Tag: “Black-Box” warning
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Prolia Increased Risk Of Hypocalcemia In Patients With Chronic Kidney Disease (CKD) Can Be 20-Times Higher Than Pills
Prolia "Black Box" Warning: Harm From Severe Hypocalcemia Ranges From Hospitalization For Life-threatening Events To Death (Posted by Tom Lamb at Drug Injury Watch) A January 2024 JAMA Original Investigation article, "Severe Hypocalcemia With Denosumab…
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Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer
One wonders how the FDA might react to this continued “direct to consumer” advertising for Xeljanz which Pfizer is (still) sponsoring after the February 2021 FDA Xeljanz Drug Safety Communication about Xeljanz causing heart…
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Xeljanz Warning For Increased Risk Of Blood Clots And Death With Higher Dose Used For Ulcerative Colitis
"Black Box Warning" For Xeljanz 10 mg Twice Daily Dose Required By FDA In July 2019 Follows Regulatory Action In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) A Xeljanz FDA Drug Safety…
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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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Uloric Recall, “Black-Box Warning”, And Limited Use Discussed By FDA Advisory Committees In January 2019
Despite Drug Safety Problem Of Cardiovascular Mortality, Benefits Might Be Seen To Outweigh Risks For Select Gout Patients (Posted by Tom Lamb at DrugInjuryWatch.com) Uloric (febuxostat) was approved by the FDA in…
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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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Ocaliva Black-Box Warning About Liver Failure Due To Incorrect Doses Added In Early 2018
This Ocaliva Label Change Follows September 2017 Dear Doctor Letter Sent By Intercept Pharmaceuticals (Posted by Tom Lamb at DrugInjuryWatch.com) An earlier blog post, "Will Ocaliva Get Black-Box Warning For Liver Injury…
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Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report?
19 Patients Have Died While Using This New Liver Disease Drug, Some When Prescribed Higher-Than-Recommended Doses (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: “FDA adds Boxed Warning to highlight correct dosing of Ocaliva…
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For Testosterone Therapy Drugs Like AndroGel / Axiron / Testim: Add “Black-Box” Warning To Label: Public Citizen’s Petition To FDA
Earlier In February 2014 The Endocrine Society Of Medical Doctors Urged Caution In The Prescribing Of These Products To Certain Middle-Aged And Older Men (Posted by Tom Lamb at DrugInjuryWatch.com)On February 25, 2014 a so-called Citizen Petition…
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Flomax Can Cause Severe Hypotension According To A New Medical Study Article Published In November 2013 BMJ Journal
Low Blood Pressure Can Lead To Loss Of Consciousness / Fainting With A Fall Down Resulting In Injury And Hospital Admission (Posted by Tom Lamb at DrugInjuryWatch.com) Flomax® (tamsulosin) received its initial FDA approval…