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22 Dec 2011, 2:52 pm by Tom Lamb
December 2011: Some Recent Medical Studies About These Bisphosphonate-Related Subtorchanteric Or Atypical Femoral Fractures (Posted by Tom Lamb at Here are some recent reports about medical studies concerning the association, or link, between bisphosphonate drugs such as Fosamax and Boniva that are used to treat osteoporosis and the risk of a rare but serious type of thigh bone fracture known as an "atypical femur fracture. [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by Tom Lamb at On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness"  which provides (and confirms) the real reason that Bristol-Myers Squibb Co. [read post]
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 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]
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… [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]
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]
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]
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]
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… [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]
11 Feb 2008, 9:20 am
February 2008 Australian Report Links Liver Failure And Hepatitis To Popular Novartis Drug (Posted by Tom Lamb at 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 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]
5 Jan 2012, 1:16 pm by Tom Lamb
Ten Strategies Intended For Pharmacists Can Help Patients Stay Safe, Also (Posted by Tom Lamb at 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 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]
21 Aug 2007, 8:26 am
This Second Edition Has Detailed, Useful Information For Doctors And Pharmacists (Posted by Tom Lamb at The August 9, 2007 edition of The New England Journal of Medicine (NEJM) has an insightful book review by John P. [read post]
16 Feb 2007, 7:40 am
Plaintiff Alleged Wyeth Used False And Misleading Advertising For Prempro And Premarin, Thereby Hiding Risks (Posted by Tom Lamb at On February 15, 2007 a federal court jury in Arkansas found the drug company Wyeth not liable for the breast cancer which 72-year old Helene Rush alleged was caused by her use of Prempro and Premarin. [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]
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]
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]