Category: FDA Drug Safety Oversight
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Court’s Riegel Preemption Ruling Would Be Negated With Bill Sponsored By Democrats In Congress
New Legislation Would Permit U.S. Patients To Sue Medical Device Companies If Product Caused Harm (Posted by Tom Lamb at DrugInjuryWatch.com) In the first part of June 2008 we learned that Representative Frank Pallone…
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Another “Double-Dose” Pill Problem Demonstrates How And Why The Digitek Recall Is So Unusual
June 2008 Drug Recall By ETHEX Is Similar To Digitek Recall, But Here The Drug Company Is Able To Provide Specific Information About Dates And Lot Numbers, Unlike Actavis (Posted by Tom Lamb at…
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Do Enbrel, Humira, Or Remicade Cause Cancer In Children And Young Adults?
FDA Will Conduct A Safety Review Of These TNF Blockers To Investigate This Possible Link (Posted by Tom Lamb at DrugInjuryWatch.com) On June 4, 2008 the FDA issued an "Early Communication About an Ongoing…
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June 2008 FDA Meeting Will Address Problem Of Look-alike And Sound-alike Drug Names
Confusion Between Similar Drugs Is A Cause Of Medication Errors That Agency Will Focus On In New Pilot Program (Posted by Tom Lamb at DrugInjuryWatch.com) To start, we get this background information from "Medication…
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Digitek Update May 2008: When Old News Is Better Than No News At All
A Month After FDA Class 1 Digitek Recall, We Have Been Told Little About Actavis Manufacturing Problem (Posted by Tom Lamb at DrugInjuryWatch.com) More than thirty days have passed since Actavis Totowa first announced…
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Actavis Tells Us More, But Not Much More, About April 2008 Digitek Recall
Actavis, Mylan, Or The FDA Should Tell Public Their Current Estimate Of How Many Defective Digitek Pills Were Distributed To Pharmacies, And During What Time Period (Posted by Tom Lamb at DrugInjuryWatch.com) On May…
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FDA Safety Evaluation Of Antibiotic Maxipime Is Not Completed, Yet
Six Months After It Announced Start Of This Investigation, FDA Gives An Update On Status Of Maxipime Safety Review (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-November 2007 the FDA announced the start of…
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May 2008 Update: Sprint Fidelis Lead Wire Failures Due To Design Flaw, Not Doctors
Medtronic Had Initially Suggested That It Was Implant Technique That Caused The Sprint Fidelis Malfunctions (Posted by Tom Lamb at DrugInjuryWatch.com) For today’s post we have to thank Westby G. Fisher, MD, FACC, who…
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Ortho Evra Recall Requested By Public Citizen Due To Blood Clot Risks
Women Have Developed Serious Side Effects Like Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) After Using This Birth Control Patch (Posted by Tom Lamb at DrugInjuryWatch.com) On May 8, 2008 Public Citizen’s Health…
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Extent Of Digitek Recall Remains A Mystery Ten Days Later; Patients Are Left In The Dark
Heart Medication Sold By Mylan Was Made In Actavis Plant That Received FDA Letter About Manufacturing Problems Over A Year Ago (Posted by Tom Lamb at DrugInjuryWatch.com) News about the April 2008 Digitek recall…