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7 Aug 2007, 2:36 pm
Risk For Heart Attack And Death From Cardiovascular Disease For Diabetic Patients Using Avandia: "Uncertain" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 6, 2007 the medical journal Annals of Internal Medicine published online an early-release version of a new Avandia article, "Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death", that analyzes the recently reported Nissen and Wolski… [read post]
10 Sep 2008, 9:32 pm
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On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness" which provides (and confirms) the real reason that Bristol-Myers Squibb Co. [read post]
1 Jul 2009, 1:06 pm
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 Chantix (varenicline) as well as Wellbutrin (bupropion) and Zyban (bupropion) which announced that these smoking cessation drugs will be getting a so-called "black-box" warning: ...highlighting the risk of serious neuropsychiatric… [read post]
1 Oct 2009, 12:47 pm
MDL No. 2100 -- IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation -- Assigned To Southern District of Illinois (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Our Focus Page on YAZ / Yasmin / Ocella has a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and… [read post]
25 Sep 2007, 3:00 pm
FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade (Posted by Tom Lamb at DrugInjuryWatch.com) In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox). [read post]
12 Aug 2008, 8:18 pm
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 Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices", we said that soon after the July 4th Congressional recess there would be a bill introduced by Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) [read post]
22 Apr 2007, 12:35 pm
FDA Staffers' Letter To Editor Defends Steps Taken Over Time As Regards This Controversial Sanofi-Aventis Antibiotic (Posted by Tom Lamb at DrugInjuryWatch.com) In the April 19, 2007 New England Journal of Medicine (NEJM) appears "The FDA and the Case of Ketek", by David B. [read post]
16 Mar 2009, 11:20 am
Nonetheless, Pending Byetta Label Change Will Probably Add Stronger Warnings About Severe Pancreatitis Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) As some may recall, in August 2008 the FDA issued a MedWatch alert about six cases of hemorrhagic pancreatitis and necrotizing pancreatitis associated with the diabetes medicine Byetta. [read post]
4 Aug 2009, 10:02 am
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 companies developing new prescription drugs which explains how certain laboratory measurements obtained in clinical trials can be used to assess the new drug's potential to cause severe… [read post]
6 Aug 2008, 1:40 pm
August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. [read post]
16 May 2011, 1:03 pm
A Pulmonary Embolism Case Is Selected By Judge Herndon; More Than 6600 Lawsuits Filed Against Bayer As Of May 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2011 federal court Judge David R. [read post]
11 Feb 2008, 9:20 am
February 2008 Australian Report Links Liver Failure And Hepatitis To Popular Novartis Drug (Posted by Tom Lamb at DrugInjuryWatch.com) A February 4, 2008 article, "Anti-fungal tablet linked to liver deaths", published by Australia's Herald Sun newspaper, brought to our attention the fact that Australian drug regulators have issued a warning about serious liver reactions after taking a popular prescription drug used to treat fungal infections, Lamisil… [read post]
5 Jan 2012, 1:16 pm
Ten Strategies Intended For Pharmacists Can Help Patients Stay Safe, Also (Posted by Tom Lamb at DrugInjuryWatch.com) It is relatively well-accepted in the healthcare community that medication errors involving prescription drugs happen more often than they should but the incident rate could be reduced if both pharmacists and patients took certain precautions. [read post]
16 May 2007, 10:34 am
Plaintiff Simon Developed Breast Cancer After Using HRT Drugs Prempro, Premarin, And Provera (Posted by Tom Lamb at DrugInjuryWatch.com) On May 15, 2007 a Pennsylvania state court jury handed down a mixed verdict in the latest hormone replacement therapy (HRT) products liability case to go to trial, Simon v. [read post]
15 May 2009, 10:10 am
Some Ways That Free Drug Samples Can Harm Patients (Posted by Tom Lamb at DrugInjuryWatch.com) PLoS Medicine-- which is a peer-reviewed open-access journal published by the Public Library of Science -- published an essay by Susan Chimonas and Jerome P. [read post]
4 May 2012, 2:02 pm
A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease (Posted by Tom Lamb at DrugInjuryWatch.com) As regards the possible association between Victoza and pancreatitis as a side effect of this diabetes drug from Novo Nordisk, there have quite a few assorted developments during the period April 2011 to April 2012. [read post]
22 Sep 2011, 12:00 pm
EMA Cites The Increased Risks Of Liver Injury, Lung Side Effects, And Cardiovascular Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) In late September 2011 the European Medicines Agency (EMA) recommended that the use of Sanofi's antiarrhythmic medication Multaq (dronedarone) be restricted to certain patients with paroxysmal or persistent atrial fibrillation. [read post]
21 May 2007, 10:41 am
(Posted by Tom Lamb at DrugInjuryWatch.com) On May 21, 2007 the Los Angeles Times published an Associated Press (AP) article entitled "Diabetes drug linked to heart attack risk" which broke the story about a new analysis of Avandia data that was published online earlier this same day by the New England Journal of Medicine (NEJM). [read post]
31 Aug 2009, 1:45 pm
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 Communication" notification about an ongoing safety review of the obesity drugs Xenical (orlistat 120 mg) and Alli (orlistat 60 mg). [read post]
14 Nov 2008, 3:23 pm
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. [read post]
