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15 Mar 2012, 11:40 am
820 Cases Are Filed In Federal Court NuvaRing MDL And 125 Lawsuits Are Part Of New Jersey State Court Mass Tort (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of NuvaRing lawsuits that had been filed before January 2012 comes from page 119 of the Merck & Co., Inc. [read post]
2 Nov 2011, 1:47 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 Ortho Evra birth control skin patch (norelgestromin/ethinyl estradiol transdermal patch) -- referred to as "NGMN" in this 2011 FDA study report. [read post]
Procrit, Epogen, And Aranesp: New "Black Box" Warnings Only First Part Of FDA's Safety Re-evaluation
12 Mar 2007, 10:10 am
Popular Anemia Drugs Have Increased Risk Of Death, Blood Clots, Strokes, And Heart Attacks, Especially In Context Of Off-label Prescribing And Use (Posted by Tom Lamb at DrugInjuryWatch.com) On March 9, 2007 the FDA announced that Amgen Inc. and Johnson & Johnson (J&J) would add strong new warnings to their anemia drugs Procrit, Epogen, and Aranesp after several recent studies showed a higher risk of death and life-threatening side effects in some patients. [read post]
9 May 2012, 12:51 pm
825 Lawsuits Are Part Of New Jersey State Court Mass Tort Consolidation; Majority Of Other Cases Are Filed In "Second" Fosamax Federal Court MDL (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of Fosamax - femur fracture lawsuits that had been filed before January 2012 comes from pages 117-118 of the Merck & Co., Inc. [read post]
30 Sep 2010, 1:18 pm
Two More Fosamax Lawsuits Involving Jaw Injury Like Osteonecrosis Of The Jaw (ONJ) Will Go To Trial In Spring 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) _______________________________________________________________________________ UPDATE: Merck Not at Fault in Fosamax Trial, Jurors Say (New York Times, 11/19/10) ... [read post]
Will New Black Box Warning About Heart Attacks Lead GlaxoSmithKline To Withdraw Avandia From Market?
9 Nov 2007, 9:03 am
One Wonders Whether GSK Might Do A "Soft" Recall Of Its Embattled Diabetes Drug, As Was Done By BMS With Serzone And Tequin In Recent Years (Posted by Tom Lamb at DrugInjuryWatch.com) Avandia (rosiglitazone) is a prescription drug from GlaxoSmithKline (GSK) approved by the FDA in 1999 to treat Type 2 diabetes. [read post]
24 Feb 2009, 1:18 pm
Physicians Must Consider The Pros And Cons Of Surgical Removal Before Heart Device Shocks Unnecessarily Or Fails To Work When Patient Needed Shock (Posted by Tom Lamb at DrugInjuryWatch.com) On February 23, 2009 the medical journal HeartRhythm made available online an article by Robert G. [read post]
9 Jan 2008, 2:41 pm
Vioxx Lawsuits (Posted by Tom Lamb at DrugInjuryWatch.com) We learned from a January 9, 2009 post, "Webcast of Vioxx Settlement Panel" -- which we found when taking our daily look at the Drug and Device Law blog -- that you can now view online for free C-SPAN's broadcast of "The Vioxx Settlement" panel discussion which took place in Washington, D.C. on the afternoon of January 7, 2008 at the American Enterprise Institute (AEI). [read post]
31 Oct 2011, 1:39 pm
Safety Study Findings About Drospirenone (DRSP) Birth Control Pills Will Be On The Agenda For FDA Advisory Committees At Joint Meeting In December 2011 (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 popular birth control pills YAZ, Yasmin, and Ocella. [read post]
1 Feb 2008, 2:53 pm
Three Medical Journal Articles From Late 2007 Shed More Light On Risk Factors, Prevention, And Treatment Of These Serious Bone Diseases Associated With Fosamax And Similar Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) We start our review of recent medical journal articles about bisphosphonate-induced osteonecrosis and osteomyelitis of the jaw with a November 2007 article, "Bisphosphonates and Bisphosphonate Induced Osteonecrosis", written by Yoh Sawatari and… [read post]
4 Sep 2008, 9:08 pm
2008 Medical Journal Articles Describe Two Cases; Authors Suggest Liver Testing At Start Of Therapy And When Titrating Dosage Is Necessary (Posted by Tom Lamb at DrugInjuryWatch.com) In December 2007 we told you about an article by New York Times (NYT) reporter Alex Berenson, "Data About Zetia Risks Was Not Fully Revealed", which revealed that Merck and Schering-Plough had conducted several studies of Zetia that raised the possibility that Zetia can cause… [read post]
10 Sep 2010, 1:27 pm
NEJM Editorial: There Should Be A Meridia Recall As The Risk Of Heart-Related Side Effects Is Greater Than Any Weight-Loss Benefit (Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: Abbott Pulls Meridia in U.S. [read post]
31 Aug 2012, 2:30 pm
Approved By FDA In 2010, There Has Been No Study Done Yet Regarding Beyaz Safety -- Despite Significant Number Of Beyaz Adverse Event Reports (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: FDA Meeting Materials for Pediatric Focused Safety Review: Beyaz (ethinyl estradiol, drospirenone, levomefolate calcium) Pediatric Advisory Committee Meeting September 11, 2012 (PowerPoint PDF) (9/19/12)… [read post]
28 Mar 2008, 7:42 am
A Couple Of Recent Offerings From Our Readers, For Your Consideration (Posted by Tom Lamb at DrugInjuryWatch.com) As you will see, we have two readers who emailed me recently to thank for today's post. [read post]
6 May 2009, 3:01 pm
May 12 Hearing In Washington Begins The Debate About Whether The Medical Device Industry Should Have Total Immunity From Legal Liability (Posted by Tom Lamb at DrugInjuryWatch.com) On May 12, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009. [read post]
2 Nov 2010, 11:00 am
Merck Issues Its "No Liability" Press Release On First Day Of Trial; 1092 Fosamax Lawsuits Filed As Of June 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Merck Not at Fault in Fosamax Trial, Jurors Say (New York Times, 11/19/10) ... [read post]
23 Feb 2010, 1:34 pm
Heart Risk Is Current Focus Due To GlaxoSmithKline Past Conduct; But Public Citizen Has Pointed The Liver Failure Case Reports Linked To Avandia, Also(Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, in October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U.S. because its risks, which include heart attack and heart failure in addition to liver toxicity, far outweigh its benefits and… [read post]
2 May 2011, 1:12 pm
April 2011 Edition Of BMJ Breaks News And Provides Insight From One Who Saw An Increased Risk Of Pancreatitis (Posted by Tom Lamb at DrugInjuryWatch.com) According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin)… [read post]
24 May 2007, 3:47 pm
In Comparison, Europe's Regulators Had Glaxo Change Avandia Label In 2006 To Include Warning About Risk Of Cardiac Ischemic Events Such As Heart Attacks (Posted by Tom Lamb at DrugInjuryWatch.com) In a May 24, 2007 New York Times (NYT) article about Avandia, Stephanie Sauls and Gardiner Harris reported the FDA was put on notice as far back as 2000 that there was concern in parts of the medical community about the cardiovascular safety of Avandia, a diabetes drug from… [read post]
3 Oct 2012, 11:00 am
Newly Available Expert Analysis Of Confidential Drug Company Data Reveals That NuvaRing Estrogen Levels In Studies Were A Cause For Concern, And The Method Of Reporting Was Misleading (Posted by Tom Lamb at DrugInjuryWatch.com) In the pending NuvaRing litigation a federal judge recently unsealed some significant documents previously protected under claims of confidentiality. [read post]
