Tag: FDA
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2012 FDA Report On Beyaz Points Out That Younger Women and Girls Are Most At-Risk For Blood Clots
Approved By FDA In 2010, There Has Been No Study Done Yet Regarding Beyaz Safety — Despite Significant Number Of Beyaz Adverse Event Reports (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: FDA Meeting…
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Epogen / Procrit / Aranesp: The July 2012 News Report Which Tells Story Of Big Pharma Profits Over Patient Safety And Drug Efficacy
Once The FDA Started Paying Attention The Writing On The Wall Became Apparent, Albeit Too Late For Some (Posted by Tom Lamb at DrugInjuryWatch.com) This lengthy and well-presented news report, "Anemia drugs made billions, but…
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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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Merck Funded Study Says There Is No Blood Clot Risk With NuvaRing, While BMJ Medical Journal Article Reports A 90% Increased Risk
Perhaps These Conflicting Findings As Regards Serious NuvaRing Side Effects (PE, DVT, Stroke) Will Prompt FDA To Convene An Advisory Committee Meeting To Consider Safety Of This Vaginal Ring (Posted by Tom Lamb at DrugInjuryWatch.com) Some conflicting and…
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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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April 2012 Yasmin / YAZ Label Change: FDA Warns About Increased Risk Of Blood Clots Possible Due To Drospirenone
Beyaz, Safyral, Ocella, Gianvi, Zarah, Loryna, Syeda, And Vestura OC Pills Contain DRSP Progestin Also (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Bayer's "Dear Doctor" Letter about April 2012 label change (PDF) for its…
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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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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…