Tag: European Medicines Agency
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Meningioma Warning For Depo-Provera Recommended in Europe by Drug Regulator
Why Has This September 2024 European Medicines Agency (EMA) Action Not Been Followed by FDA in US? (Posted by Tom Lamb at Drug Injury Watch) One of the primary issues in the increasing number of Depo-Provera meningioma…
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Syfovre Safety-Benefit Assessment by Europe’s Drug Regulator Differs From FDA
EMA’s CHMP Does Not Approve Syfovre for a Second Time, Citing "significant risk of adverse events" (Posted by Tom Lamb at Drug Injury Watch) There seems to be some disagreement about the Syfovre safety-benefit assessment…
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JAK Inhibitors Safety Review by European Drug Regulator EMA Announced in February 2022
Xeljanz, Rinvoq, and Olumiant as Treatments for Inflammatory Disorders Have Been Under Scrutiny by FDA in the US (Posted by Tom Lamb at Drug Injury Watch) In December 2021 there was a notable JAK inhibitors…
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Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant
European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change (Posted by Tom Lamb at DrugInjuryWatch.com) A recent periodic review of Gilenya safety data by the European Medicines…
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Picato May Increase The Risk Of Skin Cancer As Side Effect, Says Drug Regulator Health Canada In July 2020
Picato Skin Cancer Risk Has Been Confirmed By European Drug Regulator; The FDA Is Still Investigating This Picato Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) The topical gel drug Picato (ingenol…
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Gilenya Birth Defects Warnings Issued By Drug Safety Regulators In Canada And Europe — But Not By FDA In The US
Gilenya Increased Risk of Major Congenital Malformations Such As Renal / Kidney And Musculoskeletal Abnormalities, Atrial Septal Defects (Posted by Tom Lamb at DrugInjuryWatch.com) On December 19, 2019 Health Canada issued a…
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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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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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European Drug Regulator EMA Suspends Use Of MRI Drugs Magnevist, Omniscan, And OptiMARK In July 2017
The Drug Safety Concern Is That Use Of These Gadolinium Contrast Agents Can Leave Gadolinium Deposits In Brain Tissues (Posted by Tom Lamb at DrugInjuryWatch.com) The European Medicines Agency (EMA) recently announced…
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European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New “Hep-C” Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation
These Relatively Recent Direct-Acting Antivirals Are Increasingly Popular For Treating Chronic Hepatitis C, But There Could Be Serious Side Effects In Addition To The High Costs (Posted by Tom Lamb at DrugInjuryWatch.com) …