fda drug safety oversight

Yasmin / Safyral / Beyaz: February 2012 Label Change Non-Specific To These Bayer Birth Control Pills

Tom Lamb
February 29, 2012 16:47

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 on the FDA Drugs Site" let us know that there was a new version of the Package Insert for Yasmin,...

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

Tom Lamb
January 31, 2012 18:07

"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...

YAZ / Yasmin January 2012 Update: Minutes And Transcripts For FDA Advisory Committees 2011 Meeting Now Available Online (And More)

Tom Lamb
January 31, 2012 12:44

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, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk...

YAZ / Yasmin / Ocella: FDA Study Suggests An Increased Risk Of Blood Clots That Can Cause Side Effects Like Pulmonary Embolism

Tom Lamb
October 17, 2011 12:28

Early Results Suggest An Approximately 1.5-fold Increase In The Risk For Birth Control Pills With Drospirenone (DRSP) (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ Yaz Birth Control Investigation Nightline from ABC News (video)...

September 2011: Two FDA Advisory Committees Will Discuss The Safety Of Long-Term Use Of Fosamax, Boniva, And Actonel

Tom Lamb
October 14, 2011 16:42

Osteonecrosis Of The Jaw, Or Jawbone Death, And Atypical Femur Fractures, Or Low-Stress Thigh Bone Breaks, Are The Primary Drug-Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Warner, Merck Bone Drugs...