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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 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]
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 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]
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 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 In the April 19, 2007 New England Journal of Medicine (NEJM) appears "The FDA and the Case of Ketek", by David B. [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 On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. [read post]
16 May 2011, 1:03 pm by Tom Lamb
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 In May 2011 federal court Judge David R. [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 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 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]
20 Sep 2007, 3:04 pm
FDA Links Cephalon's Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). [read post]
8 Mar 2012, 2:16 pm by Tom Lamb
Federal Court NuvaRing MDL Bellwether Trial Dates Pushed Back Several Times Previously; Perhaps It Will Be Late 2012 (Posted by Tom Lamb at 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]
24 Jan 2011, 12:04 pm by Tom Lamb
Merck Case Involves Woman Who Alleges She Developed Osteonecrosis Of The Jaw (ONJ)  (Posted by Tom Lamb at _____________________________________________________________________ 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]
4 May 2012, 2:02 pm by Tom Lamb
A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease (Posted by Tom Lamb at 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 by Tom Lamb
EMA Cites The Increased Risks Of Liver Injury, Lung Side Effects, And Cardiovascular Adverse Events (Posted by Tom Lamb at 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 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 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 A November 13, 2008 Bloomberg article, "Actavis Sued by U.S. [read post]
19 Oct 2007, 6:35 am
This Medtronic Defibrillator Lead Line Was Particularly Popular In Younger Patients Due To Its Smaller Size (Posted by Tom Lamb at In an October 19, 2007 article, "Heart Wires May Pose More Risk for the Young", Wall Street Journal (WSJ) reporters Anna Wilde Mathews and Thomas M. [read post]
13 Aug 2009, 2:43 pm
Combination Of Ethinylestradiol And Drospirenone Increases Serum Copper, A Situation That Could Be Associated With Increased Cardiovascular Risk (Posted by Tom Lamb at In the August 1, 2009 edition of the medical journal Contraception there was an article which offers one possible explanation about why Yasmin and YAZ might cause an increased risk of developing serious side effects involving blood clots, such as pulmonary embolism (PE), deep vein thrombosis… [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 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 by Tom Lamb
Neither Recent Nor Past Use Of These Antibiotics In Fluoroquinolones Class Was Related To Retinal Detachment (Posted by Tom Lamb at 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]