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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]
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]
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]
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]
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]
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]
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]
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]
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]
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 DrugInjuryWatch.com) 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]
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 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]
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]
18 Feb 2010, 12:52 pm
Reports About Sudden Breaking Of Thigh Bone In Patients Using Fosamax For Five Years Or More (Posted by Tom Lamb at DrugInjuryWatch.com) The side effects of Fosamax include osteonecrosis of the jaw (ONJ), esophageal irritation, and musculoskeletal pain. [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]
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 DrugInjuryWatch.com) 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]
21 Aug 2007, 8:26 am
This Second Edition Has Detailed, Useful Information For Doctors And Pharmacists (Posted by Tom Lamb at DrugInjuryWatch.com) The August 9, 2007 edition of The New England Journal of Medicine (NEJM) has an insightful book review by John P. [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]
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]
28 Oct 2011, 6:16 pm
(Posted by Tom Lamb at DrugInjuryWatch.com) On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the NuvaRing (etonogestrel / estradiol vaginal ring) -- referred to as "ETON" in this 2011 FDA study report. [read post]
