Category: FDA Drug Safety Oversight
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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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Actemra Side Effects: Pulmonary Hypertension, Interstitial Lung Disease, Pulmonary Alveolar Proteinosis
FDA Watch List Includes Actemra: Evaluating Regulatory Action Based On Possible Signs Of Serious Risk, New Safety Information (Posted by Tom Lamb at DrugInjuryWatch.com) In July 2018 the FDA issued this document,…
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Bayer: Essure Permanent Birth Control Device Removal From US Market Is “Business Decision”
Or Is This Really An Essure Recall Due To High Numbers Of Adverse Events Reported To FDA And Related Essure Lawsuits (Posted by Tom Lamb at DrugInjuryWatch.com) We have reported developments concerning…
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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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Gadolinium Toxicity Risks Higher For Children, Pregnant Women, And People Receiving Multiple Doses
Gadolinium Deposition Disease And Neurological Adverse Reactions Associated With The Use Of Gadolinium-Based Contrast Agents (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2018 Health Canada announced the results of its second…
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Gout Drug Uloric Recall By FDA Requested In June 2018 Public Citizen Petition Letter
Consumer Group Contends That The Evidence Of Harmful Uloric Side Effects Outweighs Any Real Benefit To Patients (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA should order Takeda Pharmaceuticals to immediately withdraw from…
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Gadolinium Retention Warnings Added To Drug Labels For Gadolinium Contrast Agents Used During MRI / MRA
Label Changes Announced By FDA In December 2017 Finally Approved For Magnevist, Omniscan, And Other GBCAs In April 2018 (Posted by Tom Lamb at DrugInjuryWatch.com) Gadolinium based contrast agents (GBCAs) are substances…
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DPP-4 Diabetes Drug Side Effects Include Heart Attacks And Strokes As Well As Heart Failure
Onglyza, Nesina, Januvia, and Tradjenta Are Included In This Popular Class Of Type-2 Diabetes Medications (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2016 the FDA took regulatory action by mandating label…
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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…