Drug Injury Watch Site provides developing information about prescription drug side effects as well as up-to-date news from the legal, medical, FDA, and pharmaceutical sectors. Statistics Unique Visitors: Total Unique Visitors: Outgoing: Total Outgoing: 0 0 63 3015

Articles from Drug Injury Watch

Women Using Cordarone Five Times More Likely To Need Pacemaker Than Women Who Did Not 2007-08-15 16:41:20 Researchers Find There Is No Such Risk, However, For Men Using This Atrial Fibrillation Heart Drug (Posted by Tom Lamb at DrugInjuryWatch.com) An August 14, 2007 article published by Reuters, "Heart drug may lead to pacemaker use in women", reports a rather peculiar finding concerning the Wyeth (WYE) heart drug Cordarone (amiodarone), used to treat atrial fibrillation, insofar that a serious side effect of this drug appears to affect only women and not men. From the August 14 Reuters article:Dr. Peter Zimetbaum and associates note in the Archives of Internal Medicine [August 13/27, 2007] that amiodarone is more effective than other drugs for maintaining a normal heartbeat in patients with atrial fibrillation, but this comes at the cost of more side effects.... Amiodarone use was identified as a risk factor for requiring a pacemaker. However, further analysis showed that this only applied to women not to men. Women who used amiodarone were nearly five times more likely to ...

Australian Regulators Request That Novartis Withdraw Their Painkiller Drug Prexige 2007-08-13 12:11:25 Prexige Associated With Reports Of Liver Damage, Liver Transplants, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) An August 11, 2007 Bloomberg article, "Novartis' Prexige Painkiller Drug Pulled by Australia", let us know about the latest prescription drug recall. According to this Bloomberg article, eight serious adverse reaction reports about the use of the painkiller Prexige being associated with liver damage have been made to Australia's drugs regulator, the Therapeutic Goods Administration, "including two deaths and two liver transplants".  These adverse reaction reports apparently formed the basis for this Prexige recall in Australia.  In more detail, from this August 11 article:"It seems that the longer people are on the medicine, the greater the chance of liver injury," the [Therapeutic Goods Administration (TGA)] said. Prexige, which is used to treat osteoarthritis as well, is also known as lumiracoxib. "The TGA is, th ...

FDA / Health Canada: Long Term Use Of Nexium And Prilosec May Cause Heart Attacks Or Cardiac Death 2007-08-09 11:31:34 AstraZeneca Study Information Provided To Regulatory Agencies In May 2007 Currently The Subject of Their Ongoing Safety Reviews (Posted by Tom Lamb at DrugInjuryWatch.com) On August 9, 2007 the FDA and Health Canada issued email alerts about possible serious cardiac events in patients using the prescription heartburn drugs Nexium (esomeprazole) and Prilosec (omeprazole), made by AstraZeneca (AZN).  These two drugs are prescribed for the treatment of gastroesophageal reflux disease (GERD), esophageal erosions, and for maintenance of healing erosions of the esophagus. In more detail, the August 9 FDA alert about Nexium and Prilosec directed one to an online document entitled "Early Communication About an Ongoing Safety Review", which includes this introduction to a possible new drug safety issue:FDA has received and is reviewing new safety data about Prilosec (omeprazole) and Nexium (esomeprazole).  On May 29, 2007, AstraZeneca, the manufacturer of Prilosec (omepra ... Health

Avandia Meta-Analysis By Nissen And Wolski Is Analyzed Further, And A Different Result Is Found 2007-08-07 16:36:50 Risk For Heart Attack And Death From Cardiovascular Disease For Diabetic Patients Using Avandia: "Uncertain" (Posted by Tom Lamb at DrugInjuryWatch.com) 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 meta-analysis.  This latest analysis of Avandia (rosiglitazone) study data, done by George A. Diamond, M.D., Leon Bax, M.Sc., and Sanjay Kaul, M.D., will be published in the October 16, 2007 (Volume 147 Issue 8) edition of the Annals of Internal Medicine. The bottom-line conclusion of this latest Avandia article: We conclude that the risk for myocardial infarction and death from cardiovascular disease for diabetic patients taking rosiglitazone is uncertain: Neither increased nor decreased risk is established. Before we delve ...

Drug Safety Update: A Promising New Monthly Electronic Bulletin From The UK's Drug Agency 2007-08-03 16:00:00 First Issue Includes Updated Advice Regarding Dostinex; Now A Second-Line Treatment Due To Increased Risk Of Serious Heart Valve Damage (Posted by Tom Lamb at DrugInjuryWatch.com) In the United Kingdom (UK) the Medicines and Healthcare products Regulatory Agency (MHRA), and its independent advisor the Commission on Human Medicines (CHM), have replaced Current Problems in Pharmacovigilance, which was previously sent in hard copy to certain healthcare professionals, with a new monthly electronic bulletin called Drug Safety Update.  According to an introduction in its first issue, this bulletin is intended to provide useful information for a wide range of healthcare professionals, such as doctors, pharmacists, nurses, and dentists. The first issue of Drug Safety Update, August 2007, included a short but informative piece with current advice about prescribing Dostinex (cabergoline).  As background, Dostinex and Permax (pergolide) are ergotamine dopamine agonists that have ...

Drug Safety Update: A Promising New Monthly Electronic Bulletin From The UK's Drug Agency 2007-08-03 16:00:00 First Issue Includes Updated Advice Regarding Dostinex; Now A Second-Line Treatment Due To Increased Risk Of Serious Heart Valve Damage In the United Kingdom (UK) the Medicines and Healthcare products Regulatory Agency (MHRA), and its independent advisor the Commission on Human Medicines (CHM), have replaced Current Problems in Pharmacovigilance, which was previously sent in hard copy to certain healthcare professionals, with a new monthly electronic bulletin called Drug Safety Update.  According to an introduction in its first issue, this bulletin is intended to provide useful information for a wide range of healthcare professionals, such as doctors, pharmacists, nurses, and dentists. The first issue of Drug Safety Update, August 2007, included a short but informative piece with current advice about prescribing Dostinex (cabergoline).  As background, Dostinex and Permax (pergolide) are ergotamine dopamine agonists that have been associated with cardiovalvulopathy and ...

Millions In U.S. Fail To Take Their Medicine Correctly, And The Consequences Can Be Deadly 2007-08-01 07:20:36 Medication Non-Adherence In America Is A National Crisis Costing Billions Of Dollars According To An August 2007 Report (Posted by Tom Lamb at DrugInjuryWatch.com) Two July 30, 2007 articles by Lauran Neergaard, a reporter who covers health and medical issues for The Associated Press (AP), bring us some important information about prescription medication adherence, or the lack thereof, in the U.S. The first AP article by Ms. Neergaard, titled "Report: Skipping Doses Could Be Deadly" by The Washington Post, presents these findings from a report to be issued in the first part of August 2007 by the nonprofit National Council on Patient Information and Education: Particularly at risk are people whose diseases are initially symptom-free. Although high blood pressure more than triples the risk of heart disease, for example, just 51 percent of patients stick with their prescribed antidote. Also at high risk are the elderly, but adherence is a problem for all ages. As few as 30 percent o ...

Millions In U.S. Fail To Take Their Medicine Correctly, And The Consequences Can Be Deadly 2007-07-31 11:38:52 Medication Non-Adherence In America Is A National Crisis Costing Billions Of Dollars According To An August 2007 Report (Posted by Tom Lamb at DrugInjuryWatch.com) Two July 30, 2007 articles by Lauran Neergaard, a reporter who covers health and medical issues for The Associated Press (AP), bring us some important information about prescription medication adherence, or the lack thereof, in the U.S. The first AP article by Ms. Neergaard, titled "Report: Skipping Doses Could Be Deadly" by The Washington Post, presents these findings from a report to be issued in the first part of August 2007 by the nonprofit National Council on Patient Information and Education: Particularly at risk are people whose diseases are initially symptom-free. Although high blood pressure more than triples the risk of heart disease, for example, just 51 percent of patients stick with their prescribed antidote. Also at high risk are the elderly, but adherence is a problem for all ages. As few as 30 ...

Off-Topic Message: BlawgWorld eBook Includes Drug Injury Watch For Second Year In A Row 2007-07-30 02:11:00 Read Selected Essays From 77 Diverse Legal Blogs (aka Blawgs) In This Free eBook From TechnoLawyer (Posted by Tom Lamb at DrugInjuryWatch.com) On July 30, 2007 TechnoLawyer issued a press release announcing the launch of BlawgWorld 2007, a free eBook that features a diverse and impressive collection of essays from the so-called legal blogosphere.  We are proud that Drug Injury Watch has been selected to be part of the BlawgWorld publication for a second straight year. From TechoLawyer's July 30 press release: BlawgWorld 2007 enables lawyers to find legal blogs of interest fast. More than 120,000 blogs launch every day, many of them in the legal sector. Lawyers clearly do not have the time to read every legal blog (blawg). But many blawgs contain excellent content pertaining to their practice of law. The first edition of BlawgWorld, released in November 2005, was downloaded more than 45,000 times.... Fifty percent larger than its predecessor, BlawgWorld 2007 contains though ...

Vioxx Product Liablity Litigation Update Report From Merck & Co. As Of June 30, 2007 2007-07-25 17:57:00 Company's Latest Estimate On Number Of Personal Injury Lawsuits And Their New List Of Scheduled Trial Dates (Posted by Tom Lamb at DrugInjuryWatch.com) On July 23, 2007 Merck & Co. announced the following information about the Vioxx product liability litigation, as taken from the drug company's press release entitled "Merck Reports Double-Digit Earnings-Per-Share Growth for Second Quarter 2007":As of June 30, the Company had been served or was aware that it had been named as a defendant in approximately 26,950 lawsuits, which include approximately 45,225 plaintiff groups alleging personal injuries resulting from the use of VIOXX.... Of these lawsuits, approximately 8,575 lawsuits representing approximately 23,450 plaintiff groups are or are slated to be in the federal MDL [i.e., multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana] and approximately 16,400 lawsuits representing approximately 16,400 plaintiff groups are included in ... Amp

Vioxx Product Liability Litigation Update Report From Merck & Co. As Of June 30, 2007 2007-07-25 17:57:00 Company's Latest Estimate On Number Of Personal Injury Lawsuits And Their New List Of Scheduled Trial Dates (Posted by Tom Lamb at DrugInjuryWatch.com) On July 23, 2007 Merck & Co. announced the following information about the Vioxx product liability litigation, as taken from the drug company's press release entitled "Merck Reports Double-Digit Earnings-Per-Share Growth for Second Quarter 2007":As of June 30, the Company had been served or was aware that it had been named as a defendant in approximately 26,950 lawsuits, which include approximately 45,225 plaintiff groups alleging personal injuries resulting from the use of VIOXX.... Of these lawsuits, approximately 8,575 lawsuits representing approximately 23,450 plaintiff groups are or are slated to be in the federal MDL [i.e., multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana] and approximately 16,400 lawsuits representing approximately 16,400 plaintiff groups are included in ... Amp

FDA Advisory Committees To Consider Risks And Benefits, If Any, Of Avandia At July 30 Meeting 2007-07-20 17:00:00 July 2007 Cochrane Review Of Trials Contends That Avandia Is No Better Than Other Diabetes Drugs While Being Associated With Serious Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On July 30, 2007 the FDA will convene a Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for the purpose of considering the risk-benefit analysis of GlaxoSmithKline's controversial diabetes drug Avandia (rosiglitazone).  Among the doctors who will be participating are: Curt Furberg, M.D. Steven Nissen, M.D. Thomas Pickering, M.D. David Schade, M.D. Morris Schambelan, M.D. John Teerlink, M.D. Less than two weeks before this FDA meeting about Avandia, a new analysis published by The Cochrane Library asserted that Avandia "does not have a positive impact on patients' quality of life and is not clinically superior to other antidiabetic drugs", according to a July 19, 2007 piece publishe ...

FDA Advisory Committees To Consider Risks And Benefits, If Any, Of Avandia At July 30 Meeting 2007-07-20 17:00:00 July 2007 Cochrane Review Of Trials Contends That Avandia Is No Better Than Other Diabetes Drugs While Being Associated With Serious Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On July 30, 2007 the FDA will convene a Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for the purpose of considering the risk-benefit analysis of GlaxoSmithKline's controversial diabetes drug Avandia (rosiglitazone).  Among the doctors who will be participating are: Curt Furberg, M.D. Steven Nissen, M.D. Thomas Pickering, M.D. David Schade, M.D. Morris Schambelan, M.D. John Teerlink, M.D. Less than two weeks before this FDA meeting about Avandia, a new analysis published by The Cochrane Library asserted that Avandia "does not have a positive impact on patients' quality of life and is not clinically superior to other antidiabetic drugs", according to a July 19, 2007 piece publishe ...

Improvements Needed For Reporting And Evaluating Adverse Drug Reactions In Order To Find Safety Signals 2007-07-17 12:37:20 How Widespread Media Coverage, Increased Data Mining Opportunities, And Online Postings By Doctors Can Give Rise To So-Called False Positives (Posted by Tom Lamb at DrugInjuryWatch.com) The most recent headlines about Avandia are indicative of why improvements are needed as regards how the current system of reporting adverse drug reactions makes it difficult for the FDA to discern true "signals" of serious side effects from the so-called false positives. A July 12, 2007 Associated Press (AP) article, "Avandia: Diabetes Drug Side Effect Reports Triple", provided us with some insight about how the media can affect the number of adverse drug reaction reports that are made to the FDA and why this phenomenon presents a problem:In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.... In the 35 days after May 21,[2007], when the New England Journal of Med ...

Improvements Needed For Reporting And Evaluating Adverse Drug Reactions In Order To Find Safety Signals 2007-07-17 12:37:20 How Widespread Media Coverage, Increased Data Mining Opportunities, And Online Postings By Doctors Can Give Rise To So-Called False Positives (Posted by Tom Lamb at DrugInjuryWatch.com) The most recent headlines about Avandia are indicative of why improvements are needed as regards how the current system of reporting adverse drug reactions makes it difficult for the FDA to discern true "signals" of serious side effects from the so-called false positives. A July 12, 2007 Associated Press (AP) article, "Avandia: Diabetes Drug Side Effect Reports Triple", provided us with some insight about how the media can affect the number of adverse drug reaction reports that are made to the FDA and why this phenomenon presents a problem:In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.... In the 35 days after May 21,[2007], when the New England Journal of Med ...