Tag: European Union
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Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.
Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There — Why Not Here, Too (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: This label revision regarding hemophilia…
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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…
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Should Meridia Remain On Market? FDA Says “Yes” (For Now At Least), European Drug Regulators Say “No”
Difference Of Opinion Suggests There Could Be A Possible Meridia Recall In U.S. Before The FDA Holds Its Public Advisory Meeting In September 2010(Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Abbott Pulls Meridia in U.S. Amid…