Category: FDA Drug Safety Oversight
-
Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems
Serious Side Effects Include Heart Attacks, Abnormal Heart Rhythms, Heart Failure, And Various Conditions Caused By Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Xolair Is Associated With Higher Than Expected Reporting…
-
Some Of The Drospirenone (DRSP) Progestin Used In Yaz And Yasmin Pills May Have Been Of Bad Quality
August 2009 FDA Warning Letter Sent To Bayer Relates To Quality Control Problems Found In March 2009 At German Facility Where DRSP Was Made (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a…
-
Public Surveys Indicate The Need For Reform In Drug Safety By Big Pharma And The FDA
Healthcare Providers And Patients Are Encouraged To Report Adverse Events Involving Approved Or Unapproved Indications As Well As Medication Errors (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2006 Quintiles Inc., a leading CRO…
-
2006 Case Report Indicating That Xenical (Orlistat) May Cause Substantial Acute Liver Injury
Medical Journal Letter To Editor Stated That Exact Mechanism Of Hepatotoxicity In Subject Patient Was Unknown (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported, on August 24, 2009 the FDA issued its "Early…
-
FDA Conducts A Self-Critical Analysis Of Its Early Communications (ECs) Program
There Was Apparently A Brief Discussion About Effect Of ECs At July 2009 Agency's Drug Safety Oversight Board Meeting The Public Summary for the July 16, 2009 meeting of the FDA's Drug Safety Oversight…
-
Some Users Of Alli And Xenical Have Developed Serious Liver Injury Including Liver Failure
FDA Early Communication Makes Clear That No Definite Association Between Liver Injury And Orlistat Has Been Established At This Time (Posted by Tom Lamb at DrugInjuryWatch.com) On May 22, 2009 we first reported that…
-
Some Criteria To Determine A New Drug’s Potential For Causing Severe Drug-Induced Liver Injury (DILI)
In July 2009 FDA Issues Updated Guidance For Industry Document Concerning DILI In Premarketing Clinical Evaluation (Posted by Tom Lamb at DrugInjuryWatch.com) In July 2009 the FDA issued a Guidance for Industry document intended for pharmaceutical…
-
Diabetes Drug Avandia Associated With Liver Injury And Liver Failure, Again
July 2009 Medical Journal Article Follows 2008 Public Citizen's Petition For FDA To Ban Sales Of Avandia In U.S. (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2008 Public Citizen petitioned the FDA to…
-
Smoking Cessation Drugs Chantix, Wellbutrin, And Zyban Are Getting New “Black-Box” Warning
Will Warn About Risk Of Serious Neuropsychiatric Symptoms Including Agitation, Depression, Suicidal Thoughts, And Attempted Suicide (Posted by Tom Lamb at DrugInjuryWatch.com) On July 1, 2009 the FDA issued a Public Health Advisory about…
-
Merck’s Popular Asthma Drug Singulair Associated With Suicide And Depression
FDA Has Gone From "No Link" In January 2009 To Wanting An Increased Warning About These Neuropsychiatric Events In June 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) On June 12, 2009 the FDA announced…