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Articles from Drug Injury Watch

The Use Of Antibiotic Ketek Appears To Significantly Increase Risk Of Liver Damage And Injury 2007-09-10 12:14:00 2007 Medical Journal Article Reports That Ketek May Cause A Greater Than 80% Increased Risk Of Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com) 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. In the end, Health Canada determined that the benefit-risk profile for Ketek no longer supported the use of this antibiotic for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, tonsillitis, or pharyngitis. For more information about the extent of the liver injury risk associated with Ketek (telithromycin) we consider a medical article, "Telithromycin use and spontaneous reports of hepatotoxicity", that was published in the January 1, 2007 edition of the medical journal Drug Safety.  Therein the authors' primary aim was to quantify the effect of Ketek on serious liver injury, or hepatotoxi ...

The Use Of Antibiotic Ketek Appears To Significantly Increase Risk Of Liver Damage And Injury 2007-09-10 12:14:00 2007 Medical Journal Article Reports That Ketek May Cause A Greater Than 80% Increased Risk Of Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com) 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. In the end, Health Canada determined that the benefit-risk profile for Ketek no longer supported the use of this antibiotic for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, tonsillitis, or pharyngitis. For more information about the extent of the liver injury risk associated with Ketek (telithromycin) we consider a medical article, "Telithromycin use and spontaneous reports of hepatotoxicity", that was published in the January 1, 2007 edition of the medical journal Drug Safety.  Therein the authors' primary aim was to quantify the effect of Ketek on serious liver injury, or hepatotoxi ...

Health Canada Issues Ketek MedEffect Alert In Early September 2007 2007-09-06 16:56:00 Antibiotic Ketek Restricted To Certain Types Of Pneumonia; No Longer Used For Sinusitis, Bronchitis, Tonsillitis, Pharyngitis (Posted by Tom Lamb at DrugInjuryWatch.com) On September 5, 2007 Health Canada issued by email a MedEffect alert about Ketek which included this summary:Sanofi-aventis Canada, Inc. is informing Canadians that the antibiotic Ketek (telithromycin), should no longer be used to treat sinusitis, bronchitis, tonsillitis or pharyngitis. Ketek can still be used to treat certain types of pneumonia.More information about these restrictions imposed on Ketek in Canada are set forth in the accompanying "PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on KETEK (telithromycin)" and the the so-called "Dear Doctor" letter sent to health care professionals by Sanofi-aventis Canada Inc. on August 30, 2007. From this Canadian Ketek Dear Doctor letter we get this more in-depth information about this change in indications for Ketek in C ... Health

Health Canada Issues Ketek MedEffect Alert In Early September 2007 2007-09-06 16:56:00 Antibiotic Ketek Restricted To Certain Types Of Pneumonia; No Longer Used For Sinusitis, Bronchitis, Tonsillitis, Pharyngitis (Posted by Tom Lamb at DrugInjuryWatch.com) On September 5, 2007 Health Canada issued by email a MedEffect alert about Ketek which included this summary:Sanofi-aventis Canada, Inc. is informing Canadians that the antibiotic Ketek (telithromycin), should no longer be used to treat sinusitis, bronchitis, tonsillitis or pharyngitis. Ketek can still be used to treat certain types of pneumonia.More information about these restrictions imposed on Ketek in Canada are set forth in the accompanying "PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on KETEK (telithromycin)" and the the so-called "Dear Doctor" letter sent to health care professionals by Sanofi-aventis Canada Inc. on August 30, 2007. From this Canadian Ketek Dear Doctor letter we get this more in-depth information about this change in indications for Ketek in C ... Health

Current Evidence Of Associations Between Hormone-Replacement Therapy Drugs And Several Serious Side Effects 2007-09-04 11:03:25 Drug Safety Update Publishes September 2007 Guide For Doctors To Assess HRT Risks And Benefits (Posted by Tom Lamb at DrugInjuryWatch.com) The second issue of Drug Safety Update, an electronic bulletin (PDF file) published by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), was published on September 3, 2007. It includes some important side effects information for doctors who prescribe hormone-replacement therapy (HRT). As described by Claire Tilstone, the Editor of Drug Safety Update:  We have prepared digested guide of current evidence for the associations between HRT and coronary heart disease; stroke; venous thromboembolism; and cancers of the breast, endometrium, or ovary. We hope that this updated information, includingrevised risk estimates, will help healthcare professionals assess the risks andbenefits associated with HRT for individual women.Of course, this advisory article from Volume 1, Issue 2 of Drug Safety Update will also be of interest to s ...

Current Evidence Of Associations Between Hormone-Replacement Therapy Drugs And Several Serious Side Effects 2007-09-04 11:03:25 Drug Safety Update Publishes September 2007 Guide For Doctors To Assess HRT Risks And Benefits (Posted by Tom Lamb at DrugInjuryWatch.com) The second issue of Drug Safety Update, an electronic bulletin (PDF file) published by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), was published on September 3, 2007. It includes some important side effects information for doctors who prescribe hormone-replacement therapy (HRT). As described by Claire Tilstone, the Editor of Drug Safety Update:  We have prepared digested guide of current evidence for the associations between HRT and coronary heart disease; stroke; venous thromboembolism; and cancers of the breast, endometrium, or ovary. We hope that this updated information, includingrevised risk estimates, will help healthcare professionals assess the risks andbenefits associated with HRT for individual women.Of course, this advisory article from Volume 1, Issue 2 of Drug Safety Update will also be of interest to s ...

NuvaRing Birth Control Device Can Cause Pulmonary Embolism, Deep Vein Thrombosis, Stroke, And Heart Attack: Part Two 2007-08-29 23:01:00 Does Organon's Current NuvaRing Label Have Sufficient Warnings About Risk Of Blood Clots And Related Conditions (Posted by Tom Lamb at DrugInjuryWatch.com) In Part One of this series about NuvaRing we looked at some medical information about the so-called "third generation" progestin desogestrel causing a significant increased risk of venous thromboembolism, or serious blood clots; in turn, these blood clots can develop into a pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke (CVA), and myocardial infarction (MI) or heart attack.  That medical information is relevant to the emerging drug safety concerns about NuvaRing because Organon's contraceptive vaginal ring contains a relatively high dose of a similar progestin, etonogestrel, which is a metabolite of desogestrel. In this part of our series about NuvaRing we review some of the warnings about a woman's risk of developing blood clots found in the current NuvaRing Physician's Insert -- more g ...

NuvaRing Birth Control Device Can Cause Pulmonary Embolism, Deep Vein Thrombosis, Stroke, And Heart Attack: Part Two 2007-08-29 23:01:00 Does Organon's Current NuvaRing Label Have Sufficient Warnings About Risk Of Blood Clots And Related Conditions (Posted by Tom Lamb at DrugInjuryWatch.com) In Part One of this series about NuvaRing we looked at some medical information about the so-called "third generation" progestin desogestrel causing a significant increased risk of venous thromboembolism, or serious blood clots; in turn, these blood clots can develop into a pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke (CVA), and myocardial infarction (MI) or heart attack.  That medical information is relevant to the emerging drug safety concerns about NuvaRing because Organon's contraceptive vaginal ring contains a relatively high dose of a similar progestin, etonogestrel, which is a metabolite of desogestrel. In this part of our series about NuvaRing we review some of the warnings about a woman's risk of developing blood clots found in the current NuvaRing Physician's Insert -- more g ...

NuvaRing Birth Control Device Can Cause Pulmonary Embolism, Deep Vein Thrombosis, Stroke, And Heart Attack: Part One 2007-08-28 17:36:06 Organon's Contraceptive Vaginal Ring Uses Etonogestrel, A Metabolite Of Dangerous Progestin Desogestrel (Posted by Tom Lamb at DrugInjuryWatch.com) NuvaRing is a contraceptive vaginal ring that was approved by the FDA in October 2001.  It is manufactured for sale in this country by Organon USA, Inc., based in New Jersey. NuvaRing has been linked to venous thromboembolic (VTE) events such as pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as ischemic stroke (CVA) and myocardial infarction (MI), or heart attack. To better understand this emerging drug safety problem, first one needs to know that NuvaRing is a combined contraceptive vaginal ring (CCVR). Ethinylestradiol, or ethinyl estradiol (EE), is the estrogen hormone component and etonogestrel is the progestin, or progestogen, hormone component of NuvaRing.  Over a three-week period, the NuvaRing birth control device releases 15 micrograms of ethinyl estradiol and 120 micrograms etonogestrel per day. As ...

NuvaRing Birth Control Device Can Cause Pulmonary Embolism, Deep Vein Thrombosis, Stroke, And Heart Attack: Part One 2007-08-28 17:36:06 Organon's Contraceptive Vaginal Ring Uses Etonogestrel, A Metabolite Of Dangerous Progestin Desogestrel (Posted by Tom Lamb at DrugInjuryWatch.com) NuvaRing is a contraceptive vaginal ring that was approved by the FDA in October 2001.  It is manufactured for sale in this country by Organon USA, Inc., based in New Jersey. NuvaRing has been linked to venous thromboembolic (VTE) events such as pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as ischemic stroke (CVA) and myocardial infarction (MI), or heart attack. To better understand this emerging drug safety problem, first one needs to know that NuvaRing is a combined contraceptive vaginal ring (CCVR). Ethinylestradiol, or ethinyl estradiol (EE), is the estrogen hormone component and etonogestrel is the progestin, or progestogen, hormone component of NuvaRing.  Over a three-week period, the NuvaRing birth control device releases 15 micrograms of ethinyl estradiol and 120 micrograms etonogestrel per day. As ...

Safety Of Trasylol Will Be Reviewed By FDA Advisory Panel In September 2007 2007-08-23 09:16:18 Will Consider Data Suggesting Trasylol Can Cause Kidney Damage, Heart Failure, and Death (Posted by Tom Lamb at DrugInjuryWatch.com) An August 22, 2007 article, "FDA panel will review Trasylol safety", published in the The Boston Globe informed that the FDA will convene an advisory committee of drug safety experts on September 12, 2007 to discuss Bayer AG's blood-clotting drug Trasylol.  The safety profile of Trasylol has been under FDA scrutiny for more than a year due to case reports which indicate that Trasylol may be associated with kidney damage and heart failure, including some patient deaths. Trasylol is used to reduce blood loss during coronary artery bypass surgery. In fact, the FDA held a similar advisory committee meeting in September 2006.  Thereafter, the FDA required Bayer to add safety warnings to the Trasylol package insert, or label, in late 2006 stating that doctors should only use Trasylol in patients who have an elevated risk of blood loss ...

Safety Of Trasylol Will Be Reviewed By FDA Advisory Panel In September 2007 2007-08-23 09:16:18 Will Consider Data Suggesting Trasylol Can Cause Kidney Damage, Heart Failure, and Death (Posted by Tom Lamb at DrugInjuryWatch.com) An August 22, 2007 article, "FDA panel will review Trasylol safety", published in the The Boston Globe informed that the FDA will convene an advisory committee of drug safety experts on September 12, 2007 to discuss Bayer AG's blood-clotting drug Trasylol.  The safety profile of Trasylol has been under FDA scrutiny for more than a year due to case reports which indicate that Trasylol may be associated with kidney damage and heart failure, including some patient deaths. Trasylol is used to reduce blood loss during coronary artery bypass surgery. In fact, the FDA held a similar advisory committee meeting in September 2006.  Thereafter, the FDA required Bayer to add safety warnings to the Trasylol package insert, or label, in late 2006 stating that doctors should only use Trasylol in patients who have an elevated risk of blood loss ...

New Book "Medication Errors" Is Subject Of A Good Review In NEJM 2007-08-21 10:26:45 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. Burke, M.D., of LDS Hospital in Salt Lake City, UT, which does a very good job of introducing us to a valuable new book, "Medication Errors", second edition, edited by Michael R. Cohen. As has been reported previously, the Institute of Medicine (IOM) estimates that at least 1.5 million Americans are sickened, injured, or killed each year by medication errors.  For this new book "Medication Errors", editor Michael R. Cohen -- a pharmacist and the president of the nonprofit Institute for Safe Medication Practices (ISMP), as well as a 2005 recipient of a John D. and Catherine T. MacArthur Foundation "genius grant" -- defines a medication error as "any preventable event that may cause or lead to inappropriate m ...

Parkinson's Disease Drug Permax Ordered Off The Market By Health Canada 2007-08-17 09:11:00 Permax Was Voluntarily Withdrawn From the U.S. Market Earlier This Year At The Insistence of FDA (Posted by Tom Lamb at DrugInjuryWatch.com)As you may recall, the Parkinson disease drug Permax was voluntarily withdrawn from the U.S. market in late March 2007 after studies in the New England Journal of Medicine underscored the increased risk of serious heart valve damage associated with Permax. In Canada, however, Eli Lilly Canada Inc. had continued to sell Permax (pergolide).  On August 16, 2007, however, Health Canada announced the sales of Permax must cease in their country as of August 30, 2007 In more detail, from a MedEffect Public Communication about Permax issued on August 16, 2007, we get this information about why Health Canada has taken this action: Two studies published in the New England Journal of Medicine (NEJM) in January 2007 showed that patients with Parkinson's disease who were treated with Permax had an increased chance of serious heart valve damage when ... Health

Off-Topic Message: BlawgWorld eBook Includes Drug Injury Watch For Second Year In A Row 2007-08-16 19:36:57 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 ...