Category: FDA Drug Safety Oversight
-
Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions
While Doctors And Hospitals Handle Patients Having Serious Bleeding Events From Pradaxa, The Drug Company Along With The FDA Still Say All Is Fine, Here (Posted by Tom Lamb at DrugInjuryWatch.com) There was a flurry of activity in the…
-
New Obesity Drug Qsymia / Qsiva Gets Gets Negative Opinion By European Medicines Agency (EMA)
Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) On October 18, 2012 European drug regulators…
-
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…
-
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…
-
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…
-
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…
-
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…
-
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…
-
March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling
One Year After The Hearing In Pliva v. Mensing, Some Momentum Builds For (Once Again) Allowing Drug Injury Lawsuits On All Prescription Medications, Generic As Well As Brand Name (Posted by Tom Lamb at…