Posts Tagged ‘aggression’

Prozac is now a defense for murder, writes Australian Member of Parliament Martin Whitely

Wednesday, December 21st, 2011

For the first time in criminal history, a murder was attributed to an anti-depressant drug. (Photo Credit -The Daily Telegraph)

Perth Now – December 21, 2011

FIRST it was ADHD drugs, then organ donation, now WA Labor MP Martin Whitely is hoping to get some action on the fatal risks of antidepressant drugs, such as Prozac, to children.

Anti-depressant manufacturers warn that products such as Prozac should not be given to children, because of the potentially tragic consequences, but they are prescribed every day to Australian kids.

Some anti-depressants, prescribed to help lift people out of a depressive state, actually have the opposite effect and make things worse.

This is what happened, with fatal results, in the case of a 16-year-old boy in Canada who stabbed a friend to death.

For the first time in criminal history, a murder was attributed to an anti-depressant drug.

In the finding, handed down on the 16th of September 2011, a Canadian Judge said a 16-year-old boy, who stabbed his brother’s friend in the stomach, would not have committed the offence had he not been treated with the drug Prozac (a brand of Fluoxetine).

The judge accepted the evidence of psychiatrist, Dr Peter Breggin, who told the court the boy’s symptoms were consistent with a Prozac-Induced Mood Disorder with Manic Features.

In delivering his decision the judge stated, “his basic normalcy now further confirms he no longer poses a risk of violence to anyone and that his mental deterioration and resulting violence would not have taken place without exposure to Prozac”.

The boy, who had no history of violence, had been taking Prozac for three months, during which his parents observed a marked deterioration in his behaviour and mood, which included acts of violence and self-harm where previously no such signs existed.

His alarmed parents returned to his doctor for advice, but instead of taking him off Prozac or reducing his dosage, his doctor increased the dose, obviously believing more of what appeared to be causing these dangerous behaviours, would solve the problem.

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and is approved for use in Australia for the treatment of depression, obsessive compulsive disorder and premenstrual dysphoric disorder.

However, it is routinely prescribed ‘off label’ for a range of other conditions including panic and eating disorders.

Australian Government Department of Health and Ageing figures revealed that in the 2008 financial year, 110,848 Australians received Fluoxetine scripts that were subsidised via the Pharmaceutical Benefits Scheme.

Concerns about possible aggression and manic side effects of Prozac were first raised in Australia in the New South Wales parliament in 1995, just five years after the release of the drug in Australia.

Since 2007, the US Food and Drug Administration has labelled SSRI antidepressants including Prozac with the highest possible ‘black box’ warning stating:

“All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric.”

The US Black Box warning was followed by similar warnings in Australia. The evidence that led to these warnings came from, ‘pooled analyses of short-term placebo-controlled trials of anti-depressant drugs (SSRIs and others)’ which ‘showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents [by 100%], and young adults ages 18-24 (by 50 per cent) with major depressive disorder (MDD) and other psychiatric disorders.’ The fact that SSRI antidepressants like Prozac are supposed to manage severe depression in young people but increase the risk of suicidality poses obvious questions.

Over a 10 year period, up until 30 June 2011, more than 40 adverse events of self-harm and violence, including suicides, homicides and suicidal or homicidal ideation, for Fluoxetine were reported to the Australian Therapeutic Drugs Administration (examples are listed below).

Hundreds of reports were recorded by the TGA for other antidepressants however, it is impossible to know the true number of actual events, as the voluntary nature of the reporting system means only a fraction of actual incidents gets reported.

Despite the fact that the manufacturers advise that Prozac and other SSRI antidepressants are ‘not recommended for use in children and adolescents under 18 years of age’ they are frequently prescribed ‘off label’ to even very young children.

Data provided by the Commonwealth Department of Health revealed that in the 2007-8 financial year 3,752 Australian children 15-years-old or younger (863 were 10 or younger, 117 were six or younger) were prescribed Pharmaceutical Benefits Scheme-funded Fluoxetine.

Furthermore all the expense and risks of adverse side effects may be for little or no benefit. The efficacy of antidepressants are being questioned – with some high profile, mainstream critics, arguing that placebos are just as effective and much safer in treating moderate depression.

One such critic, Marcia Angell, MD, Senior Lecturer on Social Medicine at Harvard Medical School and former Editor-in-Chief of The New England Journal of Medicine, contends; ‘that clinical trials have failed to find antidepressants effective at all in mild to moderate depression; that many psychiatric drugs have devastating adverse effects, especially in children and when used long-term; and that despite the risks and uncertain benefits, use of psychiatric drugs is soaring and the heavy reliance on drugs diverts resources better spent on improving treatment’.

In summary, taxpayers are subsidising the ‘off label’ use by children and adolescents of antidepressants, with questionable efficacy, that double their risk of suicidality. This invites some obvious questions: Is this the best way to spend our taxes? And more importantly, is this the best way to help troubled young people?

* A sample from the Adverse Drug Reactions Committee (ADRAC) adverse event reports for Fluoxetine Hydrochloride:

  • A 54 year old woman attempted suicide. She was also suffering from mania and a confusional state.
  • A 36 year old woman “attempted suicide”.
  • A 36 year old woman was admitted to intensive care in a coma following a suicide attempt.
  • A 51 year old woman “had sudden urge to murder someone”.
  • A 37 year old woman was admitted to a psychiatric hospital suffering from “suicidal ideation, nausea, trembling, feelings of despair, anxiety, paranoia and fear”.
  • A 16 year old boy suffering from agitation and auditory hallucinations heard voices “telling him to kill his mother, father, sister and himself”.
  • A 45 year old man “became obsessively suicidal and cut his throat” 3/7 days after Prozac was stopped.
  • A 17 year old girl “became manic half an hour after commencing antidepressant.”
  • A 40 year old patient “experienced trembling, cramps, heard voices and had suicidal ideation.”
  • A patient of unrecorded gender and age experienced “homicidal and suicidal ideation.”
  • A patient of unrecorded gender and age attempted suicide after experiencing suicidal ideation.
  • A 44 year old patient “experienced akathisia, suicidal ideation and suicide attempt.”
  • A patient of unrecorded gender and age experienced “suicidal violence” and “aggression.”
  • A patient of unrecorded gender and age experienced “suicidal ideation.”
  • A patient of unrecorded gender and age experienced “suicidal ideation and “suicide attempt.”
  • A 50 year old patient experienced “suicidal ideation, suicide attempt and akathisia.”
  • A 37 year old patient attempted suicide.
  • A patient of unrecorded gender and age experienced “suicidal ideation and suicide attempt.”
  • A patient of unrecorded gender and age made a suicide attempt and was violent.
  • A 16 year old girl “attempted to hang herself with television cord from curtain rail in hospital bedroom. Nurse said she found her at the last moment.”
  • A 16year old girl “ingested 40 Panadol tablets. Also frequent self-harming.”
  • A 16 year old girl “attempted suicide by ingestion of 80 Panadol, 20 Panadeine, 7 Olanzapine.”
  • A 29 year old patient “developed acute suicidal akathisia” and made a suicide attempt.
  • A 73 year old patient “experienced homicidal ideation and made a suicide attempt.”
  • A 60 year old woman “experienced suicidal ideation, suicide attempt and homicidal ideation – she attempted to kill her parents.”
  • A 69 year old patient “experienced suicidal ideation and was very anxious.”
  • A 16 year old girl attempted to “strangle herself with and IPod cord in the bathroom of the hospital. Agitation. She ran around crying and banging her fists of the walls and windows begging to be let out. … it lasted about 10 minutes before I could settle her.”
  • A patient of unrecorded gender and age “took a fistful of sleeping pills.”
  • A 35 year old patient “murdered his wife whilst on Prozac. He had also experienced suicidal thoughts.”
  • A female patient of unrecorded age “became seriously depressed, complained of headaches, and clenching jaw, was unable to sleep and started to self-harm. She began to have suicidal thoughts, was hyperventilating, agoraphobic, had five suicide attempts, was confused, tearful, phobic, aggressive, experienced akathisia and suspected serotonin syndrome. She experienced weird dreams, was impulsive, light headed, had numbness and tingling limbs and committed suicide by hanging on 11 September 2000 on the second attempt.”
  • A 50 year old woman “became more depressed whilst taking Prozac. She wanted to throw herself off a train or bus, had difficulty sleeping, was pacing and restless, had voice hallucinations, would look in the mirror and see a different person, had murderous thoughts, stiff legs, was hot a lot, felt she was in a delirium, could not concentrate, was angry, had numbness in her hands and pins and needles a lot in her body.”
  • A 19 year old male “had thoughts about killing himself which made him violent, tried to hit someone else, tried to hit a security guard with feelings of killing and tried to do physical damage. Tried to hurt himself and had thoughts of hurting other people. He was walking faster than normal. Experienced aggression, insomnia and was feeling high on Prozac. Also felt anxious and put on more than 20kg.”
  • A male of unreported age “experienced severe depression, cognitive impairment and was acutely suicidal.”
  • A 16 year old girl was “cutting herself, throwing herself against the walls while an inpatient”. She “intentionally overdosed on Fluroxetine” and “developed severe levels of aggression and violence.”
  • A 14 year old boy experienced “suicidal ideation.”
  • A female of unreported age “experienced suicidal ideation”.
  • A 16 year old girl experienced “excessive bleeding, psychosis, high blood pressure, severe diarrhea, sweating, tremors, violent, aggressive and suicidal behavior, serotonin syndrome.”
  • A 14 year old male experienced “severely increased suicidal ideation in two days with high level of intent and plan to jump in front of train. Previously no suicidal ideation and settled spontaneously within four days of ceasing Fluoxetine”.
  • A female patient experienced a “sudden and marked increase in hostility and verbal abuse of others and describes intrusive suicidal ideation. Seems agitated and restless”.
  • A 32 year old woman experienced “audio hallucinations, bright and blurred vision, made everything sound louder, constipation, increased suicidal thoughts and increased anxiety”

http://www.perthnow.com.au/news/western-australia/prozac-is-now-a-defence-for-murder/story-e6frg13u-1226227796937

Note from CCHR International:  CCHR is the only organization to have decrypted the US FDAs Medwatch reports on adverse reactions to psychiatric drugs and compiled them in an easy to search database.    This database is provided here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

CCHR has also compiled all international drug warnings and studies on psychiatric drugs here http://www.cchrint.org/psychdrugdangers/drug_warnings.php

 

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Can Prozac Cause Kids to Kill? A Canadian Judge Has Ruled it Can

Wednesday, December 7th, 2011

Note from CCHR:

(see videos at the bottom of this post from film maker Michael Moore and Fox National News reporter Douglas Kennedy)

It is well documented that psychiatric drugs, particularly antidepressants, can cause a host of violent side effects including mania, psychosis, aggression, violence and in the case of the antidepressant Effexor, homicidal ideation.   As far back as 1991, CCHR helped organize dozens of individuals and experts testifying before the US FDA that people with no prior history of violence (or suicide) became homicidal and suicidal under the influence of antidepressants (see CCHR’s exclusive footage of the 1991 hearings here).  It would take the FDA another 13 years to admit antidepressants could cause suicide and black box warnings were finally issued in 2004.  However, despite all the documented violence-inducing side effects of these drugs, the FDA has never issued black box warnings on antidepressants causing violence or homicide despite the fact that at least 11 recent school shootings were committed by kids documented to be on or in withdrawal from psychiatric drugs (see Fox News special report on school shootings here).   Therefore, the case cited below, where a Canadian judge ruled that a teenage boy murdered his friend due to being on the antidepressant Prozac, and the fact that the case will not be appealed, is a major turning point in exposing the violence inducing effects of antidepressant drugs.  

National Post
By Tom Blackwell
December 7, 2011

JB Reed/Bloomberg News

A Winnipeg judge’s ruling that a teenage boy murdered his friend because of the effects of Prozac will not be appealed, confirming an apparent North American first and reviving debate around the widespread prescription of anti-depressants to young people.

Justice Robert Heinrichs concluded the 15-year-old boy was under the influence of the medication when he thrust a nine-inch kitchen knife into the chest of Seth Ottenbreit, a close friend.

Although the killer pleaded guilty to second-degree murder, the judge cited the drug’s alleged side effects as a reason not to raise the case to adult court, and to mete out a sentence last month of just 10 months – on top of two years already spent in jail.

A spokeswoman for the Manitoba Justice Department said this week prosecutors have decided not to appeal the provincial-court decisions, which were earlier met with outrage from Mr. Ottenbreit’s family and friends.

Both the boy’s lawyer and the psychiatrist who testified on his behalf say it is the first time a criminal-court judge in North America has made such a finding.

Prozac is meant to curb the effects of depression, but Justice Heinrich concluded it set off a steady deterioration in the young murderer’s behaviour.

“He had become irritable, restless, agitated, aggressive and unclear in his thinking,” the judge said. “It was while in that state he overreacted in an impulsive, explosive and violent way. Now that his body and mind are free and clear of any effects of Prozac, he is simply not the same youth in behaviour or character.”

Yet the empirical underpinning of his conclusion, and the pros and cons of young people taking Prozac and other “selective serotonin reuptake inhibitor (SSRI)” anti-depressants, seem less clear-cut.

Justice Heinrichs relied largely on the expert testimony of Dr. Peter Breggin, a controversial American physician known for his outspoken opposition to the use of virtually any psychiatric drug. Some other experts say scientific evidence of a link between the latest anti-depressants and homicide is thin.

“I think it got pulled out of a hat, frankly,” said Dr. Umesh Jain, a child and adolescent psychiatrist at Toronto’s Centre for Addiction and Mental health. “You could construct a weak and biologically plausible effect, but you’d have to be pretty convincing in court.”

Studies have established such drugs can increase the risk of young patients having suicidal thoughts. Their tendency to lift inhibition could also release some hostility or violence lurking in a person’s character, said Dr. Jain. Small studies like one he co-authored in 1992 have also suggested that the drugs can trigger short-term mania, especially in bi-polar disorder patients.

There is little or no scientific evidence directly linking the anti-depressants and serious violence or homicide, though, he said.

Still, the official “product monograph” approved by Health Canada for Prozac says the drugs are not recommended for use on adolescents, and warns that agitation, hostility and aggression might ensue. Doctors are allowed to prescribe medications “off label” to patients even when the approval does not expressly permit it.

Specialists in Winnipeg responded to concerns voiced by the accused’s parents by actually increasing the dose, said Greg Brodsky, the teenager’s lawyer.

“On Prozac he was becoming more irrational and aggressive,” Mr. Brodsky said. “That should have been a warning. That warning wasn’t heeded.”

SSRI drugs have a contentious track record. They were hailed originally as a safe alternative to older anti-depressants, then clinical-trial results came to light in 2004 that suggested they increased the risk of children and adolescents having suicidal thoughts.

Other studies have indicated they are effective in patients with major depression, but little better than a placebo for mild to moderate cases.

The Winnipeg murderer had a history of smoking marijuana, had abused prescription drugs and “experimented” with cocaine, but was trying to break free of that background when a family doctor prescribed Prozac for depression in July, 2009.

On Sept. 20, the accused met with Mr. Ottenbreit and another friend at his house, after the two friends had earlier stormed into his home, allegedly damaging the floor. The killer and Mr. Ottenbreit shared a cigarette, before the accused pulled aside a sweater on the floor of his garage, revealing the knife. He picked it up, “got this weird look on his face,” then abruptly stabbed his friend, the other boy told police.

“They were in my house, they dented the floor, I had nothing else to do but to stab him,” he told police later.

Dr. Keith Hildahl, clinical head of Winnipeg’s Child and Adolescent Mental Health program, testified that the Prozac might have played a role, but concluded on balance that his behaviour that summer was largely a result of the tense relationship he had with his parents.

Dr. Breggin, who has testified in a number of U.S. cases where anti-depressants allegedly led to murder or other violence and reviewed the Winnipeg case, pointed the finger of blame at the medication.

“These drugs produce a stimulant or activation continuum,” he said in an interview. “That continuum includes aggression, hostility, loss of impulse control … all of which are a prescription for violence.”

Dr. Breggin’s long-standing criticism of psychiatric drugs and opposition to the view that psychiatric problems have biochemical roots have prompted some supporters to call him the “conscience” of the speciality, and some psychiatrists and patient advocates to condemn him as a harmful influence.

Read article here:  http://news.nationalpost.com/2011/12/07/prozac-defence-stands-in-manitoba-teens-murder-case/

See Michael Moore discuss the need for an investigation into psychiatric drugs causing violence:

See Fox National News on School Shootings and Psychiatric Drugs:

To read international warnings and studies on psychiatric drugs causing violence – visit CCHRInt’s Psychiatric Drug database and simply type in keywords such as violence, mania, psychosis, aggression in the red search box

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PEOPLE’S PHARMACY:Can drugs cause violent behavior?

Thursday, July 21st, 2011

Tuscaloosa News – July 21, 2011

PEOPLE’S PHARMACY

Americans revere personal responsibility. It resonates with our respect for accountability and frontier justice. That may explain why we have a hard time believing that medications could alter people’s personalities or lead them to behave badly.

Violence as a drug side effect seems preposterous to patients, pharmacists, physicians and even juries. Trying to use the “Prozac defense” to justify killing or hurting someone is often met with scorn.

Although drug-induced hostility or aggression has not been well-studied, a surprising number of medications come with precautions about violent acts.

Antidepressant prescribing information, for example, warns physicians that, “All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior.” Drugs such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil) and sertraline (Zoloft) carry warnings about aggressiveness, agitation, hostility, impulsivity and irritability.

The stop-smoking medication varenicline (Chantix) also comes with warnings about agitation, hostility, depressed mood and changes in behavior. The trouble with such warnings is that people don’t imagine that these bad things could happen to them. But many readers have shared scary stories about Chantix and violence. Here is one:

“I started taking Chantix early in January 2011 because I promised my son I’d quit. After about two weeks on the drug, my husband and I got into a disagreement, and I ended up giving him a black eye and busting out his tooth. Rage and panic attacks were occurring every day, so I quit taking Chantix.

“I figured it was just the stress of having to live with my in-laws, so I stayed off it until I left my husband and got my own place with my son. I’ve now been taking Chantix for about two weeks, and I’m having emotional outbursts and extreme rage again. I have no stress in my life right now, so it can’t be anything else but the drug.

“I’ve researched this, and apparently Chantix is at the top of a list of drugs that cause violent behavior. Chantix worked very well for a friend of mine to help her stop smoking, but now I wonder if it contributed to her breakup with her fiance.”

Other readers have shared stories of people who had no history of aggressiveness, violence or mental-health problems going berserk while taking Chantix. One man beat his wife and called police but had no recollection of the incident.

A recent article in the European Journal of Clinical Pharmacology (online, June 7, 2011) “confirms the risk of violence associated with benzodiazepines and related drugs (zopiclone and zolpidem). … Physical aggressiveness, rapes, impulsive decision making and violence have been reported, as have autoaggressiveness and suicide.”

Benzodiazepines are anti-anxiety agents such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium) and lorazepam (Ativan). Eszopiclone and zolpidem are popular prescription sleep aids. Americans need to know how prescribed drugs might affect their behavior. Only then can they take responsibility for their actions.

http://www.tuscaloosanews.com/article/20110721/NEWS/110719697/1005/sitemaps04?p=2&tc=pg

(Note from CCHR:  Our psychiatric drug database, comprised of international drug regulatory agency warnings and clinical studies,  contains 19 warnings of psychiatric drugs causing violence, aggression and hostility -  type in aggression in the red search box – or suicide which has 66 warnings)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php )

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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New Jersey – Drinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

Oklahoma – Kaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Psychiatric News — Antidepressants/Antismoking Drugs Linked to Violent Behavior

Friday, February 4th, 2011

Psychiatric News February 4, 2011
Volume 46 Number 3 Page 16

by Joan Arehart-Treichel

A psychiatrist with a particular interest in violence believes that psychiatrists should become aware that the antismoking medication varenicline and antidepressants have been linked with violent behavior.

The association was made by Thomas Moore, Joseph Glenmullen, M.D., and Curt Furberg, M.D., Ph.D. Moore is a senior scientist for drug safety and policy at the Institute for Safe Medication Practices (ISMP) in Horsham, Pa. The ISMP is a nonprofit organization that educates health care providers and the public about safe medication practices. Glenmullen is a clinical instructor of psychiatry at Harvard Medical School, and Furberg is a professor of public health sciences at Wake Forest University.

In a study published in the December 15, 2010, PloS One, the researchers used 2004 to 2009 data from the Food and Drug Administration (FDA) Adverse Event Reporting System. They found that during the study period, 780,169 serious adverse events of one kind or another had been reported for 484 drugs, and that of those serious adverse events, 1,937 had been acts of violence. They defined a violent event as any case report containing one or more of the following items: homicide, physical assault, physical abuse, homicidal ideation, or violence-related symptom, but not more ambiguous descriptions such as crime, aggression, belligerence, or hostility.

The researchers then set out to see whether any of the 484 drugs had been disproportionally linked with the acts of violence. To be “disproportionally linked,” a drug had to be associated with at least five cases of violence, to have at least twice as many cases of violence associated with it as expected given the volume of overall adverse events reported for it, and statistical analysis had to indicate that the violence cases associated with it were unlikely to have occurred by chance.

The researchers found that 324 of the 484 drugs (67 percent) had no link with violence cases and that 86 of the drugs (18 percent) had links with only one or two cases of violence. However, 31 of the drugs (6 percent) were found to be disproportionally linked with violence cases. These drugs included varenicline, 11 antidepressants, three drugs for attention-deficit/hyperactivity disorder, and five hypnotics/sedatives.

Moreover, of the 484 drugs evaluated, varenicline had the largest number of violence cases, the highest proportion of violence cases (PRR = 18.0), and the highest statistical probability that the violence cases associated with it were not by chance (x2 = 5,172df = p<0.01).

Thus “varenicline had the strongest association with violence by every measure used in this study,” Moore and his colleagues pointed out. “In addition, antidepressant drugs showed consistently elevated risk, even when compared with antipsychotics and mood stabilizers. . . .”

Just because these drugs have been linked with cases of violent behavior does not prove that they actually promoted such behavior. Yet some of the varenicline-linked violence cases that Moore and his colleagues scrutinized suggested to them that there might be a causal connection. For example, the individuals in question started displaying psychiatric symptoms a few days after they had begun taking varenicline. They appeared to direct their violence senselessly, that is, at anybody who happened to be near them, and once they stopped taking varenicline, they stopped engaging in violent acts.

As Moore told Psychiatric News, both an earlier study his research group conducted and one by FDA researchers “noted that the onset of adverse effects for varenicline frequently occurs before the subject stops smoking,” implying that it is varenicline, not nicotine withdrawal, that prompts violent behavior. Still another reason to believe that it is the medication, not nicotine withdrawal, that leads to violent behavior is that “varenicline has a seven-day dose-escalation period prior to setting a target date to stop smoking,” Moore noted.

This study is “a preliminary review of adverse events . . . that indicate a risk of violence toward others,” Darrel Regier, M.D., M.P.H., director of APA’s Division of Research and executive director of the American Psychiatric Institute for Research and Education, told Psychiatric News. “[Also the findings come] from a historically difficult database to interpret—FDA adverse event data. . . . There is clearly a need to conduct prospective studies [to see whether the findings can] be confirmed. The same was true for the proported risk of suicidality associated with antidepressants.”

“This seems to be a reasonably good study with a high number [of medications evaluated] and a lot of double-checking,” Paul Fink, M.D., an expert in the study of violent behavior and a past APA president, commented. “I can tell you that as a psychiatrist who has practiced for a long time, I was unaware that [varenicline and antidepressants] had been linked with violence toward others. . . . Psychiatrists and mental health professionals need to be aware of this association.”

The study had no outside funding.

http://pn.psychiatryonline.org/content/46/3/16.1.full

“Prescription Drugs Associated With Reports of Violence Toward Others” is posted at <www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015337>. Graphic

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Hundreds of U.S. Pilots Treated for Drug Abuse and Psychiatric Disorders, Review Finds

Wednesday, September 15th, 2010

Note From CCHR: If the fact that commercial airline pilots are now allowed to fly while under the influence on antidepressants and antipsychotic drugs doesn’t send off any alarm bells, then perhaps you should take two minutes and try this— go to this link http://www.cchrint.org/psychdrugdangers/drug_warnings.php and in the Search box (with the red text) simply type in the word suicide and scroll down the page to quickly look over the results.   Then search  aggression,  hallucinations, violence and psychosis.   By reversing their previous ruling and now allowing commercial airline pilots to fly under the influence of these drugs, the FAA is playing a game of Russian Roulette with all of us.

FoxNews.com

Published September 15, 2010

By Jessica Heslam

Boston Herald

Hundreds of commercial and private U.S. pilots have been diagnosed and treated for a broad array of serious psychiatric and medical conditions, including schizophrenia, attempted suicide, sexual deviance, alcoholism and drug abuse, a Herald review has found.

The review comes in the wake of a chilling episode at Logan International Airport four months ago involving a distraught JetBlue [JBLU] pilot who threatened to “harm himself in spectacular fashion” an hour before takeoff – an incident that sent shudders through airline passengers across the country.

Medical record data from 2008, 2009 and 2010 provided by the Federal Aviation Administration under a public records request show:

– 15 pilots – including one from Massachusetts – have been treated for or diagnosed with schizophrenia.

– Another 292 pilots have attempted suicide, including five Bay Staters.

– 2,700 pilots have been treated for alcohol abuse, including 34 from Massachusetts, and another 1,253 have been diagnosed as alcoholics – including 20 Bay Staters.

– 1,377 pilots have been treated for drug abuse – 23 from Massachusetts – and another 94 for drug dependence.

Read the rest of this article here:  http://www.foxnews.com/us/2010/09/15/hundreds-pilots-treated-drug-abuse-psychiatric-disorders-review-finds/?test=latestnews

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Chantix & Violence: What Patients Have In Common

Thursday, July 22nd, 2010

Pharmalot
By Ed Silverman
July 22, 2010

For the past three years, the Chantix smoking cessation pill has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med (see this). The FDA subsequently imposed a risk management program and Pfizer added warnings.

Now, a new study in The Annals of Pharmacotherapy finds Chantix is not only associated with violent and agressive thoughts and acts, but has also identified some of the common characteristics among people using the pill and their subsequent behavior. The drug “does have warnings about psychiatric side effects, but it skims over aggression/violence towards others to focus mainly on suicidal behaviors,” says Thomas Moore, one of the co-authors and a senior scientist at the Institute for Safe Medication Practices, a non-profit that has issued reports previously about Chantix side effects.

“We believe this may be the first scientific report to examine the characteristics of aggression/violence as a psychiatric side effect for any prescription drug. What do these cases look like? A question answered for possibly the first time. We found the details striking and chilling. This is the first time we know of that aggression/violence has been clearly documented as a side effect in a peer reviewed scientific journal. This raises the question of whether (Chantix) is suitable for use in the military, by police and others who are already in stress situations. One key characteristic of these events is uncontrollable rage. Not a good side effect for people paid to carry guns.”

The researchers obtained 78 adverse event reports from the FDA MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; four more cases came from clinical trials, and three others came from published literature. Ultimately, they used 26 case reports for study and these described 10 events with assault, nine cases of homicidal ideation and seven instances of other thoughts or acts of aggression/violence. They noted that the patient population was predominantly middle-aged women, but “an unlikely age group and sex for assault and acts of violence toward others.”

“In all 26 cases,” they write, “the acts or thoughts of violence appeared to be inexplicable and unprovoked. A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car, with a young granddaughter also present. A 42-year-old man punched a stranger at a bowling alley. The stranger and two friends responded and knocked out the subject’s front teeth. A 24-year-old female started beating her boyfriend in bed because he “looked so peaceful” and she later attempted suicide. A 29-year-old female struck an acquaintance twice in the face, and then started smashing doors in her own home and beating on her truck.”

Read entire article:  http://www.pharmalot.com/2010/07/chantix-and-violence-what-patients-have-in-common/

*The package insert for Chantix shows that it contains a type of chemical compound that is better known as benzodiazepine—benzodiazepines are otherwise known as anti-anxiety drugs.

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The Huffington Post: “Pilots Taking Antidepressants? The FAA Is Risking Our Lives”

Monday, April 19th, 2010

The Huffington Post
By Peter Breggin
April 19, 2010

A few years ago I was hired by the FAA to defend the agency against a suit brought by a pilot who wanted to fly while taking a prescription antidepressant. I helped the FAA formulate its defense of the agency’s ban on pilots using antidepressants and, as a result, the ban remained in effect. Pilots remained unable to fly while taking antidepressants, including the newer ones such as Prozac, Paxil, Zoloft, Celexa, Lexapro and Effexor.

How times have changed. Ignoring the scientific data on adverse drug effects that the agency and I generated and evaluated for the earlier case, the FAA is lifting its 70-year-old ban on allowing pilots to take antidepressants. Has the science changed–improving the adverse reaction profile of these drugs? To the contrary, since that time my most dire observations have been confirmed in the FDA-approved label for all antidepressants. Now there is not only a Black Box Warning for suicidality in children, youth and young adults, but also a lengthy Warnings section about a variety of extremely dangerous abnormal behavioral reactions in all ages including aggression, hostility, disinhibition, impulsivity and mania. Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence.

According to the FDA-approved guidelines, prescribers are supposed to give a special Medication Guide to patients and their families that warns about dangerous drug-induced reactions including suicide, violence and a variety of unexpected negative behaviors. Originally intended for children and youth, the Medication Guide is now expanded to cover all age groups, including adults. The Medication Guide for all ages can be found at the conclusion of each FDA-approved label for antidepressant drugs in the 2010 Physicians’ Desk Reference.

Why did the FAA lift the ban on pilots using antidepressants? According to FAA statements to the media, depressed pilots sometimes kept on flying while secretly taking antidepressants. “Our concern is that they haven’t necessarily been candid,” FAA Administrator Randy Babbitt reportedly told the press on a conference call. They were flying below the radar of drug testing, so to speak. The new policy not only allows pilots to use antidepressants, it grants a degree of amnesty to those who have been using them illegally in the past.

The FAA feels it’s safer to allow the use of antidepressants because it will make it easier for pilots to obtain needed treatment for depression. It supposedly will also make it easier to monitor their use of these dangerous drugs. If we accept this argument, why not legalize stimulants such as amphetamine as well? They would help keep the overworked pilots awake. And while the FAA is at it, why not let them use marijuana, since they may be doing it illegally on their own without anyone monitoring them.

Unfortunately, monitoring pilots on antidepressants won’t work nearly as well as might be hoped. Many severe emotional and behavioral reactions occur in the first one to three days of antidepressant dosing, or shortly after dose changes, either up or down–long before the next scheduled appointment. Although close monitoring and informing the family to be on the alert can be helpful, and should be done, it won’t prevent many of the drug reactions that occur abruptly and without warning. In addition, doctors too often fail to warn the patient and the family about the risks. As a medical expert, I’ve learned how cavalier some prescribers are in regard to warning patients about the adverse effects of any psychiatric drugs.

Read entire article:  http://www.huffingtonpost.com/dr-peter-breggin/antidepressants-pilots-ta_b_542240.html

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