Category: FDA Drug Safety Oversight
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FDA’s Delayed Announcement About Possible Insulin Overdoses Due To Recalled Syringes
Tyco Healthcare Group LP (Covidien) Recall Of ReliOn Disposable Syringes Was First Announced October 9, 2008; FDA Press Release About This Syringe Recall Is Dated November 5, 2008 (Posted by Tom Lamb at DrugInjuryWatch.com)…
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Possible Avandia Recall: Liver Failure Cases May Tip Balance Of Risk vs. Benefit
October 2008 Public Citizen Petition Wants Glaxo's Diabetes Drug Banned Due To "New" Side Effect, Liver Toxicity (Posted by Tom Lamb at DrugInjuryWatch.com) On October 30, 2008 Public Citizen's Health Research Group (HRG) submitted a…
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FDA Wants To Change Its MedWatch Adverse Event Reporting System
October 2008 Federal Register: FDA Seeks Public Comments On A New MedWatch Portal; December 22 Deadline (Posted by Tom Lamb at DrugInjuryWatch.com) According to a Notice in the October 23, 2008 edition (Volume 73, Number 206)…
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A New “Double-Dose” Pill Drug Recall Is Issued By ETHEX Corp.
First It Was Their Morphine Tablets; Now ETHEX Dextroamphetamine 5mg Pills May Be Oversized And Contain Two Times The Active Ingredient (Posted by Tom Lamb at DrugInjuryWatch.com) By means of an October 16, 2008…
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Congress Will Investigate Digitek Recall And What FDA Knew About Actavis Manufacturing Problems
After Earlier Class 1 Recall Of Digitek, All Acvtavis Drugs Manufactured At Its Little Falls, NJ Plant Were Recalled In August 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 8, 2008 Representatives John…
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FDA Alerts Doctors That Revlimid Can Cause Serious Skin Reactions In Patients
Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, And Erythema Multiforme Are Associated With Revlimid Use (Posted by Tom Lamb at DrugInjuryWatch.com) The Summer 2008 edition of the US FDA's Drug Safety Newsletter included an article concerning Revlimid…
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FDA: Tequin Was Withdrawn From U.S. Market “For Reasons Of Safety Or Effectiveness”
Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin (Posted by Tom Lamb at DrugInjuryWatch.com) On September 2, 2008 the FDA issued a Notice entitled "Determination…
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FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility
Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills (Posted by Tom Lamb at DrugInjuryWatch.com) There is yet another apparent quality-control problem…
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August 2008: FDA Issues Its Final Version Of A New Rule Which May Give Complete Immunity To Drug And Medical Device Companies
FDA Rule Could Serve To Defeat Lawsuits Alleging Failure To Warn About Potentially Harmful Effects Of Prescription Drugs And Medical Devices (Posted by Tom Lamb at DrugInjuryWatch.com) Back in February 2008, in a post titled,…
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Senators Kennedy And Leahy Introduce Legislation To Protect Patients From Dangerous And Defective Devices
August 2008 Senate Counterpart of HR 6381, Medical Device Safety Act 2008, Which Was Sponsored By Congressmen Waxman And Pallone (Posted by Tom Lamb at DrugInjuryWatch.com) In a June 27, 2008 article, "Newly Introduced…