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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 In the April 19, 2007 New England Journal of Medicine (NEJM) appears "The FDA and the Case of Ketek", by David B. [read post]
22 Sep 2010, 1:01 pm by Tom Lamb
Will This September 2010 EMA Committee Meeting Result In A Consensus, Unlike July 2010 FDA Avandia Panel Voting  (Posted by Tom Lamb at _______________________________________________________________________ UPDATE:  FDA Keeps Diabetes Pill on Market; Europe Suspends Sales  (9/23/10, Wall Street Journal) ______________________________________________________________________________ The Committee for Medicinal Products for Human Use (CHMP), which has… [read post]
20 Aug 2012, 11:15 am by Tom Lamb
This Pradaxa MDL Case Will Include Gastrointestinal Bleeding And Other Hemorrhages As Well As Heart Attacks Or Myocardial Infarctions (Posted by Tom Lamb at Pradaxa is a blood-thinning drug used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.  [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]
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]
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 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]
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 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]
7 Oct 2010, 12:19 pm by Tom Lamb
This October 2010 New Jersey Trial Result Is In Stark Contrast To $3.2 Million Verdict In 2009 Montana Zometa Case (Posted by Tom Lamb at In early October 2010 the New Jersey state court jury which heard the evidence in the case of Bessemer v. [read post]
9 Mar 2012, 3:06 pm by Tom Lamb
Jury Is Told Numerous Times By Her Attorney That Fosamax Did Nothing For Sessner, It Only Did Something To Her (Posted by Tom Lamb at During his March 5, 2012 opening statement the plaintiff's attorney, Tim O'Brien, told members of the jury numerous times that Fosamax did nothing for Jo Ann Sessner, it only did something to her. [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]
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]
25 Aug 2011, 2:02 pm by Tom Lamb
Federal Court Judge Keenan Wants Two More Fosamax - ONJ Bellwether Cases To Go To Jury Verdict After This Trial(Posted by Tom Lamb at UPDATE:  "Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX(R) (alendronate sodium)"  (10/3/11, Merck Press Release)_____________________________________________________________________ UPDATE:  On August 30, 2011 U.S. [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 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]
30 Apr 2012, 1:49 pm by Tom Lamb
While Mediations And Negotiations Continue, The First Scheduled YAZ / Yasmin Trials In Federal And State Courts Are Postponed Indefinitely (Posted by Tom Lamb at 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]
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]
13 Jul 2012, 2:17 pm by Tom Lamb
Greater Risk For Uveitis, Scleritis, And Other Ocular Side Effects According To Two Recent Medical Journal Articles (Posted by Tom Lamb at 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]
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 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]
9 May 2011, 2:13 pm by Tom Lamb
One Sees Mixed Findings About These Fosamax Side Effects From Various Research Reports And Case Studies (Posted by Tom Lamb at Last month we wrote about the status of the thousands of Fosamax lawsuits that have been filed against Merck alleging that the use of this bisphosphonate drug by osteoporosis patients resulted in either atypical low-stress femur fractures or osteonecrosis of the jaw, commonly called ONJ. [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]
5 Nov 2010, 1:14 pm by Tom Lamb
Cases Of Interstitial Lung Disease (ILD) And Rhabdomyolysis / Myopathy Associated With Cholesterol Drugs Known As Statins, Including Zocor  (Posted by Tom Lamb at The October 2010 issue of the Canadian Adverse Reaction Newsletter (CARN) included an article "Statins and interstitial lung disease" which began with these two "Key points": During the last 15 years, 29 cases of interstitial lung disease (ILD) suspected of being associated with statins have been… [read post]