Tag: FDA
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Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible
Serious Side Effects For Xeljanz 10 mg Dose Found In Pfizer Post-Marketing Study Leads To New European Drug Safety Regulatory Action (Posted by Tom Lamb at DrugInjuryWatch.com) The serious side effects associated…
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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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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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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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Newer Diabetes Drugs Side Effect: Fournier’s Gangrene, Serious Infection Of Genital Area
FDA Mandates Label Changes With New Warnings For Invokana, Farxiga, Jardiance, Other SGLT2 Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) In late August 2018 the FDA warned doctors and patients that cases…
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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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Rexulti Warnings For Compulsive Behavior And Impulse Control Problems Added To Drug Label
FDA: Patients Using Rexulti At Risk For Experiencing Intense Urges For Gambling And Inability To Control Conduct (Posted by Tom Lamb at DrugInjuryWatch.com) Rexulti® (brexpiprazole) was initially approved by the FDA in…
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Number Of Nuplazid Patient Deaths Reported To FDA In Just The Past Two Years Causes Alarm In Drug Safety Circles
This Relatively New Parkinson’s Disease Drug Already Been Implicated In Hundreds Of Death Cases, While Only Being On Market Since 2016 (Posted by Tom Lamb at DrugInjuryWatch.com) Two years ago the FDA…
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Uloric Drug Safety Update: A Significantly Higher Risk Of Death Among Patients Using Gout Drug Uloric As Opposed To Allopurinol
Recent Findings Come From The CARES Trial, A Postmarketing Safety Study Requested By FDA Back When Uloric Was Approved In 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) At the recent American College…