Fwd: QuarterWatch: 1, 000 + deaths -- Digoxin_ Suicide/ Violence -- Chantix

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ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org  FYIThe latest QuarterWatch report (May 7, 2009) by the Institute for SafeMedication Practices (ISMP) found the following disturbing trends during thethird Quarter of 2008: * During the third quarter of 2008 the FDA received 24,872 serious adversedrug event reports identifying 854 different drugs.  For the third quarter of 2008 reported serious, disabling adverse drugevents were 30.5% higher than the same quarter one year ago.The cases described 2778 patient deaths, 1162 cases of disability and 20,932cases of other kinds of serious injury.Reported patient deaths in the third quarter were 41% higher than the samequarter in the previous year.*More than 1,000 patient deaths have been reported in connection with therecall of the heart drug digoxin, but a year later no testing has beenperformed to determine how many are directly linked to defective tablets."*More than 100 cases of serious injuries were reported in connection with amuscle relaxant (Lioresal Intrathecal) that is delivered to the spinal fluidthrough an implanted pump."Bear in mind that the adverse drug events reported to the FDA isminiscule--estimated at between 1% and 10% of the actual adverse eventsrelated to FDA-approved, marketed prescription drugs. That should, but hasnot, prompted the FDA to take timely action when a significant number ofserious adverse effects are reported about a particular drug.1,000 DIGOXIN DEATHS:  The ISMP report shows that even as more than 1000 patient deaths have nowbeen reported in connection with the recall of 800 million Digoxin tablets manufactured bythe Actavis Group,one year after the announcement of the recall, no testing of returnedtablets has been performed to establish how many of these deaths resulted from a manufacturing defect,and how many might have resulted from other safety problems.The tablets were recalled because of the possibility that the strength oftablets was greater than labeled and might provide a potentially lethal overdose to patientstaking the drug to aid failing hearts. Furthermore, a new recall of digoxin tablets in March 2009 from anothermanufacturer-Caraco Pharmaceutical Laboratories-underlines weaknesses inthe U.S. system for insuring quality control in the manufacture of genericdrugs.This problem has received little public or official notice in part becausethe FDA does not require that the size of the product recall be disclosed. And the size can vary from afew thousand tablets to nearly a billion. As a consequence of FDA's failure to warn about the scope of the recall,doctors don't have a clue, and patients who had filled prescriptions prior to the recall are beingkilled by defective pills.Varenicline (CHANTIX, CHAMPIX) CASE REPORTS LINKED TO SUICIDE AND VIOLENCE: This drug, prescribed to help people stop smoking, continued to ACCOUNT FORMORE REPORTS OF SERIOUS PSYCHIATRIC SIDE EFFECTS than any other prescription drug. Since Chantix approval, QuarterWatch identified 30 possible cases reportingphysical ASSAULT,148 cases mentioning homicidal thoughts and 331 cases of behavior describedas aggression.The FDA has failed to require prominent warnings about the assaultivebehavior triggered by Chantix.The authors, Thomas J. Moore, Senior Scientist, Drug Safety and Policy,ISMP, Michael R. Cohen, President, ISMPCurt D. Furberg, MD, PhD, Professor of Public Health Sciences, Wake ForestUniversity School of Medicine,recommend that the Medication Guide for varenicline (Chantix) should bestrengthened to include warnings about risk of vehicle and other accidents, and of psychiatric side effects involvingaggression and violence towards others.The authors discovered a system-wide error in how case reports were beingcoded as "initial" or "follow up." Numerous reports were coded as "follow up" when  there was no record of aninitial report having ever been received.Some drug manufacturers are using many different names to identify the samedrug product in reports submitted in the same quarter. For example, we foundone company used 11 different names to describe the drug product leuprolide.Contact: Vera Hassner Sharavveracare212-595-8974EXCERPT: The authors' conclusion:"It is increasingly clear that the nation is experiencing serious problemsin insuringthat generic drugs are manufactured with adequate quality control. In thefirst quarter of2008, there were large urgent recalls of most of the nation's supply of oneform of thedrug heparin 2 and of millions of fentanyl patches from several drugmanufacturers. 3 Inthe second quarter, about 50% of the nation's unexpired supply of digoxinwas recalledbecause of potential over strength tablets, and an additional digoxin recallwas announcedin March 2009. In the third and fourth quarters of 2008, additional urgentrecalls wereannounced for morphine sulfate, propafenone, and isosorbide-all drugs whereover orunder strength tablets could have significant health consequences. 4 Inaddition, twoNew Jersey plants of the Actavis Group were closed because of manufacturingproblems,and all products manufactured there recalled. In December 2008 KVPharmaceuticals'plants were closed to resolve quality control problems. This problem has received little public or official notice in part becausethe FDAdoes not require that the size of the product recall be disclosed. It canvary from a fewthousand tablets to nearly a billion. For example, neither CaracoPharmaceuticalLaboratories nor the FDA would reveal how many digoxin tablets were involvedin itsMarch 31, 2009 recall notice.6 The FDA's current system for inspectingplants, dealingwith violations and managing product recall notices requires systematicindependentreview.We continue to be concerned about the safety profile of varenicline(Chantix)which continues to account for more psychiatric side effects reported to theFDA thanany other prescription drug. In this report we focus on reports of violencetowards otherswhich are not adequately described in the current Medication Guide forpatients. Inaddition, no action has been taken to provide a prominent warning about thepotential ofvarenicline to cause motor vehicle and other types of accidents through itseffects onmood, memory, vision and motor control."See, full ISMP QuaterWatch report at:http://www.ismp.org/QuarterWatch/2008Q1.pdf_____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.