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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]
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]
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]
4 Jul 2009, 8:14 am
New Medical Journal Article Follows June 2009 FDA-Required Warning For Singulair About Neuropsychiatric Events (Posted by Tom Lamb at DrugInjuryWatch.com) On June 12, 2009 the FDA announced a new warning about an increased risk of neuropsychiatric events for the asthma medicine Singulair (montelukast)-- as well as some other less popular leukotriene inhibitors, Accolate (zafirlukast) as well as Zyflo and Zyflo CR (zileuton). [read post]
24 Jan 2011, 12:04 pm
Merck Case Involves Woman Who Alleges She Developed Osteonecrosis Of The Jaw (ONJ) (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: "Merck Wins First Fosamax ‘Jaw Death’ State-Court Trial" (2/14/2011, Bloomberg Businessweek) _____________________________________________________________________ On January 18, 2011 the first Fosamax trial involving bisphosphonate-related… [read post]
13 Jul 2012, 2:17 pm
Greater Risk For Uveitis, Scleritis, And Other Ocular Side Effects According To Two Recent Medical Journal Articles (Posted by Tom Lamb at DrugInjuryWatch.com) Fosamax, Boniva, and other osteoporosis medications in the bisphosphonates drug class have been linked to osteonecrosis of the jaw (ONJ) and atypical femur fractures, with both of these side effects getting considerable coverage in the popular press for some years now. [read post]
30 Apr 2012, 1:49 pm
While Mediations And Negotiations Continue, The First Scheduled YAZ / Yasmin Trials In Federal And State Courts Are Postponed Indefinitely (Posted by Tom Lamb at DrugInjuryWatch.com) In late April 2012 Bayer announced that it has settled lawsuits involving YAZ and Yasmin side effects related to blood clots, namely deep vein thrombosis (DVT) and pulmonary embolism (PE) cases. [read post]
8 Mar 2012, 2:16 pm
Federal Court NuvaRing MDL Bellwether Trial Dates Pushed Back Several Times Previously; Perhaps It Will Be Late 2012 (Posted by Tom Lamb at DrugInjuryWatch.com) The first NuvaRing lawsuit has been scheduled to start trial in February 2013 pursuant to In Re: NuvaRing Litigation Case Management Order (CMO) #19. [read post]
22 Sep 2010, 1:01 pm
Will This September 2010 EMA Committee Meeting Result In A Consensus, Unlike July 2010 FDA Avandia Panel Voting (Posted by Tom Lamb at DrugInjuryWatch.com) _______________________________________________________________________ UPDATE: FDA Keeps Diabetes Pill on Market; Europe Suspends Sales (9/23/10, Wall Street Journal) ______________________________________________________________________________ The Committee for Medicinal Products for Human Use… [read post]
10 Sep 2007, 10:14 am
2007 Medical Journal Article Reports That Ketek May Cause A Greater Than 80% Increased Risk Of Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com) In early September 2007 Health Canada issued a MedEffect alert about Ketek which was based upon their review of the available safety information, including reported cases of severe liver injury. [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]
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]
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]
9 Jan 2009, 11:27 am
Possible Link Between Fosamax And Esophagus Cancer Surfaces; Merck Disputes This New Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) In January 2009 the Journal of the American Dental Association published an article, "Oral bisphosphonate use and the prevalence of osteonecrosis of the jaw", by Parish P. [read post]
4 Apr 2012, 2:10 pm
Neither Recent Nor Past Use Of These Antibiotics In Fluoroquinolones Class Was Related To Retinal Detachment (Posted by Tom Lamb at DrugInjuryWatch.com) Patients taking oral antibiotics known as fluoroquinolones such as Cipro (ciprofloxacin) and Levaquin (levofloxacin) are at an increased risk for developing a detached retina, an eye injury which can lead to permanent blindness if not medically treated in a timely manner. [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]
9 Apr 2009, 12:34 pm
Due To Link With Fatal Brain Infection, Progressive Multifocal Leukoencephalopathy (PML) (Posted by Tom Lamb at DrugInjuryWatch.com) On April 8, 2009 Genentech Inc. -- which was just acquired by Roche Holding AG in March 2009 -- issued a press release announcing "a phased voluntary withdrawal of psoriasis drug Raptiva ® (efalizumab) from the U.S. market" due to its link to a brain infection, progressive multifocal leukoencephalopathy (PML). [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]
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]
