{"id":62413,"date":"2015-08-17T12:00:00","date_gmt":"2015-08-17T11:00:00","guid":{"rendered":"https:\/\/www.transcend.org\/tms\/?p=62413"},"modified":"2015-08-12T11:44:12","modified_gmt":"2015-08-12T10:44:12","slug":"warnings-for-patients-taking-psych-drugs-also-for-their-families-and-prescribing-practitioners","status":"publish","type":"post","link":"https:\/\/www.transcend.org\/tms\/2015\/08\/warnings-for-patients-taking-psych-drugs-also-for-their-families-and-prescribing-practitioners\/","title":{"rendered":"Warnings for Patients Taking Psych Drugs &#8211; Also for Their Families and Prescribing Practitioners"},"content":{"rendered":"<p style=\"text-align: left;\">Over the years, I have formally taught my patients (as well as many participants in my lectures and seminars) about the un-advertised dangers of psychiatric medications &#8211; especially the long-term brain alterations and drug-dependencies that drug companies don\u2019t test for before the FDA grants them marketing approval.<\/p>\n<p style=\"text-align: left;\">Since my retirement from my holistic, non-drug, mental healthcare practice, I have continued to issue written warnings about the multitude of serious, sometimes even lethal, albeit unintended (and untested for), adverse consequences of taking psychiatric drugs, especially over the long-term.<\/p>\n<p style=\"text-align: left;\">My warnings have usually been directed at my fellow healthcare practitioners, nurses, social workers, clergypersons, journalists, legislators, various industry groups, and the public in general, but there seems to have been no audible response from most of them concerning the dangers to the very people that these professions are supposed to be caring for.<\/p>\n<p style=\"text-align: left;\">The information that I have relied on to treat my (subtly or overtly) drug-intoxicated patients came from many sources. Among those sources were 1) various peer-reviewed (albeit obscure) neuroscience journals, 2) whistle-blowing (and therefore often ostracized) psychiatrists, physicians, neuroscientists and medical journalists, and 3) my own extensive research into the basic neuroscience literature (which I had never had time to read as a busy family practitioner &#8211; barely having time to read the drug-industry-approved and subsidized mainstream medical journals).<\/p>\n<p style=\"text-align: left;\">In my Duty to Warn columns, I have often written about my concerns for the victims of brain-altering drugs, who, in my professional experience, had become dependent on (addicted to) any number of neurotoxic and psychotoxic drugs that Big Pharma had falsely assured me were not addictive.<\/p>\n<p style=\"text-align: left;\">Ignoring the essential reality about drug dependency and toxicity has caused many psychiatric patients (and their prescribing practitioners) to miss the fact that when the patients ran out of their meds or attempted to quit the drugs that were sickening them, they often became ill with entirely new symptoms that were the reasons for starting the drugs. (Quitting a psych drug can be as medically hazardous as starting one.)<\/p>\n<p style=\"text-align: left;\">The withdrawal symptoms that my patients experienced were always different from the symptoms that prompted the initial prescriptions, and they had been uniformly mis-diagnosed as a \u201crecurrence\u201d of the so-called \u201cmental illness\u201d, and therefore the offending drugs had usually been restarted, usually at higher doses, often with additional new drugs being added to counteract the new withdrawal symptoms.<\/p>\n<p style=\"text-align: left;\">I have also tried to alert the public, especially the media, about the epidemic of mass shootings that have been perpetrated by shooters whose brains, cognition and behaviors had been altered by psychiatric drugs. The mainstream media, not wanting to implicate the drug companies that advertise with them, prefer to demonize the folks that had been made \u201cmentally ill\u201d by the toxic culture rather than to the toxic drugs that can cause normal stressed-out, sleep-deprived and brain-malnourished folks, including the scores of male adolescent school shooters, to act like they are mentally ill.<\/p>\n<p style=\"text-align: left;\">Nevertheless, even medical journalists, especially those writing for major media outlets, have refused to even hint at (or been forbidden to write about by their editors or publishers) the strong connections between psychiatric drug intoxication and the epidemic of mass murder\/suicide that continue to (intentionally?) confuse everybody. And so the shootings continue and the drug-marketers, drug-prescribers and other drug-profiteers continue risking the public health; and they continue getting off scot-free, never being charged as accomplices to the crimes. Just witness the pathetic failure of the defense attorneys for the Zoloft-intoxicated (150 mg per day!!) and Klonopin-intoxicated Batman Shooter from mounting a logical defense that could easily have convinced any intelligent jury to declare James Holmes of being \u201cguilty\u201d but temporarily insane because of his psychiatric drug-intoxication.<\/p>\n<p style=\"text-align: left;\">I attach below an important document from the Citizens Commission for Human Rights (<a target=\"_blank\" href=\"http:\/\/www.cchrint.org\" >www.cchrint.org<\/a>) that contains vitally important information for readers who may be justifiably concerned about the potential consequences of the long-term use of psych drugs by their loved ones. It is highly likely that many psychiatrists, family practitioners, internists, pediatricians and nurse practitioners are not yet fully aware of the prescription drug dangers listed below and therefore will not have issued adequate warnings about the drugs.<\/p>\n<p style=\"text-align: left;\">Even though the incidence of the most dramatic dangers of psych drug-induced aberrant behaviors (including murder, suicide, psychotic behavior, criminality, aggression) are not necessarily frequent, the less serious adverse effects of drug-induced \u201cmental illnesses\u201d are common.<\/p>\n<p style=\"text-align: left;\">Those common adverse effects of psych drugs that can mimic mental illnesses are listed below and include increased depression, increased anxiety, mania, akathisia, suicidality, agitation, lack of empathy, fatigue and tiredness, insomnia (or somnolence), memory loss, diabetes, weight gain (or weight loss), loss of IQ points, etc.<\/p>\n<p style=\"text-align: left;\">If the readers of this warning recognize the validity of the statements below (or in the various Duty to Warn columns I have written in the past &#8211; please draw the attention of prescribing practitioners to the information. Perhaps he or she will become more aware of the serious dangers of the chronic use of brain-altering drugs. Perhaps such actions will prevent the next suicide attempt or the next mass shooting incident. (Warning: Patients who are already on such drugs are warned to not suddenly quit their drugs cold-turkey and to consult with their prescribing physicians to discuss the information above and below. There are compassionate practitioners who understand the neuroscience of addiction, drug withdrawal and brain nutrition that might be willing to help patients get through the inevitable withdrawal symptoms that commonly occur during what is ideally a slow tapering process.<\/p>\n<p style=\"text-align: left;\">Here is the article which is excerpted, with permission, from CCHR\u2019s website. It details 22 regulatory warnings about drug dangers from various agencies around the world. We physicians were supposed to officially receive such warnings. (The documentation of each of the warnings can be found at the CCHR website or at the Duluth Reader website at (http:\/\/duluthreader.com\/articles\/categories\/200_Duty_to_Warn)<\/p>\n<p style=\"text-align: left;\"><strong>Psychiatric Drugs\u2014Regulatory Warnings on Violence, Mania, Psychosis, Homicide<\/strong><\/p>\n<p style=\"text-align: left;\"><a target=\"_blank\" href=\"http:\/\/www.cchrint.org\/psychiatric-drugs\/drug_warnings_on_violence\/\" >http:\/\/www.cchrint.org\/psychiatric-drugs\/drug_warnings_on_violence\/<\/a><\/p>\n<p style=\"text-align: left;\"><strong>Fact:\u00a0<\/strong>Despite 22 international drug regulatory warnings on psychiatric drugs citing effects of mania, hostility, violence and even homicidal ideation, and dozens of high profile shootings\/killings tied to psychiatric drug use, there has yet to be a federal investigation on the link between psychiatric drugs and acts of senseless violence.<\/p>\n<p style=\"text-align: left;\"><strong>Fact:\u00a0<\/strong>Between 2004 and 2012, there have been 14,773 reports to the U.S. FDA\u2019s MedWatch system on psychiatric drugs causing violent side effects including: 1,531 cases of homicidal ideation\/homicide, 3,287 cases of mania &amp; 8,219 cases of aggression.\u00a0Note: \u00a0The FDA estimates that less than 1% of all serious events are ever reported to it, so the actual number of side effects occurring are most certainly higher<strong>.<\/strong><\/p>\n<p style=\"text-align: left;\">School-related acts of violence aren\u2019t the only cases commonly found to\u00a0be under the influence of psychiatric drugs.\u00a0 There are\u00a0<a target=\"_blank\" href=\"http:\/\/www.cchrint.org\/psychiatric-drugs\/drug_warnings_on_violence\/recent-murdersmurder-suicides\/\" >18 other recent\u00a0acts of senseless violence committed by individuals taking or withdrawing from psychiatric drugs<\/a>\u00a0resulting in\u00a0an additional 76 dead and 61 wounded.<\/p>\n<p style=\"text-align: left;\">\u00a0<strong>To read all drug regulatory agency warnings &amp; studies on psychiatric drugs<\/strong><strong>,\u00a0<\/strong>visit CCHR\u2019s\u00a0<a target=\"_blank\" href=\"http:\/\/www.cchrint.org\/psychdrugdangers\" >Psychiatric Drug Side Effects Search Engine.<\/a><\/p>\n<p style=\"text-align: left;\"><strong>The Drug Regulatory Agency Warnings on Psychiatric drugs and Violence<\/strong><\/p>\n<p style=\"text-align: left;\"><strong><u>United States, November 2005:<\/u><\/strong>\u00a0 The FDA\u2019s Safety Information and Adverse Event Reporting Program reported \u201c<strong>homicidal ideation<\/strong>\u201c as an adverse event of\u00a0<strong>Pfizer\u2019s<\/strong> <strong>Effexor<\/strong>\u00a0<strong>ER<\/strong> (extended release). (Source: \u201cDetailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) \u2014 November 2005,\u201d FDA MedWatch, November 2005.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, March 22, 2004<\/u><\/strong><u>:<\/u>\u00a0 The FDA Public Health Advisory was issued, on\u00a0<strong>antidepressants<\/strong><strong>\u00a0<\/strong>stating: \u201c<strong>Anxiety<\/strong>,\u00a0<strong>agitation<\/strong>,\u00a0panic attacks, insomnia, <strong>irritability<\/strong>,\u00a0<strong>hostility<\/strong>, impulsivity,\u00a0<strong>akathisia [severe restlessness]<\/strong>, <strong>hypomania [abnormal excitement, mild mania]<\/strong>\u00a0and\u00a0<strong>mania<\/strong>\u00a0[psychosis characterized by exalted feelings, delusions of grandeur and overproduction of ideas], have been reported in adult and pediatric patients being treated with antidepressants.\u201d (Source: \u201cWorsening depression and suicidality in patients being treated with antidepressant medications,\u201d FDA Public Health Advisory, 22 Mar. 2004.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, October 1995<\/u><\/strong><u>:<\/u><strong>\u00a0\u00a0<\/strong>The U.S. Drug Enforcement Administration (DEA) said\u00a0<strong>Novartis\u2019s Ritalin<\/strong>\u00a0use could lead to addiction and that \u201c<strong>psychotic episodes<\/strong>, <strong>violent behavior<\/strong>\u00a0and\u00a0<strong>bizarre mannerisms<\/strong>\u00a0had been reported\u201d with its abuse. (Source: \u201cMethylphenidate,\u201d U.S. Drug Enforcement Administration (DEA), October 1995. <strong>McNeil\u2019s \u00a0Concerta<\/strong>\u00a0and other methylphenidate (<strong>Novartis\u2019s Ritalin<\/strong>) products (stimulants) to include, \u201cpsychiatric events such as visual hallucinations,\u00a0<strong>suicidal ideation<\/strong>,\u00a0<strong>psychotic behavior<\/strong>, as well as\u00a0<strong>aggression<\/strong>\u00a0or\u00a0<strong>violent behavior<\/strong>.\u201d The FDA announced its intention to also investigate possible cardiac concerns with these drugs. (Source: \u201cStatement on Concerta and Methylphenidate for the June 30 PAC\u201d, Food and Drug Administration (FDA), June 2005.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Canada, February 2006<\/u><\/strong><u>:<\/u>\u00a0 Health Canada approved a new warning label for <strong>GlaxoSmithKline\u2019s Paxil<\/strong>\u00a0that read, in part: \u201cA small number of patients taking drugs of this type may feel worse instead of better. For example, they may experience\u00a0<strong>unusual feelings of agitation<\/strong>,\u00a0<strong>hostility or anxiety<\/strong>, or have\u00a0<strong>impulsive or disturbing thoughts, such as thoughts of self-harm or harm to others.<\/strong><strong>\u201d<\/strong>\u00a0 Health Canada required Paxil\u2019s product information to detail a list of \u201crare\u201d side effects, affecting fewer than one in 1,000 patients. These include <strong>delusions,<\/strong>\u00a0<strong>hostility<\/strong>, <strong>psychosis<\/strong>, and\u00a0<strong>psychotic depression<\/strong>.\u00a0 (Source: Kate Jaimet, \u201c\u2019I\u2019ve learned a lesson in the worst way possible&#8217;: What drove a loving father to kill his son?\u201d Ottawa Citizen, 27 Aug. 2006.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Canada, June 03, 2004<\/u><\/strong><u>:<\/u>\u00a0 Health Canada issued an advisory to the public that stated that stronger warnings have been placed on\u00a0<strong>antidepressants<\/strong>. These warnings indicate that people taking these drugs at any age are at greater risk of behavioral or emotional changes including\u00a0<strong>self-harm<\/strong>\u00a0or\u00a0<strong>harm to others<\/strong>.\u00a0The advisory said, \u201cA small number of patients taking drugs of this type may feel worse instead of better\u2026. For example, they may experience unusual feelings of <strong>agitation<\/strong>,\u00a0<strong>hostility<\/strong>\u00a0or\u00a0<strong>anxiety<\/strong>,\u00a0or have\u00a0<strong>impulsive or disturbing thoughts that could involve self-harm or harm to others<\/strong>.\u201d (Source: Jirina Vlk, \u201cHealth Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants,\u201d Health Canada, 2004-31, June 3, 2004.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Japan, May 2009:<\/u><\/strong><strong>\u00a0<\/strong>\u00a0The Japanese Ministry of Health, Labor and Welfare investigated news reports of\u00a0<strong>antidepressant<\/strong>\u00a0users \u201cwho developed increased feelings of\u00a0<strong>hostility<\/strong>\u00a0or\u00a0<strong>anxiety<\/strong>, and have even committed\u00a0<strong>sudden acts of violence<\/strong>\u00a0against others.\u201d After its investigation, the Ministry decided to revise the label warnings on newer antidepressants stating, \u201cThere are cases where we cannot rule out a causal relationship [of\u00a0<strong>hostility<\/strong>,\u00a0<strong>anxiety<\/strong>, and\u00a0<strong>sudden acts of violence<\/strong>] with the medication.\u201d (Source: \u201cJapan Revises SSRI Warnings\u2013Hostility, Violence,\u201d Medical News Today, May 28, 2009.)<\/p>\n<p style=\"text-align: left;\"><strong><u>European Union, August 19, 2005:<\/u><\/strong>\u00a0 The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child\u00a0<strong>antidepressant<\/strong>\u00a0use as recommended by Europe\u2019s Committee for Medicinal Products for Human Use (CHMP). Clinical trials had shown that the drugs caused\u00a0<strong>suicidal behavior<\/strong>\u00a0including\u00a0<strong>suicide attempts<\/strong>\u00a0and\u00a0<strong>suicidal ideation,<\/strong>\u00a0<strong>aggression<\/strong>,\u00a0<strong>hostility (predominantly aggression, oppositional behavior and anger<\/strong><strong>)<\/strong>\u00a0and\/or related behaviors. (Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001\/83\/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Australia, February 2009:<\/u><\/strong>\u00a0 The Australian Therapeutic Goods Administration reported that a boxed warning (the strongest warning) was placed onto the ADHD psychostimulant drug <strong>methylphenidate<\/strong> (<strong>Concerta and Ritalin<\/strong>) for drug dependence. It warns that chronic abuse of <strong>methylphenidate<\/strong> can lead to a marked tolerance and psychological dependence with varying degrees of <strong>abnormal behavior<\/strong>\u00a0and\u00a0<strong>frank psychotic episodes<\/strong>\u00a0can also occur. (Source: \u201cBoxed Warning, Contraindications and strengthened Precautions for Methylphenidate,\u201d Janssen-Cilag, February 2009.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Australia, December 2004<\/u><\/strong><u>:<\/u>\u00a0 The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin recommending that any use of SSRI\u00a0<strong>antidepressants<\/strong>\u00a0in children and adolescents should be carefully monitored for the emergence of\u00a0<strong>suicidal ideation<\/strong>.\u00a0 In a recent study involving <strong>Eli Lilly\u2019s<\/strong> <strong>Prozac<\/strong>, it said, there was an increase in adverse psychiatric events of\u00a0<strong>suicide<\/strong>, <strong>self-harm<\/strong>,\u00a0<strong>aggression<\/strong>\u00a0and\u00a0<strong>violence<\/strong>. (Source: \u201cUse of antidepressants in children and adolescents,\u201d The Australian Therapeutic Goods Administration (TGA) published an Adverse Drug Reactions Bulletin, Vol 23, No. 6, Dec. 2004, p. 22.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, July 01, 2009<\/u><\/strong><u>:<\/u>\u00a0 The FDA has required the manufacturers of the smoking cessation aids <strong>varenicline<\/strong> (<strong>Pfizer\u2019s Chantix)<\/strong> and <strong>bupropion (GlaxoSmithKline\u2019s<\/strong> <strong>Zyban<\/strong><strong>,<\/strong> aka the antidepressant\u00a0<strong>GlaxoSmithKline\u2019s<\/strong> <strong>Wellbutrin<\/strong>) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include <strong>changes in behavior, hostility,\u00a0agitation, depressed mood,\u00a0suicidal thoughts and behavior<\/strong>, and <strong>attempted suicide<\/strong>. (Source: \u201cInformation for Healthcare Professionals: <strong>Varenicline<\/strong> (marketed as <strong>Chantix<\/strong>) and <strong>Bupropion<\/strong> (marketed as <strong>Zyban, Wellbutrin<\/strong>, and generics),\u201d FDA, July 1, 2009.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United Kingdom, March 2009:<\/u><\/strong>\u00a0 Medicines and Healthcare products Regulatory Agency (UK) published in their Drug Safety Update newsletter new information about <strong>Atomoxetine<\/strong> (<strong>Eli Lilly\u2019s<\/strong> <strong>Strattera<\/strong>, a <em>[alleged]<\/em> \u201cnon-stimulant\u201d ADHD drug). They warned that <strong>Strattera<\/strong> is associated with\u00a0<strong>treatment-emergent psychotic or manic symptoms<\/strong>\u00a0in children without a history of such disorders. (Source: Medicines and Healthcare products Regulatory Agency, Drug Safety Update newsletter, Vol. 2, March 8, 2009.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Australia, December 2008:<\/u><\/strong><strong>\u00a0<\/strong>\u00a0The Australian Adverse Drug Reactions Bulletin published an article about the<strong>\u00a0(<\/strong><strong>Cephalon\u2019s psychostimulant<\/strong>\u00a0 <strong>Provigil<\/strong> (<strong>modafinil)<\/strong>. The bulletin advised that this drug has been reported to cause serious adverse skin and psychiatric reactions including\u00a0<strong>anxiety, hallucination, aggression<\/strong>, and\u00a0<strong>mania<\/strong>. (Source: Adverse Drug Reactions Advisory Committee, Australian Adverse Drug Reactions Bulletin, Vol. 27, No. 6, December 2008.)<\/p>\n<p style=\"text-align: left;\"><strong><u>European Union, November 20, 2008:<\/u><\/strong><strong>\u00a0<\/strong>\u00a0<strong>Eli Lilly<\/strong> included in their <strong>Strattera<\/strong> label in Europe warnings that\u00a0<strong>Strattera<\/strong>\u00a0causes \u201c<strong>hallucinations, delusional thinking,<\/strong> <strong>mania<\/strong>\u00a0or\u00a0<strong>agitation<\/strong>\u00a0in children and adolescents without a prior history of psychotic illness or mania\u2026\u201d <strong>Strattera<\/strong> is an \u201cantidepressant\u201d prescribed as a \u201cnon-stimulant\u201d drug to treat ADHD. (Source: \u201cOfficial warnings issued: The ADHD drug <strong>Strattera<\/strong> CAUSES psychosis, hallucinations, mania and agitation\u201d TransWorldNews, November 20, 2008.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, September 2007:<\/u><\/strong><strong>\u00a0<\/strong>\u00a0The Vice President of Medical Services at the drug company <strong>Cephalon<\/strong> sent out a letter to health care professionals informing them of new warnings for the company\u2019s \u00a0<strong>psychostimulant\u00a0 Provigil<\/strong>. \u201cUpdated Safety Information: Warnings regarding serious rash, including Stevens Johnson Syndrome [a life-threatening condition affecting the skin] and hypersensitivity reactions, and psychiatric symptoms (including\u00a0<strong>anxiety<\/strong>,\u00a0<strong>mania<\/strong>, <strong>hallucinations, and suicidal ideation<\/strong>). 1. <strong>Provigil<\/strong> can cause life-threatening skin and other serious hypersensitivity reactions\u2026 2. <strong>Provigil<\/strong> is not approved for use in pediatric patients for any indication. 3. <strong>Provigil<\/strong> can cause psychiatric symptoms.\u201d (Source: Jeffrey M. Dayno, M.D., \u201cDear Healthcare Professional,\u201d Cephalon, September 2007.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, February 21, 2007:<\/u><\/strong>\u00a0 The FDA directed\u00a0<strong>ADHD drug <\/strong>manufacturers to distribute \u201cpatient friendly\u201d guides to consumers warning about <strong>serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions<\/strong> caused by ADHD drugs.\u00a0\u00a0 The psychiatric adverse events included<strong> hearing voices, becoming suspicious for no reason<\/strong>, or <strong>becoming manic<\/strong>, even in patients who did not have previous psychiatric problems. (Source: \u201cFDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events,\u201d FDA News, February 21, 2007.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, August 21, 2006:<\/u><\/strong>\u00a0 The FDA said that\u00a0<strong>ADHD drug <\/strong>manufacturers have to strengthen their warning labels to warn that the drugs can cause <strong>suppression of growth,\u00a0psychosis, bipolar illness, \u00a0aggression<\/strong>, \u00a0and <strong>\u2018serious\u2019 cardiovascular side effects<\/strong>, including misuse possibly leading to sudden death from heart attacks and strokes. Psychostimulant drug companies <strong>GlaxoSmithKline and Shire (makers of Adderall and Vyvanase) <\/strong>posted a letter to doctors about the revised prescribing information. (Source: \u201cUPDATE 2-US FDA calls for new warnings on ADHD drugs\u201d, Reuters, August 21, 2006.)<\/p>\n<p style=\"text-align: left;\"><strong><u>European Union, April 25, 2005:<\/u><\/strong><strong>\u00a0<\/strong>\u00a0The European Medicines Agency\u2019s scientific committee, the Committee for Medicinal Products for Human Use, concluded that\u00a0<strong>Prozac-type antidepressants<\/strong><strong>\u00a0<\/strong>were associated with <strong>increased suicide-related behavior<\/strong>\u00a0and\u00a0<strong>hostility<\/strong>\u00a0in young people. The London-based watchdog said it recommended the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks and that the drugs should not be used in children and adolescents in off label situations. (Source: \u201cEU calls for tougher warnings on antidepressants for kids\u201d News-Medical.net April 25, 2005.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United Kingdom, September 21, 2004:<\/u><\/strong>\u00a0 The British Healthcare Products Regulatory Authority advised that it had issued guidelines that children should not be given most <strong>SSRI antidepressants<\/strong> because of clinical trial data showing an increase rate of harmful outcomes, including\u00a0<strong>hostility<\/strong>. (Source: \u201cAntidepressant aggression concern,\u201d BBC News, 21 Sept. 2004.)<\/p>\n<p style=\"text-align: left;\"><strong><u>European Union, April 22, 2004<\/u><\/strong><u>:<\/u>\u00a0 The European Agency for the Evaluation of Medicinal Products issued a press release to the press and public. In this press release, they reported that, according to clinical trials, <strong>GlaxoSmithKline\u2019sparoxetine<\/strong>\u00a0(<strong>Paxil<\/strong>\u00a0in the U.S.)\u00a0containing medicines could cause\u00a0<strong>suicidal behavior<\/strong>\u00a0 and\u00a0 <strong>hostility<\/strong>\u00a0in children. It recommended that <strong>paroxetine<\/strong> not be used in children and recommended that young adults be observed carefully for signs and symptoms of\u00a0<strong>suicidal behavior <\/strong><strong>or\u00a0 hostility. Paroxetine<\/strong> was shown to have little effectiveness in children according to clinical trials. The committee also recommended <strong>strengthened warnings on the withdrawal symptoms of paroxetine, which are common. <\/strong>(Source: \u201cEuropean Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products 20-22 April 2004\u2033 EMEA, The European Agency for the Evaluation of Medicinal Products, Press Release April 2004.)<\/p>\n<p style=\"text-align: left;\"><strong><u>Canada, August 22, 2003:<\/u><\/strong>\u00a0 <strong>Wyeth Pharmaceuticals<\/strong>, the makers of the antidepressant\u00a0<strong>Effexor<\/strong>, issued a warning to U.S. and Canadian doctors that use of this drug could cause\u00a0<strong>hostility<\/strong>,\u00a0<strong>suicidal ideation<\/strong>\u00a0 and\u00a0 <strong>self-harm<\/strong> in patients under the age of 18. (Source: Wyeth Pharmaceuticals, \u201cDear Health Care Professional\u2026\u201d Health Canada, Health Products and Food Branch, August 22, 2003.)<\/p>\n<p style=\"text-align: left;\"><strong><u>United States, May 2007:<\/u><\/strong><strong>\u00a0<\/strong>\u00a0The FDA\u2019s MedWatch system published a warning on the\u00a0 <strong>psychostimulant\u00a0 Desoxyn<\/strong> which is used for ADHD stating that the drug could cause: <strong>sudden death<\/strong> with pre-existing structural cardiac abnormalities or other serious heart problems, psychiatric adverse events including\u00a0<strong>aggression <\/strong>and the\u00a0<strong>emergence of new psychotic or manic symptoms<\/strong>, <strong>long-term suppression of growth, seizures, visual disturbance, as well as serious cardiovascular adverse events<\/strong>. (Source: Food and Drug Administration (FDA), \u201cDetailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)\u201d, MedWatch, May 2007.)<\/p>\n<p style=\"text-align: left;\">_________________________________<\/p>\n<p style=\"text-align: left;\"><em>Dr Kohls is a retired physician\u00a0who practiced holistic mental health care for the last decade of his career. He writes a weekly column for\u00a0the Reader Weekly, an alternative newsweekly published in Duluth, Minnesota, USA. Many of Dr Kohls\u2019 columns are archived at <\/em><em><a target=\"_blank\" href=\"http:\/\/duluthreader.com\/articles\/categories\/200_Duty_to_Warn\" >http:\/\/duluthreader.com\/articles\/categories\/200_Duty_to_Warn<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Over the years, I have formally taught my patients (as well as many participants in my lectures and seminars) about the un-advertised dangers of psychiatric medications &#8211; especially the long-term brain alterations and drug-dependencies that drug companies don\u2019t test for before the FDA grants them marketing approval.  <\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[52],"tags":[],"class_list":["post-62413","post","type-post","status-publish","format-standard","hentry","category-health"],"_links":{"self":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/posts\/62413","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/comments?post=62413"}],"version-history":[{"count":0,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/posts\/62413\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/media?parent=62413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/categories?post=62413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/tags?post=62413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}