Tag: EMA
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Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe
January 2020 News Report: FDA “is gathering data and information to investigate the safety concern related to Picato” (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: The UK’s Medicines and Health products Regulatory…
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European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)
Recommends That Xeljanz Should Be Used With Caution In Patients At High Risk Of Blood Clots As Well Aa In Patients Older Than 65 Years Of Age (Posted by Tom Lamb at DrugInjuryWatch.com)…
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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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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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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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Diabetes Medicine Invokana Gets New Warning About Lower Limb Amputation Added To Drug Package Insert In Canada
This December 2016 Label Change Mandated By Health Canada, However, Does Not Apply To Jardiance, Farxiga, And The Rest Of SGLT2 Inhibitors Class Of Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE:…
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Summer 2016 Update On Diabetes Medicines Invokana / Farxiga / Jardiance: Drug Label Changes And Safety Investigations
According To Drug Regulators, New Possible Side Effects Include: Fatal Cases Of Ketoacidosis; Leg, Foot, And Toe Amputations; And, Lactic Acidosis (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Invokana “Black-Box Warning” For…
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Invokana Lawsuits Are Expected To Be Filed While FDA And Other Drug Regulators Investigate Side Effects Reports
Drug Injury Lawyers Also See Possible Farxiga And Jardiance Cases For Patients Who Have Ketoacidosis, Kidney Failure, Stroke, Or Heart Attack (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________ UPDATE: “Health Canada Warns About…
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Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya
ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical" (Posted by Tom Lamb at DrugInjuryWatch.com)The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for…
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European Medicines Agency (EMA) Committee Recommends Further Restrictions On Use Of Depakote / Depakene / Depacon By Women Of Childbearing Age
Cites Higher Risks Of Neural Tube Defects Like Spina Bifida, Hypospadias, And Other Birth Defects As Well As Increased Risk Of Autism Spectrum Disorder (Posted by Tom Lamb at DrugInjuryWatch.com)More restrictions of the use of valproate drugs…