Category: FDA Drug Safety Oversight
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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 Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients
EMA Will Investigate Reports Of Associated Conditions Beyond Those That Were In November 2018 FDA Drug Safety Communication (Posted by Tom Lamb at DrugInjuryWatch.com) We recently learned by means of this April…
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Zelnorm Approved By FDA (Again) In 2019 – Despite Zelnorm Being Removed From Market In 2007 For Safety Concerns
Concerns About Potential Cardiovascular Safety Signal As Well As Suicidal Ideation And Behavior Were Involved With Zelnorm Recall (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2018 we wrote this article, “Waiting…
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Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism
FDA Is Reviewing Safety Of Xeljanz 10 mg Twice-Daily Dose Of This JAK Inhibitor, According to February 2019 News Reports (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: FDA Drug Safety Communication: "Safety…
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There Is A Warning About Increased Risk Of Lower Limb Amputations For Invokana And Invokamet (Only)
Going Into 2019 The Issue Of These Amputations Being An SGLT2 Inhibitors Drug Class Side Effect Remains Open To Debate (Posted by Tom Lamb at DrugInjuryWatch.com) A year-and-a-half ago we wrote this…
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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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Farxiga And Jardiance Are Associated With Twofold Increased Risk For Lower Limb Amputations
November 2018: The BMJ Medical Journal Publishes New SGLT2 Diabetes Drug Observational Study (Posted by Tom Lamb at DrugInjuryWatch.com) Diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) inhibitors class are associated with…
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CoaguChek XS PT Test Strips: Roche Devices For Blood Thinner INR Measurement – Urgent FDA Recall November 2018
More Than 1 Million Packages Of Defective Devices Used To Check INR For Warfarin May Cause Serious Injuries Or Death (Posted by Tom Lamb at DrugInjuryWatch.com) In September 2018 Roche Diagnostics issued…
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Waiting To See Whether FDA Approves Zelnorm In 2018 After Zelnorm Was Withdrawn In 2007 For Safety Reasons
Earlier Zelnorm Recall Was Due To Potential Cardiovascular Safety Signal, With Suicidal Ideation And Behavior Being Another Issue (Posted by Tom Lamb at DrugInjuryWatch.com) On October 17, 2018 the FDA’s Gastrointestinal Drugs…