Tag: FDA
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Ortho Evra: December 2011 FDA Advisory Committees Meeting Background Materials Now Available Online
J&J Birth Control Patch Ortho Evra Safety Review Will Focus On Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Transcript for…
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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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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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Two More Medical Studies Show Increased Risk Of Blood Clots With Use Of YAZ, Yasmin, And Ocella
Researchers Find Drospirenone (DRSP) Containing Birth Control Pills Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (Posted by Tom Lamb at DrugInjuryWatch.com) New research published online in October 2011 by the…
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YAZ / Yasmin / Ocella: FDA Study Suggests An Increased Risk Of Blood Clots That Can Cause Side Effects Like Pulmonary Embolism
Early Results Suggest An Approximately 1.5-fold Increase In The Risk For Birth Control Pills With Drospirenone (DRSP) (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: YAZ / Yasmin / Ocella Update: October 2011 FDA…
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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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Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling
Generic Drug Companies Should Have To Update Side Effect Warnings Or Face Drug Injury Lawsuits (Posted by Tom Lamb at DrugInjuryWatch.com) On August 29, 2011 the consumer advocacy group Public Citizen took action in…
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Reports Of Male Breast Cancer Associated With The Use Of Propecia And Proscar
Recent Label Change For These Drugs Made In Canada But Not In U.S., Yet (Posted by Tom Lamb at DrugInjuryWatch.com)On August 4, 2011 Health Canada issued this Information Update, "Finasteride (Propecia, Proscar): Potential rare risk…
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YAZ / Yasmin / Ocella / Beyaz / Safyral: Drug Safety Regulators Focus On Blood Clot Side Effects
EMA Orders New Warning About Risk Of Venous Thromboembolism, While FDA And Health Canada Begin Safety Review (Posted by Tom Lamb at DrugInjuryWatch.com) In recent months there has been a flurry of activity by…
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Multaq Update: European Safety Review Expanded To Cardiovascular Side Effects Risk In July 2011
EMA And FDA Already Had Sanofi Issue A "Dear Doctor" Letter About Liver Failure In January 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA announced on July 21, 2011 that it…