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Where Are The Medical Journal Articles About Problems With Studies On Zetia And Vytorin? 2008-01-11 09:32:43 Dr. Blumsohn Shines His Bright Light On This Troubling Situation And Provides A Lengthy List Of Recent Blog Posts About Zetia And Vytorin (Posted by Tom Lamb at DrugInjuryWatch.com) Over at the Scientific Misconduct Blog, Dr. Aubrey Blumsohn has posted an article, "Ezetimibe - where are our medical journals?", which makes one wonder if Zetia and Vytorin are getting off easy in the medical journal world. From Dr. Blumsohn's Jaunuary 11, 2008 post on Zetia (ezetimibe):The huge ethical and scientific problems with the drug Ezetimibe have been discussed widely in the lay press (especially in the New York Times). The problems have been discussed by patients, on the internet and in the blogsphere. However as of today, a search of our key medical journals reveals no hint of any ethical discussion. No discussion of the principles of good science. Not even a worthy news report. Nothing at all.The British medical Journal : No discussion The Lancet: On 24 November 2007 in the midst ... Articles

Video Of January 2008 Vioxx Settlement Panel Discussion Is Available Online 2008-01-09 16:41:11 Lawyers And Law Professors Discuss The Good, The Bad, And The Ugly Of Merck's Proposed "Global Settlement" Of All U.S. 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). In addition, on the AEI web page for this January 2008 panel discussion of Merck's proposed Vioxx settlement there is a link to the video, at top of right side bar.  (One small advantage to using this means of viewing "The Vioxx Settlement" event is that you don't have to watch some of those people in attendance eat their lunch at the start, as you do on the C-SPAN webcast.) From that the AEI ...

Video Of January 2008 Vioxx Settlement Panel Discussion Is Available Online 2008-01-09 16:41:11 Lawyers And Law Professors Discuss The Good, The Bad, And The Ugly Of Merck's Proposed "Global Settlement" Of All U.S. 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). In addition, on the AEI web page for this January 2008 panel discussion of Merck's proposed Vioxx settlement there is a link to the video, at top of right side bar.  (One small advantage to using this means of viewing "The Vioxx Settlement" event is that you don't have to watch some of those people in attendance eat their lunch at the start, as you do on the C-SPAN webcast.) From that the AEI ...

Reports Of Tendon Ruptures Caused By Antibiotics Levaquin, Cipro, And Avelox 2008-01-04 10:33:31 Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's Levaquin as well as Bayer AG's Cipro and Avelox. This Public Citizen lawsuit was filed in federal court, specifically the U.S. District Court for the District of Columbia. In August 2006 Public Citizen petitioned the FDA to add a "black box" warning to alert doctors and patients about the risk of tendon injury and rupture associated with Levaquin, Cipro, and Avelox, as well as generic antibiotics sold under the name ciprofloxacin -- all being in the fluoroquinolones class of drugs. According to the January 3 Reuters article about t ...

Reports Of Tendon Ruptures Caused By Antibiotics Levaquin, Cipro, And Avelox 2008-01-04 10:33:31 Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's Levaquin as well as Bayer AG's Cipro and Avelox. This Public Citizen lawsuit was filed in federal court, specifically the U.S. District Court for the District of Columbia. In August 2006 Public Citizen petitioned the FDA to add a "black box" warning to alert doctors and patients about the risk of tendon injury and rupture associated with Levaquin, Cipro, and Avelox, as well as generic antibiotics sold under the name ciprofloxacin -- all being in the fluoroquinolones class of drugs. According to the January 3 R ...

Senator Grassley's December 2007 Letter To FDA Questions Agency's Approval Of Ketek 2008-01-02 11:12:00 Sanofi-Aventis Antibiotic Has Been Subject Of Controversy Since Reports of Liver Damage Surfaced In Early 2006 (Posted by Tom Lamb at DrugInjuryWatch.com) The safety concerns about Ketek (telithromycin) began in early 2006 after Health Canada and the European Union's European Medicines Agency (EMEA) issued alerts based on the online "early" release of an article about Ketek that would later be published in the March 21, 2006 edition of the Annals of Internal Medicine.  This article reported three cases in a North Carolina hospital where there was liver failure associated with Ketek use. In May 2006 Senator Charles Grassley (R-Ill.) as well as Congressmen Edward Markey (D-Mass.) and Henry Waxman (D-Calf.) asked the FDA for some explanation about the agency's decision to approve the antibiotic Ketek in 2004.  This scrutiny from Capitol Hill followed in the wake of a May 1, 2006 investigative piece in The Wall Street Journal about how the FDA approved Ketek despi ...

Senator Grassley's December 2007 Letter To FDA Questions Agency's Approval Of Ketek 2008-01-02 11:12:00 Sanofi-Aventis Antibiotic Has Been Subject Of Controversy Since Reports of Liver Damage Surfaced In Early 2006 (Posted by Tom Lamb at DrugInjuryWatch.com) The safety concerns about Ketek (telithromycin) began in early 2006 after Health Canada and the European Union's European Medicines Agency (EMEA) issued alerts based on the online "early" release of an article about Ketek that would later be published in the March 21, 2006 edition of the Annals of Internal Medicine.  This article reported three cases in a North Carolina hospital where there was liver failure associated with Ketek use. In May 2006 Senator Charles Grassley (R-Ill.) as well as Congressmen Edward Markey (D-Mass.) and Henry Waxman (D-Calf.) asked the FDA for some explanation about the agency's decision to approve the antibiotic Ketek in 2004.  This scrutiny from Capitol Hill followed in the wake of a May 1, 2006 investigative piece in The Wall Street Journal about how the FDA approved Ketek despi ...

Case Report Shows How Diagnosis Of Ketek-Induced Liver Injury Is Made By Doctors 2007-12-28 17:14:00 Abnormal Liver Function Tests In Man With No Hepatotoxicity Risk Factors After Taking Ketek For Three Days Indicates Drug Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) As we have reported previously, use of the antibiotic Ketek appears to significantly increase one's risk of developing liver damage. A medical journal Case Report article by Scott Bolesta and Brian P. Roslund, "Elevated hepatic transaminases associated with telithromycin therapy: A case report and literature review", provides insight as to how a case of liver damage can be attributed to the patient's use of Ketek (telithromycin).  This article was published in the American Journal of Health-System Pharmacy (Vol. 65, Issue 1, 2008). The clinical setting is that a 44-year-old man with no risk factors for hepatotoxicity nor any other significant past medical history presented at the emergency room complaining of high fever, chills, headache, neck stiffness, and back pain for the past six days. ...

Case Report Shows How Diagnosis Of Ketek-Induced Liver Injury Is Made By Doctors 2007-12-28 17:14:00 Abnormal Liver Function Tests In Man With No Hepatotoxicity Risk Factors After Taking Ketek For Three Days Indicates Drug Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) As we have reported previously, use of the antibiotic Ketek appears to significantly increase one's risk of developing liver damage. A medical journal Case Report article by Scott Bolesta and Brian P. Roslund, "Elevated hepatic transaminases associated with telithromycin therapy: A case report and literature review", provides insight as to how a case of liver damage can be attributed to the patient's use of Ketek (telithromycin).  This article was published in the American Journal of Health-System Pharmacy (Vol. 65, Issue 1, 2008). The clinical setting is that a 44-year-old man with no risk factors for hepatotoxicity nor any other significant past medical history presented at the emergency room complaining of high fever, chills, headache, neck stiffness, and back pain for the past six days. ...

Cholesterol Drug Zetia May Cause Serious Liver Injury Including Hepatitis And Liver Failure 2007-12-21 13:51:11 Health Canada First Raised This Zetia Safety Issue In February 2005; News Reporter Discovers In December 2007 That Information Known By Merck and Schering-Plough About These Zetia Side Effects May Have Been Withheld (Posted by Tom Lamb at DrugInjuryWatch.com) Back on February 1, 2005 Health Canada posted on its web site a so-called "Dear Doctor" letter about Zetia (ezetimibe) -- called Ezetrol in Canada -- from Merck Frosst / Schering Pharmaceuticals that was intended to draw attention to some serious side effects associated with Zetia.  That 2005 Dear Doctor letter included the following:The Warnings, Precautions, and Adverse Events sections are being updated to reflect the occurrence of the following adverse events in patients taking Ezetrol® (ezetimibe) alone or in combination with a statin: myalgia; rhabdomyolysis; hepatitis; acute pancreatitis; thrombocytopenia; and suspected interaction between Ezetrol® (ezetimibe) and warfarin  In the U.S., ho ...

Medtronic Sprint Fidelis Lead Defect Can Be More Of A Problem For Certain Patients 2007-12-18 16:16:00 People With Hypertrophic Cardiomyopathy And Those With Defibrillator-Pacemaker Dual Unit Implants May Be More In Need Of Lead Wire Replacement After Medtronic Recall (Posted by Tom Lamb at DrugInjuryWatch.com) As presented in a December 13, 2007 New York Times (NYT) article, "Patients Wonder Whether to Replace a Wire That Might Fail", for thousands of people the October 2007 Medtronic recall of its Sprint Fidelis lead wires has created confusion and doubt on various levels about what they can or should do, now:Their defibrillators are meant to deliver electric shocks to restore normal rhythms if their hearts start beating chaotically. Should they have the potentially faulty wire, or lead, removed — or leave it in place and hope it does not fail? And if they do have it extracted, how will they pay for it? Medtronic is limiting its contribution to only a replacement lead and $800 toward each procedure, which can cost $12,500 or more. So far insurers are deciding whether to ...

More Reports of Women Who Have Had Serious Blood Clot Problems When Using NuvaRing 2007-12-13 12:16:22 Serious Adverse Reactions With This Vaginal Ring Birth Control Device Include Deep Vein Thrombosis (DVT) And Pulmonary Emboli (PE) (Posted by Tom Lamb at DrugInjuryWatch.com) An abstract from the annual meeting of the American Society of Hematology (ASH) entitled "Venous Thromboembolic Events in Women Using the NuvaRing®." (Blood -- ASH Annual Meeting Abstracts -- 2007 110: Abstract 3994) concludes with this statement:Longer follow-up of safety studies and post-marketing adverse event reporting are needed to determine VTE [(venous thromboembolic event)] risks and incidence while using the NuvaRing®.In arriving at that conclusion, Merrill K. Shum, MD, Kumar Rajagopalan, MD, and Neil A. Lachant, MD, considered three cases they had observed of women using NuvaRing who had developed complications involving blood clots as well as ten other women with serious side effects while using NuvaRing whom they had identified by searching the medical literature:We report 3 women who dev ...

More Reports of Women Who Have Had Serious Blood Clot Problems When Using NuvaRing 2007-12-13 12:16:22 Serious Adverse Reactions With This Vaginal Ring Birth Control Device Include Deep Vein Thrombosis (DVT) And Pulmonary Emboli (PE) (Posted by Tom Lamb at DrugInjuryWatch.com) An abstract from the annual meeting of the American Society of Hematology (ASH) entitled "Venous Thromboembolic Events in Women Using the NuvaRing??." (Blood -- ASH Annual Meeting Abstracts -- 2007 110: Abstract 3994) concludes with this statement:Longer follow-up of safety studies and post-marketing adverse event reporting are needed to determine VTE [(venous thromboembolic event)] risks and incidence while using the NuvaRing??.In arriving at that conclusion, Merrill K. Shum, MD, Kumar Rajagopalan, MD, and Neil A. Lachant, MD, considered three cases they had observed of women using NuvaRing who had developed complications involving blood clots as well as ten other women with serious side effects while using NuvaRing whom they had identified by searching the medical literature:We report 3 women who dev ...

Federal Court Filing Asserts That Johnson & Johnson Altered And Withheld Data About Health Risks Of Ortho Evra Birth Control Patch 2007-12-12 16:50:00 As Of November 2007 J&J Faces 2400 Lawsuits Involving Strokes, Heart Attacks, And Blood Clots Allegedly Caused By Ortho Evra, With Most Cases Pending Before MDL Judge Katz (Posted by Tom Lamb at DrugInjuryWatch.com) In legal motions filed November 20, 2007 by lawyers representing women claiming to have been injured by their use of the Ortho Evra birth control patch, it is asserted that the drug company Johnson & Johnson (J&J) misled the FDA and doctors in the years leading up to the time that "the Patch" was approved for use by women in the U.S. According to a November 29, 2007 Bloomberg article, "J&J Altered Birth-Control Patch Data to Hide Risks", these contentions of misconduct by J&J were presented to U.S. District Judge David Katz, of the U.S. District Court, North District of Ohio, in Toledo, who is the presiding judge for In re Ortho Evra Products Liability Litigation, Multi-district Litigation (MDL) 1742, where currently approximately ... Amp  Health

Federal Court Filing Asserts That Johnson & Johnson Altered And Withheld Data About Health Risks Of Ortho Evra Birth Control Patch 2007-12-12 16:50:00 As Of November 2007 J&J Faces 2400 Lawsuits Involving Strokes, Heart Attacks, And Blood Clots Allegedly Caused By Ortho Evra, With Most Cases Pending Before MDL Judge Katz (Posted by Tom Lamb at DrugInjuryWatch.com) In legal motions filed November 20, 2007 by lawyers representing women claiming to have been injured by their use of the Ortho Evra birth control patch, it is asserted that the drug company Johnson & Johnson (J&J) misled the FDA and doctors in the years leading up to the time that "the Patch" was approved for use by women in the U.S. According to a November 29, 2007 Bloomberg article, "J&J Altered Birth-Control Patch Data to Hide Risks", these contentions of misconduct by J&J were presented to U.S. District Judge David Katz, of the U.S. District Court, North District of Ohio, in Toledo, who is the presiding judge for In re Ortho Evra Products Liability Litigation, Multi-district Litigation (MDL) 1742, where currently approximately ... Amp  Health