Category: FDA Drug Safety Oversight
-
Tequin Revisited: Health Canada And The FDA Failed To Take Action, At Our Expense
Bristol-Myers Squibb Was Allowed To Withdraw Their Unsafe Drug For "Economic Reasons", And Only After Selling Off Its Inventory (Posted by Tom Lamb at DrugInjuryWatch.com) An article by Joel Lexchin, MSc MD, "Information about…
-
Sprint Fidelis Recall Showed That FDA’s Medical Device Safety System Is Flawed
Dr. Hauser: "Just because a device is FDA-approved does not necessarily mean it is safe." (Posted by Tom Lamb at DrugInjuryWatch.com) In his March 5, 2008 article — "Medical device safety in spotlight; M.D.…
-
Patient Lawsuits Against Pharmaceutical Companies For Drug Injuries Might Be Prohibited In U.S.
Our Tort System Provides A Needed Means Of Accountability; Law Professor: "A lot is lost without these lawsuits." (Posted by Tom Lamb at DrugInjuryWatch.com) On March 3, 2008 the U.S. Supreme Court issued its…
-
FDA Proposed Rule About Drug Label Warning Changes Will Lessen Agency’s Power To Protect Us
This January 2008 Rule Issued By FDA Is An Attempt To "End-Run" Congress And Lays The Groundwork For Another Unsafe Drug Debacle Like Vioxx (Posted by Tom Lamb at DrugInjuryWatch.com) On January 16, 2008…
-
Dr. Dennis Mangano Says On 60 Minutes In February 2008 That Trasylol Should Have Been Recalled As Early As January 2006
Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report (Posted by Tom Lamb at DrugInjuryWatch.com) According to interviews broadcast by CBS Television’s 60…
-
Medications Used For Epilepsy And Bipolar Disease Can Increase Risk Of Suicide And Suicidal Ideation
FDA Will Convene Advisory Committee Meeting To Consider Whether Anti-Epileptic Drugs, Or Perhaps Epilepsy Itself, Associated With Increase In Suicidal Behaviors (Posted by Tom Lamb at DrugInjuryWatch.com) On January 31, 2008 the FDA issued…
-
Subpoenas Issued For Witnesses To Appear At February 2008 U.S. House Committee Hearing On Ketek
Congress Wants To Know When Sanofi-Aventis And The FDA Learned About Fraud Involved With Ketek Study 3014 (Posted by Tom Lamb at DrugInjuryWatch.com) Soon after noon on January 29, 2008 Ed Silverman posted on…
-
The FDA Aims To Improve Its Detection Of Drug Safety Signals
Public Workshop On January 29, 2008 To Focus On Adverse Drug Reaction Reporting (Posted by Tom Lamb at DrugInjuryWatch.com) In recent years the FDA has been roundly criticized for its failure to timely recognize…
-
Reports Of Tendon Ruptures Caused By Antibiotics Levaquin, Cipro, And Avelox
Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) ____________________________________________________________________ UPDATE: For recent developments regarding personal injury lawsuits that involve…
-
Senator Grassley’s December 2007 Letter To FDA Questions Agency’s Approval Of Ketek
Sanofi-Aventis Antibiotic Has Been Subject Of Controversy Since Reports of Liver Damage Surfaced In Early 2006 (Posted by Tom Lamb at DrugInjuryWatch.com) The safety concerns about Ketek (telithromycin) began in early 2006 after Health…