Tag: safety review
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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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YAZ / Yasmin: December 2011 FDA Advisory Committees Meeting Background Materials Now Available Online
Expert Reports From YAZ / Yasmin Lawsuits Will Not Be Considered Because Submitted After Deadline Set By FDA (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: "Bayer Birth Control Pill Benefits Outweigh Risks, Panel…
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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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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…