Category: FDA Drug Safety Oversight
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Pradaxa: 2012 Label Revisions In The U.S. And Canada, Where A “Dear Doctor” Letter Was Sent Out
New Case Report About Routine Fall Involving An Elderly Patient That Results In Fatal Irreversible Brain Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription…
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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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Pneumonia Trial Of Janssen / J&J Antibiotic Doribax Was Stopped In May 2011 — We Learn From The FDA In January 2012
"Significant Safety Concern": Higher Death Rate For Doribax In Ventilator-Associated Pneumonia When Compared To Patients Receiving Imipenem Therapy (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Doribax (doripenem for injection) – Higher Mortality Rate and…
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YAZ / Yasmin January 2012 Update: Minutes And Transcripts For FDA Advisory Committees 2011 Meeting Now Available Online (And More)
11 Of The 26 FDA Panel Members Voted There Were No Sufficient Unique Benefits For YAZ / Yasmin That Cannot Be Found In Other Hormonal Contraceptives (Posted by Tom Lamb at DrugInjuryWatch.com)On December 8,…
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Safety Profile Of New Stroke Drug Pradaxa Has Been Tarnished By Various Adverse Event Reports
FDA Reviewing Serious Side Effects Associated With Pradaxa Ranging From Heart Attacks To Serious Bleeding or Hemorrhages (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Pradaxa label change: This January 17, 2012 FDA approval letter shows…
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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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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…