Category: Drug Safety Alerts
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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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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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Current Use Of Cipro And Levaquin Associated With Increased Risk Of Detached Retina Eye Injury
Neither Recent Nor Past Use Of These Antibiotics In Fluoroquinolones Class Was Related To Retinal Detachment (Posted by Tom Lamb at DrugInjuryWatch.com) Patients taking oral antibiotics known as fluoroquinolones such as Cipro (ciprofloxacin) and…
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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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Pradaxa Bleeding Events: Four Major Factors Which Contributed To These Serious Side Effects
Prescriber Error, Impaired Renal Function, Patient Age, And Lack Of An Effective Reversal Agent Are Cited (Posted by Tom Lamb at DrugInjuryWatch.com) A Letter to The Editor, titled "Bleeding Risk with Dabigatran in the Frail…
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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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Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings
At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (Posted by Tom Lamb at DrugInjuryWatch.com) We first reported about Pradaxa (dabigatran) back in October 2011 in this…
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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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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…