Tag: CHMP
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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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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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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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Avandia Recall Decision In Europe To Be Announced On Or About September 23, 2010
Will This September 2010 EMA Committee Meeting Result In A Consensus, Unlike July 2010 FDA Avandia Panel Voting (Posted by Tom Lamb at DrugInjuryWatch.com) _______________________________________________________________________ UPDATE: FDA Keeps Diabetes Pill on Market; Europe Suspends Sales …
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March 2010: Bayer Says It Will Update Yasmin Label In Europe To Add Results From Four Medical Studies
Two Newer Studies Found An Increased Venous Thromboembolism (VTE) Risk in Yasmin Users Compared To Levonorgestrel-Containing Birth Control Pills (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________________________________________________________________ UPDATE: New research suggests that women who use oral…