{"id":206,"date":"2009-08-09T08:30:18","date_gmt":"2009-08-09T14:30:18","guid":{"rendered":"http:\/\/cchrstl.org\/wordpress\/?p=206"},"modified":"2024-07-14T05:43:45","modified_gmt":"2024-07-14T10:43:45","slug":"citizens-commission-on-human-rights-international-announces-fda-reported-psychiatric-drug-side-effects-search-engine","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2009\/08\/09\/citizens-commission-on-human-rights-international-announces-fda-reported-psychiatric-drug-side-effects-search-engine\/","title":{"rendered":"Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine"},"content":{"rendered":"<p align=\"center\"><em>Decrypted FDA reports reveal 4,260 suicides, 2,452 additional  deaths, 195 homicides from 2004-2006 alone<\/em><\/p>\n<p>Los Angeles, CA &#8212; For the first time the side effects of psychiatric drugs  that have been reported to the U.S. Food and Drug Administration (FDA) by  doctors, pharmacists, other health care providers and consumers have been  decrypted from the <a href=\"http:\/\/www.fda.gov\/medwatch\/\">FDA&#8217;s MedWatch <\/a>reporting system and been made available to the public in an easy to search  psychiatric drug side effects <a title=\"database and search engine\" href=\"http:\/\/www.cchrint.org\/psychdrugdangers\/\" target=\"_blank\" rel=\"noopener\">database and  search engine<\/a> (<a href=\"http:\/\/www.cchrint.org\/psychdrugdangers\/\">http:\/\/www.cchrint.org\/psychdrugdangers\/<\/a>).  The database is provided as a free public service by the mental health watchdog,  Citizens Commission on Human Rights International (CCHR).<\/p>\n<p>The report totals reveal that between 2004-2008 the FDA&#8217;s MedWatch system  received pregnancy-related psychiatric drug adverse reaction reports which  included 2,442 babies born with heart disease, 3,372 other birth defects, as  well as 1,072 miscarriages, abortions and other deaths.<\/p>\n<p>The database also reveals that, between 2004-2008 there were reports  submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309  homicides and 6,945 cases of diabetes from people taking psychiatric drugs.  These numbers reflect only a small percentage of the actual side effects  occurring in the consumer market, as the FDA has admitted that only 1-10% of  side effects are ever reported to the FDA.<\/p>\n<p>The database is searchable by individual reports (for the 2004-2006 period),  type of drug, age of patient, the side effect reported (suicide, homicide, heart  attack, stroke, mania, etc.), and whether the drug in question carries a black  box warning (the agency&#8217;s strongest warning&#8211;short of banning a drug).<\/p>\n<p>It is searchable by drug name and age group and includes who reported the  psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes  the top 20 reported adverse reactions to all psychiatric drugs to the FDA and  combined summaries of all psychiatric drug reactions for the years 2004-2006 and  2004-2008.<\/p>\n<p>Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads  for psychiatric and other drugs must include statements encouraging consumers to  report adverse drug reactions to the FDA&#8217;s MedWatch system&#8211;Adverse Events  Reporting System (AERS). However, consumers or doctors attempting to access the  AERS online were confounded by a system so complex that it was impossible to  use. Although the FDA should have made the information collected readily  accessible, it failed in that duty to the public. It took a computer programmer  over 1,000 hours to decipher four years&#8217; worth of data to make this information  available.<\/p>\n<p>The programmer identified the main psychiatric drugs in the AERS, wading  through quarterly reports of seven different reporting systems, including the  drug name, demographics, adverse reactions, patient outcomes, reporting source,  therapy start and end dates and the indication (diagnosis). The result: A  database and search engine that unravels the 94,000 pages of <a title=\"codified psychiatric drug adverse reactions\" href=\"http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/ucm082193.htm\" target=\"_blank\" rel=\"noopener\">codified psychiatric drug adverse reactions<\/a> reported each year  from 2004-2006 and 2004-2008 to the FDA&#8217;s MedWatch system.<\/p>\n<p>Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists,  other health care providers and consumers once those drugs are out in the  consumer market, is fundamental to drug safety monitoring. Yet these reports  have been frequently ignored or dismissed as &#8220;anecdotal&#8221; by the FDA even when  serious side effects number in the thousands. The FDA approves the majority of  psychiatric drugs only after Phase 2 (short term) clinical trials. However, once  the drugs are out in the consumer market, the FDA is supposed to require longer  clinical trials, or post-marketing studies of the drugs, however this rarely  happens. Subsequently, dangerous and deadly drugs have been left without black  box warnings, or on the market for far too long. The best &#8220;signal&#8221; event for the  FDA to direct its resources in identifying or pulling dangerous drugs is what is  happening out in the real world, with consumers and patients, not in a  controlled short term clinical trial, funded by the pharmaceutical companies  seeking approval for their drugs to go to market.<\/p>\n<p>For years the information contained in the FDA&#8217;s MedWatch reporting system  has been inaccessible and therefore virtually useless for consumers and doctors.  <a title=\"CCHR's\" href=\"http:\/\/www.cchrint.org\/\" target=\"_blank\" rel=\"noopener\">CCHR&#8217;s<\/a> stance  has always been that consumers have the right to this information for then &#8212;  and only then &#8212; can consumers have full &#8220;informed consent&#8221; regarding the risks  of psychiatric drugs, and so it has provided this database as a free public  service.<\/p>\n<p>The psychiatric drug search engine features a <a title=\"promotional video\" href=\"http:\/\/www.cchrint.org\/psychdrugdangers\/promo_video.html\" target=\"_blank\" rel=\"noopener\">promotional video<\/a> as well as an <a title=\"instructional video\" href=\"http:\/\/www.cchrint.org\/psychdrugdangers\/instructional_video.html\" target=\"_blank\" rel=\"noopener\">instructional video<\/a> for users on CCHR&#8217;s newly launched website  so they can get the information from the database they are looking for in the  shortest amount of time.<\/p>\n<p>About The Citizens Commission on Human Rights:<\/p>\n<p><a title=\"The Citizens Commission on Human Rights\" href=\"http:\/\/www.cchrint.org\/\" target=\"_blank\" rel=\"noopener\">The Citizens Commission on Human  Rights<\/a> is a mental health watchdog co-founded in 1969 by Professor of  Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a  non-profit, non political, non-religious organization that has been responsible  for more than 100 reforms that help protect patients rights against abuses in  the field of mental health. For more information about CCHR go to <a href=\"http:\/\/www.cchrint.org\/\" target=\"_blank\" rel=\"noopener\">http:\/\/www.cchrint.org<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA&#8217;s MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. <a href=\"https:\/\/www.cchrstl.org\/wordpress\/2009\/08\/09\/citizens-commission-on-human-rights-international-announces-fda-reported-psychiatric-drug-side-effects-search-engine\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2,3],"tags":[],"class_list":["post-206","post","type-post","status-publish","format-standard","hentry","category-big-muddy-river-newsletter","category-press-releases"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6NMpC-3k","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/206","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/comments?post=206"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/206\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=206"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=206"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}