Drug Injury Watch

Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings

Published on 2012-02-10 12:38:00

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 article "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals". Our source back then and now, for this 2012 update, is the ISMP Quarterwatch publication, which monitors FDA MedWatch Reports for emerging drug safety issues. Fr

Gianvi Lawsuits Against The Drug Companies Still Possible After 2011 Supreme Court Preemption Ruling Re: Generic Drug Injury Lawsuits

Published on 2012-02-06 16:17:59

Reason Is That Bayer Has Been Supplying Teva And Barr With The Product For Their Gianvi Pills Since December 2010 (Agreement Is Similar To Ocella Deal) (Posted by Tom Lamb at DrugInjuryWatch.com) Gianvi, a generic version of YAZ, is marketed by Teva Pharmaceuticals and Barr Laboratories, which are commonly referred to as generic drug companies. Likewise, Ocella is a generic version of Yasmin that is sold by Teva and Barr. Unfortunately, most women who used the Gianvi birth control pills and suff

Pneumonia Trial Of Janssen / J&J Antibiotic Doribax Was Stopped In May 2011 -- We Learn From The FDA In January 2012

Published on 2012-01-30 16:06:00

"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 a Lower Clinical Cure Rate Observed During a Comparative Clinical Trial - Notice to Hospitals" [Health Canada, 1/31/12] The product monogr