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Articles from Drug Injury Watch

Debate Over Whether Zetia And Vytorin Are, In Fact, Effective Overshadows The Side Effects Of These Drugs 2008-02-06 17:04:00 Ezetimibe Component Of These Drugs Is Associated With Liver Failure, Acute Pancreatitis, Rhabdomyolysis, and Thrombocytopenia (Posted by Tom Lamb at DrugInjuryWatch.com) Ezetimibe is used alone (i.e., Zetia) or in combination with other antilipemic agents such as a statin or fenofibrate.  In some instances, ezetimibe is in fixed combination with simvastatin (i.e., Vytorin). Zetia and Vytorin are prescribed as an adjunct to dietary therapy in the treatment of primary hypercholesterolemia and mixed dyslipidemia, as well as homozygous familial hypercholesterolemia and/or homozygous familial sitosterolemia.  As is relatively well-known by now, however, the efficacy of Zetia and Vytorin was called into question when the results of the ENHANCE clinical study were finally released in January 2008 by Merck and Schering-Plough. For some recent developments concerning the ENHANCE study controversy as well as the related issue of whether Zetia and Vytorin are effective treatments, w ...

Medications Used For Epilepsy And Bipolar Disease Can Increase Risk Of Suicide And Suicidal Ideation 2008-02-05 09:19:00 FDA Will Convene Advisory Committee Meeting To Consider Whether Anti-Epileptic Drugs, Or Perhaps Epilepsy Itself, Associated With Increase In Suicidal Behaviors (Posted by Tom Lamb at DrugInjuryWatch.com) On January 31, 2008 the FDA issued a MedWatch email alert that stated: [T]he Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions.  The 11 anti-epileptic and psychiatric drugs that had been reviewed by the FDA were: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR); Felbamate (marketed as Felbatol); Gabapentin (marketed as Neurontin); Lamotrigine (marketed as Lamictal); Levetiracetam (marketed as Keppra); Oxcarbazepine (marketed as Trileptal); Pregabalin (marketed as Lyrica); Tiagabine (marketed as Gabitril); Topiramate (marketed as Topamax); Valproate (marketed as Depakote, Depakote ER, Depakene, Depac ...

Bisphosphonate-Induced Osteonecrosis And Osteomyelitis Of The Jaw Are Real Side Effects Of Drugs Like Fosamax 2008-02-01 16:53:53 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 Robert E. Marx, that was published in the medical journal Oral and Maxillofacial Surgery Clinics of North America.  A summary of the article sets the stage with this simple but true observation:Bisphosphonate-induced osteonecrosis of the jaws is the correct term for this real drug complication that most dental practitioners face. All nitrogen-containing bisphosphonates pose a risk, which is related to the route of administration, the potency of the bisphosphonate, and the duration of use. Next we look at an ite ...

Subpoenas Issued For Witnesses To Appear At February 2008 U.S. House Committee Hearing On Ketek 2008-01-29 17:13:52 Congress Wants To Know When Sanofi-Aventis And The FDA Learned About Fraud Involved With Ketek Study 3014 (Posted by Tom Lamb at DrugInjuryWatch.com) Soon after noon on January 29, 2008 Ed Silverman posted on his Pharmalot blog an article, "House Committee Will Subpoena FDA Over Ketek", which reported this breaking news about the Congressional investigation into Ketek, Sanofi-Aventis, and the FDA:At its hearing this morning, the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations voted unanimously to approve a motion to subpoena FDA officials and investigators over clinical trial data for the Sanofi-Aventis antibiotic [Ketek], which has been linked to liver failure.This same Pharmalot post about Ketek provided access to a January 25, 2008 memorandum sent by the committee's chairman, John Dingell, and Bart Stupak, the head of a subcommittee, both from Michigan, which had previewed the actions that would be taken at this January 29 meeting. ...

Avandia Label Is Getting Some Additional Contraindications And A New Warning In Europe 2008-01-24 16:00:52 January 2008 Revisions Follow An Avandia Safety Review That Was Completed By EMEA In October 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On January 24, 2008 GlaxoSmithKline (GSK) announced that the European label for its diabetes drug Avandia (rosiglitazone maleate) will be revised pursuant to a decision by the European Medicines Agency (EMEA)???s Committee for Medicinal Products for Human Use (CHMP). An article published by Reuters, "EU experts add new warnings to Glaxo's Avandia - UPDATE 1", reported what little was known about the Avandia label change in Europe as of noon EST on January 24:European regulators on Thursday recommended that patients with heart disease or leg pains -- a possible sign of heart problems -- should not take GlaxoSmithKline's (GSK.L: Quote, Profile, Research) diabetes drug Avandia. The European Medicines Agency also said in its decision to update Avandia's label that the drug must not be used by people having a heart attack or with cond ...

Avandia Label Is Getting Some Additional Contraindications And A New Warning In Europe 2008-01-24 16:00:52 January 2008 Revisions Follow An Avandia Safety Review That Was Completed By EMEA In October 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On January 24, 2008 GlaxoSmithKline (GSK) announced that the European label for its diabetes drug Avandia (rosiglitazone maleate) will be revised pursuant to a decision by the European Medicines Agency (EMEA)’s Committee for Medicinal Products for Human Use (CHMP). An article published by Reuters, "EU experts add new warnings to Glaxo's Avandia - UPDATE 1", reported what little was known about the Avandia label change in Europe as of noon EST on January 24:European regulators on Thursday recommended that patients with heart disease or leg pains -- a possible sign of heart problems -- should not take GlaxoSmithKline's (GSK.L: Quote, Profile, Research) diabetes drug Avandia. The European Medicines Agency also said in its decision to update Avandia's label that the drug must not be used by people having a heart attack or with cond ...

Reports Of Anti-Smoking Pill Chantix Causing Depression And Suicidal Ideation Made To FDA 2008-01-21 16:50:36 Pfizer Increases Warning About Abnormal Behavior Of Patients Using Its Smoking Cessation Medication In January 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On November 20, 2007 the FDA issued an "Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix)" to inform healthcare providers about reports the agency had received of people exhibiting various types of abnormal behaviors while using Chantix.  These reports included new-onset of depressed mood and suicidal ideation, as well as other unusual changes in emotion and behavior within days to weeks of initiating Chantix treatment. In that November 2007 Early Communication item regarding Pfizer Inc.'s anti-smoking pill Chantix, the FDA recommended the following measures: Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. Patients should use ca ...

Reports Of Anti-Smoking Pill Chantix Causing Depression And Suicidal Ideation Made To FDA 2008-01-21 16:50:36 Pfizer Increases Warning About Abnormal Behavior Of Patients Using Its Smoking Cessation Medication In January 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On November 20, 2007 the FDA issued an "Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix)" to inform healthcare providers about reports the agency had received of people exhibiting various types of abnormal behaviors while using Chantix.  These reports included new-onset of depressed mood and suicidal ideation, as well as other unusual changes in emotion and behavior within days to weeks of initiating Chantix treatment. In that November 2007 Early Communication item regarding Pfizer Inc.'s anti-smoking pill Chantix, the FDA recommended the following measures: Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. Patients should use ca ...

Blood-Clot Warning On Ortho Evra Birth Control Patch Increased, Again, In January 2008 2008-01-19 17:29:00 Label For "The Patch" No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) A January 18, 2008 WebMD article, "Stronger Warning for Birth Control Patch", provided a concise summary of the latest news about the Ortho Evra Contraceptive Transdermal (Skin) Patch manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson (JNJ):The FDA today strengthened its warning on the risk of serious blood clots in women using the Ortho Evra birth control skin patch. The warning about venous thromboembolism -- clots in veins that may be life-threatening if they travel to the lungs and cause pulmonary embolism -- isn't new. It's been on the Ortho Evra patch label since September 2006. What's new is that now, the patch's label no longer notes conflicting information about that risk. Previously, the Ortho Evra patch's label mentioned mixed results from two studies on clotting risk. One ...

Blood-Clot Warning On Ortho Evra Birth Control Patch Increased, Again, In January 2008 2008-01-19 17:29:00 Label For "The Patch" No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) A January 18, 2008 WebMD article, "Stronger Warning for Birth Control Patch", provided a concise summary of the latest news about the Ortho Evra Contraceptive Transdermal (Skin) Patch manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson (JNJ):The FDA today strengthened its warning on the risk of serious blood clots in women using the Ortho Evra birth control skin patch. The warning about venous thromboembolism -- clots in veins that may be life-threatening if they travel to the lungs and cause pulmonary embolism -- isn't new. It's been on the Ortho Evra patch label since September 2006. What's new is that now, the patch's label no longer notes conflicting information about that risk. Previously, the Ortho Evra patch's label mentioned mixed results from two studies on clotting risk. One ...

The FDA Aims To Improve Its Detection Of Drug Safety Signals 2008-01-16 13:37:58 Public Workshop On January 29, 2008 To Focus On Adverse Drug Reaction Reporting (Posted by Tom Lamb at DrugInjuryWatch.com) In recent years the FDA has been roundly criticized for its failure to timely recognize emerging drug safety issues. To improve its performance on this aspect of its work, the FDA is holding a public workshop as a means to look for ways by which to improve the collection of adverse event (AE) reports and the analysis of those reports for the purpose of better detecting drug safety "signals" in the future.  In more detail, this public workshop, “Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product’s Marketed Life Cycle”, will be held at The Conference Facility (terrace level) located at 5635 Fishers Lane, Rockville, MD 20857 on January 29, 2008, from 8:30 a.m. to 5 p.m., with seating on a first-come, first-served basis. A notice about this FDA public workshop published in the Federal Register, at 72 Fed. R ...

The FDA Aims To Improve Its Detection Of Drug Safety Signals 2008-01-16 13:37:58 Public Workshop On January 29, 2008 To Focus On Adverse Drug Reaction Reporting (Posted by Tom Lamb at DrugInjuryWatch.com) In recent years the FDA has been roundly criticized for its failure to timely recognize emerging drug safety issues. To improve its performance on this aspect of its work, the FDA is holding a public workshop as a means to look for ways by which to improve the collection of adverse event (AE) reports and the analysis of those reports for the purpose of better detecting drug safety "signals" in the future.  In more detail, this public workshop, ???Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product???s Marketed Life Cycle???, will be held at The Conference Facility (terrace level) located at 5635 Fishers Lane, Rockville, MD 20857 on January 29, 2008, from 8:30 a.m. to 5 p.m., with seating on a first-come, first-served basis. A notice about this FDA public workshop published in the Federal Register, at 72 Fed. R ...

Zetia And Vytorin: Steven Nissen Calls For A "Moratorium" On Their Use Due To Failed Study 2008-01-14 10:49:03 Long-Awaited Results Of ENHANCE Study Show Zocor + Zetia (= Vytorin) Does Not Improve Patient Outcomes (Posted by Tom Lamb at DrugInjuryWatch.com) A January 14, 2008 Bloomberg article, "Merck, Schering's Vytorin No Better Than Generic (Update 2)", reported the long-awaited results of a study concerning Zetia and Vytorin as well as the immediate fall-out:  Merck & Co. and Schering-Plough Corp. said their combination cholesterol drug Vytorin worked no better than an older, generic medication in reducing the buildup of artery-clogging fat in a key study. Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, immediately called for a "moratorium" on the use of Vytorin and Zetia. Vytorin is a combination of Zetia and simvastatin, the generic medication used in the trial. The two cholesterol drugs generated $1.3 billion in third-quarter sales.... "In the absence of any evidence of a clinical benefit, these drugs should now be used as a las ...

Zetia And Vytorin: Steven Nissen Calls For A "Moratorium" On Their Use Due To Failed Study 2008-01-14 10:49:03 Long-Awaited Results Of ENHANCE Study Show Zocor + Zetia (= Vytorin) Does Not Improve Patient Outcomes (Posted by Tom Lamb at DrugInjuryWatch.com) A January 14, 2008 Bloomberg article, "Merck, Schering's Vytorin No Better Than Generic (Update 2)", reported the long-awaited results of a study concerning Zetia and Vytorin as well as the immediate fall-out:  Merck & Co. and Schering-Plough Corp. said their combination cholesterol drug Vytorin worked no better than an older, generic medication in reducing the buildup of artery-clogging fat in a key study. Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, immediately called for a "moratorium" on the use of Vytorin and Zetia. Vytorin is a combination of Zetia and simvastatin, the generic medication used in the trial. The two cholesterol drugs generated $1.3 billion in third-quarter sales.... "In the absence of any evidence of a clinical benefit, these drugs should now be used as a las ...

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