well As Decreased IQ Scores In Children (Posted by Tom Lamb at DrugInjuryWatch.com) As indicated below, in May 2013…