Tag: label change
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Yasmin / Safyral / Beyaz: February 2012 Label Change Non-Specific To These Bayer Birth Control Pills
Same General Warning About All COCs Was Added To YAZ In March 2011; And Why The One Year Delay, We Wonder (Posted by Tom Lamb at DrugInjuryWatch.com) The February 14, 2012 email captioned "What's New…
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Multaq: August 2011 Update: Another Liver Failure Case Report Article In Medical Journal
New Sanofi "Dear Doctor" Letter: Label Change Regarding Heart-Related Side Effects Coming Soon (Posted by Tom Lamb at DrugInjuryWatch.com)This August 2011 update on Multaq (dronedarone) covers both liver injury and cardiovascular side effects. The medical…
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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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Chantix Anti-Smoking Pill: How Significant Is The Heart Risk; Should Chantix Be Recalled
Canadian Medical Journal Article Suggests That The June 2011 Label Change By FDA And Pfizer Is Not Sufficient Measure (Posted by Tom Lamb at DrugInjuryWatch.com) As some may recall, in mid-June 2011 the FDA issued…
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Another Rather “Odd” YAZ Label Change By Bayer: March 2011
Provides New Warnings About Certain Side Effects As Regards ALL Birth Control Pills (Not Specific To YAZ) (Posted by Tom Lamb at DrugInjuryWatch.com) The bottom line is this: There is nothing specific about YAZ…
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Zithromax Label Adds Warning About Drug-Induced Liver Injury In February 2011
Adverse Reactions And Warnings Sections Now Include Hepatotoxicity, From Hepatic Dysfunction To Liver Failure (Posted by Tom Lamb at DrugInjuryWatch.com) The association between the antibiotic Zithromax (azithromycin) and drug-induced liver failure first received some real…
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Zocor Label Change: Interstitial Lung Disease (ILD) Added As Possible Adverse Reaction
November 2010 FDA Approval Of Merck Action Raises Profile Of This Emerging Drug Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported recently, the October 2010 issue of the Canadian Adverse Reaction…
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Diabetes Drug Byetta Linked To Kidney Problems And Cases Of Renal Failure
October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2009 the Drug Safety Update Newsletter alerted us about reports of kidney-related…