Category: FDA Drug Safety Oversight
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January 2009: ETHEX Corp. Issues Voluntary Recall Of All Pills Due To Suspected Manufacturing Problems
ETHEX Recall Goes To Retail Pharmacy Level For Hydromorphone HCl Tablets And Metoprolol Succinate ER Tablets, Only; All Other ETHEX Generics Recalled To Wholesale Level (Posted by Tom Lamb at DrugInjuryWatch.com) In late December…
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FDA Reports About Eli Lilly’s Drug Strattera Being Associated With Serious Liver Injury Cases
While Strattera Label Has Warning About Liver Injury, Does Current Version Serve To Protect The Millions Of Children Who Take This ADHD Drug? (Posted by Tom Lamb at DrugInjuryWatch.com) In the most recent FDA Drug Safety Newsletter (Volume…
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Actavis And FDA Criticized Over Their Digitek Recall Conduct In New 2009 Report
ISMP QuarterWatch: Cannot "rule out, or state definitively, whether defective digoxin tablets led to hundreds of patient deaths" (Posted by Tom Lamb at DrugInjuryWatch.com) On January 15, 2009 The Institute for Safe Medication Practices…
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Digitek Update December 2008: Actavis Contends No Defective Digitek Pills Were Ever Used By Patients
At About Same Time, Drug Company Accepts FDA Consent Decree In Connection With Justice Department's Injunction Complaint (Posted by Tom Lamb at DrugInjuryWatch.com) In late December 2008 investigative reporter Jeanne Lenzer's hard-hitting article about…
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The Leading Cause Of Drug-Induced Liver Damage Is Use Of Antibiotics Such As Ketek
Two December 2008 Medical Journal Articles Examine Prescription Drug Hepatotoxicity And Reports Of Liver Damage Associated With Ketek (Posted by Tom Lamb at DrugInjuryWatch.com) Antibiotics cause drug-induced liver injury (DILI) more often than other…
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FDA To Study Whether TV DTC Drug Ads Should Include Phone Number For Adverse Event Reporting
Currently Print Drug Ads Are Required To Show Information So That Patients Can Report Serious Side Effects To FDA MedWatch Program (Posted by Tom Lamb at DrugInjuryWatch.com) A November 25, 2008 Associated Press (AP) article, "FDA…
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Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly
Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled (Posted by Tom Lamb at DrugInjuryWatch.com) In an August 26, 2008 Drug…
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FDA And DOJ File Court Papers In November 2008 To Shut Down Actavis Totowa LLC
Federal Government Seeks A Permanent Injunction Against This Drug Company That Produced Defective Digitek Pills (Posted by Tom Lamb at DrugInjuryWatch.com) A November 13, 2008 Bloomberg article, "Actavis Sued by U.S. Regulators to Shut…
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When Will We Learn The Real Extent Of Generic Drug Recalls By Actavis And ETHEX
Numerous Instances Where Out-Of-Spec Oversized Pills With Double The API Dose Are Produced: How And When Did This Happen? (Posted by Tom Lamb at DrugInjuryWatch.com) In late April 2008, when the Digitek recall was announced…
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When Will FDA Report Its Findings About Any Link Between Fosamax And Atrial Fibrillation
In October 2007 The Agency Estimated It Would Need Up To 12 Months To Complete Investigation Regarding This Possible Bisphosphonate Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) The possible link between bisphosphonates such as Fosamax…