Republished from Infomail 22/Jun/12 from NY USA charity AHRP [Alliance for Human Research Protection – www.ahrp.org]
“Prescription drug therapy stands as one of the most significant perils to health resulting from human activity.” Prescription drugs are the 4th leading cause of death in the US. In any given month, 48% of US consumers ingested a prescription drug, and 11% ingested five or more prescription drugs. Americans suffer from an estimated 45-50 million adverse effects, from prescription drugs–of which 2.5 million to 4 million are serious, disabling or fatal.
[QuarterWatch, May 2012 http://www.ismp.org/quarterwatch/pdfs/2011Q4.pdf]
The FDA does not even monitor its own adverse event report database, MedWatch. Neither government agencies charged with setting healthcare policies, nor major stakeholders in medicine, are monitoring drug safety to identify which prescribed drugs are causing most serious harm. No one in authority is doing anything to prevent the escalating number of preventable human casualties.
Only one in seven patented drugs offers a clinical benefit over existing, safer, and cheaper alternatives–and only 1% can be said to be “life-saving.” [http://www.pharmamyths.net/]
Since May, 2008, the Institute for Safe Medication Practices, an independent nonprofit organization, has been monitoring FDA’s MedWatch database, publishing quarterly reports (QuarterWatch). The latest report found that in 2011, the FDA received 179,855 reports of serious, disabling, and fatal adverse drug events in the United States. This is an increase of 9.4% from 2010. http://www.ismp.org/quarterwatch/pdfs/2011Q4.pdf
Pharmaceutical company reports about deaths were found to be “nearly useless” in that they are vague, failed to report critical patient information, such as cause of death or age of patient. Generic drug manufacturers rarely file adverse drug reports.
The authors—Thomas Moore, Curt Furberg, MD, PhD, and Michael Cohen, RPh, MS, ScD—point out that the most valuable barometer of drug safety risk is found in reports submitted directly to the FDA by physicians and patients. Unfortunately, the FDA estimates that serious adverse drug event reports submitted by physicians and patients constitute less than 1% of actual serious injuries. In 2011, physicians and patients submitted 21,002 adverse event reports to the FDA. These reports represent at least 2.5 million actual serious prescription drug injuries, including 128,000 deaths.
In 2011, the five leading drugs ranked by the number of direct adverse event reports from physicians or patients: anticoagulant drugs, Pradaxa and Coumadin linked to hemorrhage; antibiotic Levaquin linked to tendonitis, fatal allergic reaction, nerve damage resulting in pain, burning or numbness, and central nervous system abnormalities including depression, confusion; anti-cancer drug Carboplatin linked to bone marrow suppression; antihypertensive Lisinopril (Prinivil, Zestril) linked to dizziness, nausea, anxiety, insomnia, swelling, difficulty breathing.
The other valuable source of information documenting drug safety risk, are litigation-related adverse event reports submitted to the FDA. The five drugs most frequently cited in litigation were patent-protected: the anti-nausea drug metroclopramide linked to tardive dyskenisia; the contraceptive drugs Yaz and Yasmin linked to blood clots and stroke; the anti-diabetes drug Avandia linked to heart attacks; the anti-smoking drug Chantix linked to suicide and homicide; and the acne drug Accutane linked to suicide.
Fifty-eight drugs carry FDA-mandated warning labels about the risk of suicide and suicidal behaviors. The most frequently identified drug posing a suicide risk in 2011, was SEROQUEL, with 197 reported cases.
Since the Iraq war many troop deployments are only approved if medications are prescribed. The Los Angeles Times reported that service personnel can be given 180-days worth of pills to take to combat zones, with nothing to stop them trading medicines or grabbing handfuls of pills to dull a stressful day in the battlefield: Military’s Rising Psychiatric Drug Prescriptions May be Linked to Suicides, Homicides by Kim Murphy, The Los Angeles Times, Aptil 7, 2012.
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