Tag: drug safety
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Pradaxa Side Effects Update Mid-2012: Deaths, Hemorrhages, Acute Renal Failure, and Stroke Events Submitted To FDA MedWatch
Medical Journal Article Reports Pradaxa-Induced Rectal Bleeding And Hemostatic Disorder In Two Elderly Patients (Posted by Tom Lamb at DrugInjuryWatch.com) On May 31, 2012 the Institute for Safe Medication Practices (ISMP) released its 2011…
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The Victoza – Pancreatitis Issue: Some Related Developments From April 2011 To April 2012
A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease (Posted by Tom Lamb at DrugInjuryWatch.com) As regards the possible association between Victoza and pancreatitis as…
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Pradaxa Hemorrhage Cases May Occur In Oldest Patients Due To Age-Related Decline In Renal Function
QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug (Posted by Tom Lamb at DrugInjuryWatch.com) The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been…
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Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects
Adverse Event Reports For This New Blood Thinner Drug May Exceed Pre-Approval Clinical Trial Observations (Posted by Tom Lamb at DrugInjuryWatch.com) In early December 2011 the FDA announced it is evaluating reports of bleeding in…
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Another Generic YAZ Birth Control Pill Is Approved, Just One Week Before FDA Drug Safety Meeting
Coincidence, But Ironic, Given Several Recent Medical Studies Which Suggest Drospirenone (DRSP) Causes Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) On November 29, 2011 Watson Pharmaceuticals issued this press release, "Watson's Generic Yaz(R)…
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Safety Of Ortho Evra Birth Control Patch Will Be Subject Of FDA Advisory Committees Meeting
Possibly Increased Risk Of Blood Clot-Related Side Effects Like PE And DVT Suggested By Postmarketing Studies (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Ortho Evra: December 2011 FDA Advisory Committees Meeting Background Materials…
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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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Many Patients Mistakenly Believe That A Prescription Drug Must Be Safe If FDA-Approved
Safety Problems With New Medications Often Appear Only After Approval And Widespread Use (Posted by Tom Lamb at DrugInjuryWatch.com) A medical journal article published in the September 12, 2011 edition of the Archives of…
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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" …