Tag: EMA
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European Drug Safety Regulators Reviewing Hydroxyzine-Containing Medicines Such As Atarax And Vistaril For Heart Side Effects
Adverse Events Monitoring Data And Medical Studies Have Identified Possible Increased Risk For Cardiovascular Problems Including Arrhythmias (Posted by Tom Lamb at DrugInjuryWatch.com)In early May 2014 the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment…
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Byetta / Januvia / Victoza: Update On Possible Association Between These Newer Diabetes Drugs And Pancreatic Cancer As A Side Effect
Drug Safety Regulatory Developments And The Ongoing Academic Discussions About Provocative 2013 Medical Journal Article By Peter Butler At UCLA (Posted by Tom Lamb at DrugInjuryWatch.com)We last wrote about the possible association between pancreatic…
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New Obesity Drug Qsymia / Qsiva Gets Gets Negative Opinion By European Medicines Agency (EMA)
Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) On October 18, 2012 European drug regulators…
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Fall 2012: Two Recent Medical Reports Regarding Safety Of Pradaxa, Boehringer Ingelheim’s Anticoagulation Drug
Use Of Pradaxa After ACS Is Associated With Increased Rate Of Major Bleeding, And Concomitant Use Of Pradaxa With Multaq Is Contraindicated (Posted by Tom Lamb at DrugInjuryWatch.com) When Pradaxa (dabigatran) is used to prevent…
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Pneumonia Trial Of Janssen / J&J Antibiotic Doribax Was Stopped In May 2011 — We Learn From The FDA In January 2012
"Significant Safety Concern": Higher Death Rate For Doribax In Ventilator-Associated Pneumonia When Compared To Patients Receiving Imipenem Therapy (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Doribax (doripenem for injection) – Higher Mortality Rate and…
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European Medicines Agency (EMA) Recommends Multaq Use Should Be Restricted For Safety Reasons
EMA Cites The Increased Risks Of Liver Injury, Lung Side Effects, And Cardiovascular Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) In late September 2011 the European Medicines Agency (EMA) recommended that the use…
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Increased Risk Of Bladder Cancer Warning Added To Actos Label By Takeda Announced In August 2011
European Drug Regulator EMA Recommended New Actos Contra-Indications And Warnings In July 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: "European Medicines Agency clarifies opinion on pioglitazone and the risk of bladder cancer" …
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YAZ / Yasmin / Ocella / Beyaz / Safyral: Drug Safety Regulators Focus On Blood Clot Side Effects
EMA Orders New Warning About Risk Of Venous Thromboembolism, While FDA And Health Canada Begin Safety Review (Posted by Tom Lamb at DrugInjuryWatch.com) In recent months there has been a flurry of activity by…
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Multaq Cardiovascular Deaths Overshadow Earlier Liver Injury Concerns For Drug Regulators
FDA Now Looking At Two-Fold Increase In CV Deaths, Strokes, And Heart Failure Hospitalizations From PALLAS Study Data (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Multaq (dronedarone) – Information on Increase in Heart-Related…
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Multaq Update: European Safety Review Expanded To Cardiovascular Side Effects Risk In July 2011
EMA And FDA Already Had Sanofi Issue A "Dear Doctor" Letter About Liver Failure In January 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA announced on July 21, 2011 that it…