Posts Tagged ‘Black Box Warnings’

ABC News: Doctors Put Foster Children at Risk With Mind-Altering Drugs

Thursday, December 1st, 2011

December 1, 2011
by BRINDA ADHIKARI, JOAN MARTELLI and SARAH KOCH
video platformvideo managementvideo solutionsvideo player

Across America, doctors are putting foster children on powerful, mind-altering drugs at rates up to 13 times that of children in the general population. What’s more, doctors are prescribing foster children drugs at doses beyond what the Food and Drug Administration has approved, sometimes in potentially dangerous combinations, according to a new report by the federal Government Accountability Office.

“It’s just almost beyond comprehension,” said Sen. Thomas Carper, D-Del., who asked for the GAO investigation. “We want the doctors and nurses that are prescribing these medicines to look at their behavior and think and ask this question. Are we doing something wrong here?”

In Florida, regulator Gabriel Myers, killed himself in 2009 after being prescribed a powerful mix of psychotropic medication.

In Florida, regulators have been grappling with that question since a 7-year-old boy, Gabriel Myers, killed himself in 2009 after being prescribed a powerful mix of psychotropic medication.

His psychiatrist, Dr. Sohail Punjwani, had, at different times, prescribed two drugs that carry black box labels — warning of the need to carefully monitor patients because of the increased risk of suicidal thoughts and behavior in children, which call for careful monitoring. However, even though Gabriel visited Punjwani’s office seven times, his foster father said Gabriel usually only spent about five minutes talking to the doctor.

Gabriel’s death was ruled an accident, but investigators pointed to the possibility that the medication may have contributed to his death. The tragedy triggered a storm of outrage across the state.

“I don’t accept that the only way to reach a child who is 7 years old is through psychotropic drugs,” said Florida Sen. Ronda Storm, during hearings over Gabriel’s death. “I do not accept that.”

The boy’s doctor settled a lawsuit in 2010 accusing him of prescribing a toxic cocktail of psychotropic drugs to a 16-year-old patient, who suffered a sudden heart attack and died. Punjwani settled that case but admitted no wrongdoing.

Additionally, Punjwani was arrested for driving under the influence and cocaine possession. He pleaded not guilty to those charges but went through a court-ordered rehabilitation program.

When ABC News caught up with Dr. Punjwani, he told us, “Sad stories happen but that does not mean that everything else the doctor is responsible for it because we are in the business of taking care of these children,” he said.

Antipsychotic medication, which can cause a litany of health problems such as severe weight gain, an increased risk of diabetes and irreversible movement disorders, is among the top-selling drugs in America.

Four drug makers have paid a total of more than $2 billion to settle claims they illegally marketed antipsychotics to children. All deny wrongdoing.

“How do antipsychotics, drugs supposedly for people who have lost touch with reality, how do they develop such a wide market?” said neuropsychiatrist Dr. Stefan Kruszewski, who won millions of dollars as a key whistleblower against drug companies.

There have been very limited long-term studies on antipsychotics in children. And for drugs already on the market, the duration of the studies that were used to get FDA approval for children have been as short as three to six weeks.

ABC News interviewed a social worker now working in a state foster care system, who asked not to be identified.

“Every child that I saw was basically on some type of psychotropic medication,” the social worker told ABC News. “It’s much easier to medicate a child than it is to physically restrain them, than it is to pay $200 an hour to a therapist to talk through their problems with them.”

Read the reset of the article here

Watch the year-long investigation tonight on “World News with Diane Sawyer” at 6:30 p.m. ET and then see more on “20/20,” Friday at 10 p.m. ET.

« Return to news items


Share

New Study Links ADHD Drugs, Antidepressants, Hypnotics & Anti-Smoking Drug to 1,527 Acts of Violence

Thursday, December 16th, 2010

Pharmalot, December 16, 2010

by Ed Silverman

For years, there were contentious debates about links between certain prescription meds, notably antidepressants, and suicidal behavior. Now, the focus is turning to violent behavior directed toward others. And a new study is linking 31 widely prescribed drugs – most notably, the Chantix anti-smoking pill – with 1,527 serious acts of violence, such as physical abuse, physical assault and homicide.

The study, which was published in PLoS One, identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds, including 1,937 cases meeting the violence criteria determined by the researchers. There were 387 reports of homicide, 404 physical assaults, 27 cases indicating physical abuse, 896 homicidal ideation reports and 223 cases described as violence-related symptoms.

Besides Pfizer’s Chantix, 11 antidepressants, three ADHD meds and five hypnotics or sedatives were linked to 79 percent of the violence cases. Looked at another way, no cases of violence were reported for 324 of the 484 drugs evaluated. And so an association with violence appeared “highly unlikely” for nearly 85 percent of all evaluated drugs in widespread clinical use.

This is not, by the way, the first time that Chantix has been linked to violent behavior. The same authors published a study last summer in The Annals of Pharmacotherapy that found Chantix is not only associated with violent and aggressive thoughts and acts, but they also identified some of the common characteristics among people using the pill and their subsequent behavior (see this).

“Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. (Chantix), which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs,” the researchers write. Interestingly, this finding appears just after the infamous Zoloft defense case drew to a close. That involved a 12-year-old boy who killed his grandparents and his lawyers blamed the antidepressant (read here).

The authors do, however, cite some limitations. The submission of an individual adverse event report does not itself establish causality,” the note, “only that a reporting individual suspected a relationship existed.” And they add that the quality and detail in each report varies. On the other hand, they also say that, “given that violent thoughts or actions are not typically attributed to drug therapy or recorded in medical records, the reporting rate for violence cases could be very low. The selected violence cases do not provide a reliable estimate of how often they might occur.”

In the end, they recommend prospective studies to “establish the incidence, confirm differences among drugs and identify additional common features.”

http://www.pharmalot.com/2010/12/chantix-prescription-drugs-and-violent-acts/

Note from CCHR:  As far back as 1991, the FDA held hearings into antidepressants causing suicidal ideation and violence, largely prompted by CCHR’s demands for an investigation. CCHR testified along with dozens of victims and medical experts.   The FDA panel, largely Pharma funded, refused to issue warnings despite the evidence presented. It would take the FDA another 13 years to finally admit antidepressants cause suicidal ideation and issue black  box warnings on the drugs.  The FDA has still never fully investigated the overwhelming evidence linking antidepressants and other psychiatric drugs to acts of violence and homicide.

Watch this video, produced by CCHR, of the 1991 FDA hearings into antidepressants causing suicide and violence http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/6/FxJomeak4V4

Also Watch This Fox National News Special Report’s from Douglas Kennedy Deadly Drugs - http://www.youtube.com/watch?v=9S-7aNPf33A

« Return to news items


Share

Americas Mental Illness Epidemic

Thursday, August 26th, 2010

Rense.com
By Gary G. Kohls, MD
August 25, 2010

Tens of millions of innocent, unsuspecting Americans, who are mired deeply in the mental “health” system, have actually been made crazy by the use of or the withdrawal from commonly-prescribed, brain-altering, brain-disabling, indeed brain-damaging psychiatric drugs that have been, for many decades, cavalierly handed out like candy ­ often in untested and therefore unapproved combinations of drugs – to trusting and unaware patients by equally unaware but well-intentioned physicians who have been under the mesmerizing influence of slick and obscenely profitable psychopharmaceutical drug companies aka, BigPharma.

That is the conclusion of two books by investigative journalist and health science writer Robert Whitaker. His first book, entitled Mad in America: Bad Science, Bad Medicine and the Enduring Mistreatment of the Mentally Ill noted that there has been a 600% increase (since Thorazine was introduced in the US in the mid-1950s) in the total and permanent disabilities of millions of psychiatric drug-takers. This uniquely First World mental ill health epidemic has resulted in the life-long taxpayer-supported disabilities of rapidly increasing numbers of psychiatric patients who are now unable to be happy, productive, taxpaying members of society. Whitaker has done a powerful, albeit unwelcome job of presenting previously hidden, but very convincing evidence to support his thesis, that it is the drugs and not the diagnosis that is causing the epidemic of mental illness disability. Many open-minded physicians and many aware psychiatric patients are now motivated to be wary of any and all synthetic chemicals that can cross the blood/brain barrier because all of them are capable of altering the brain in ways totally unknown to medical science, especially when the patients are taking the drugs long-term..

In Whitaker’s second book Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, he goes much further in advancing this sobering reality. He documents the history of the powerful forces behind the relatively new field of psychopharmacology and its major shaper and beneficiary, BigPharma. Psychiatric drugs, whose developers, marketers and salespersons are all in the employ of the giant drug companies, are far more dangerous than the drug and psychiatric industries are willing to admit: These drugs, it turns our, are fully capable of disabling ­ often permanently – body, brain and spirit.

More evidence to support Whitaker’s well-documented claims are laid out in two important new books written by psychiatrist and scholar Grace Jackson. Jackson did a beautiful job of researching and documenting, from the voluminous basic neuroscience research (which is uniformly ignored by the clinical sciences) the unintended and often disastrous consequences of the chronic ingestion of any of the five major classes of psychiatric drugs. Her second and most powerful book: Drug-Induced Dementia: A Perfect Crime, proves beyond a shadow of a doubt, that any of the five classes of drugs that are commonly used in psychiatric patients (antidepressants, antipsychotics, psychostimulants, tranquilizers and anti-seizure/”mood-stabilizer” drugs) have shown microscopic, macroscopic, biochemical, clinical and/or radiological evidence of brain shrinkage and other signs of brain damage, which can result in clinically-diagnosable, permanent dementia, premature death and a variety of other related brain disorders that can mimic mental illnesses. Jackson’s first book, Rethinking Psychiatric Drugs: A Guide for Informed Consent was an equally sobering book warning about the many hidden dangers of psychiatric drugs.

This sad truth is that the seemingly knee-jerk prescribing (without very much information being given to patients about the long list of serious long-term adverse effects) of potent and often addicting/dependency-inducing psychiatric drugs has become the standard of care in American psychiatry since the introduction of the so-called anti-schizophrenic “miracle” drug Thorazine in the mid-1950s. (Thorazine was the offending drug that all of Jack Nicholson’s fellow patients were coerced into taking at “medication time” in the Academy Award-winning movie “One Flew Over the Cuckoo’s Nest”.) Thorazine and all the other “me-too” early antipsychotic drugs are now universally known to have been an iatrogenic (= doctor or other treatment-caused) disaster because of their serious long-term, initially unsuspected, brain-damaging effects that resulted in a number of incurable neurological disorders such as tardive dyskinesia and Parkinson’s disease.

Thorazine and all the other knock-off drugs like Prolixin, Mellaril, Navane. etc, are synthetic “tricyclic” chemical compounds similar in molecular structure to the tricyclic “antidepressants” like imipramine and the similarly toxic, obesity-inducing, diabetogenic, “atypical” anti-schizophrenic drugs like Clozaril, Zyprexa and Seroquel.

Thorazine, incidentally, was originally developed in Europe as an industrial dye. That doesn’t sound so good although it may not be so unusual in the closely related fields of psychopharmcology and the chemical industry, especially when one considers that Depakote, a popular drug marketed initially as an anti-epilepsy drug but now is being heavily used as a so-called “mood stabilizer”. Depakote, known to be a hepatotoxin and renal toxin, was originally developed as an industrial solvent capable of dissolving fat – including, presumably, the fatty tissue in human livers and brains.

Some sympathy and understanding needs to be generated for the various victims of BigPharma’s compulsive drive to expand market share and “shareholder value” (share price, dividends and the next quarter’s financial report) by whatever means necessary. Both the prescribers and the swallowers of BigPharma’s drugs have succumbed to BigPharma’s cunning marketing campaigns, the prescribers having been seduced by attractive drug company representatives and their “pens, pizzas and post-it note” freebies in the office, and the patients being brain-washed by the inane and unbelievable (if one has intact critical thinking skills) commercials on TV that quickly gloss over the lethal adverse effects in the fine print while urging the watcher to “ask your doctor” about the latest unaffordable wannabe blockbuster drug..

For a quick overview of these issues, I recommend that everybody with an open mind read a long essay written by Whitaker that persuasively identifies the source of America’s epidemic of mental illness disability (a phenomenon that doesn’t exist in Third World nations because costly psych drugs are not prescribed so cavalierly as in the US).

Whitaker and Jackson (among a number of other ground-breaking and whistle-blowing authors who have been essentially black-listed by the mainstream media and mainstream medical journals) have proven to most critically-thinking scientists, alternative practitioners and assorted “psychiatric survivors” that it is the drugs – and not the so-called “disorders” – that are causing our nation’s epidemic of mental illness disability. The Whitaker essay, plus other pertinent information about his books can be accessed at www.madinamerica.com A recent interview on Wisconsin Public Radio can be accessed at www.wpr.org (at their radio archives link) and a long interview with Dr.Joseph Mercola can be heard at: http://articles.mercola.com/sites/articles/archive/2010/05/08/robert-whitaker-interview.aspx

After reading and studying all these inconvenient truths, mental health practitioners must consider the medicolegal implications for them, especially if the information is ignored or if the information is dismissed out of hand by practitioners who might be tempted to not take the time to study this new information. Those people who are hearing about this for the first time need to pass the word on to others, especially their prescribing healthcare practitioners who should be equally concerned. This is important because the opinion leaders in the highly influential (for good or ill) psychiatric and medical industries have been marketed into submission without hearing the all the facts (which may have been intentionally hidden from them. If that is the case, they cannot be automatically blamed for proceeding in a practice that some day might represent malpractice. It shouldn’t have to be pointed out that is the solemn duty of ethical practitioners who are in positions of authority to fully examine potential malpractice issues and then warn others, especially their patients, of the dangers.

Sadly, it must be admitted that most of the over-worked, double-booked care-givers in medical clinics have not yet heard the news that most if not all of the brain-altering synthetic chemicals known as psychotropic drugs (which are treated as hazardous waste unless they are packaged in a swallowable capsule!) have been marketed as safe and effective – but only for short-term use. The captains of the drug industry know that the psychotropic drugs that they present for the FDA-approval have only been tested in animal trials for days and in clinical trials for 6 weeks. They also know ­ indeed they hope – that patients will be taking their drugs for years (despite no long-term trials proving safety and efficacy) as the only “treatment” for mental ill health. They know that their brain-altering drugs are also dependency-inducing (aka addicting, causing withdrawal symptoms when stopped), neurotoxic and increasingly ineffective (a la “Prozac Poop-out”) as time goes by.

The truth is that the people diagnosed as “mentally ill” for life are often simply those unfortunates who find themselves in acute or chronic states of crisis or “overwhelm” due to any number of preventable, curable and treatable (without the use of drugs) bad luck accidents such as poverty, abuse, violence, torture, homelessness, discrimination, underemployment, brain malnutrition, addictions/withdrawal, brain damage from electroshock “therapy” and/or exposure to neurotoxic chemicals in their food, air, water or prescription bottles.

Those labeled as the “mentally ill” are just like us “normals” who have not yet decompensated because of some yet-to-happen, crisis-inducing, overwhelming (however temporary) life situation. And thus we have not yet been given a billable code number (accompanied by the seemingly obligatory – and unaffordable – drug prescription or two signifying we are now chronically mentally ill. Unlabeled, we are likely to remain off prescription drugs but with a label and in “the system”, it is hard to “just say no to drugs.”

The victims of hopelessness-generating situations like simple bad luck, bad circumstances, bad company, bad choices, bad government, big business, and a competitive society that generates a few winners but mostly losers. America tolerates, indeed celebrates, punitive and thus fear-inducing social systems resembling in many ways the infamous police state realities of 20th century European totalitarianism, where people who were different or just dissidents were thought to be abnormal and therefore “disappeared” into insane asylums, jails or concentration camps without just cause or competent legal defense. And many of them were and are drugged with disabling psychoactive chemicals against their will.

The truth is that most, if not all, of BigPharma’s psychotropic drugs are lethal at some dosage level (the LD50, the lethal dose that kills 50% of lab animals, is calculated before efficacy testing is done), and therefore the drugs must be regarded as dangerous. The chronic use of these drugs is a major cause of cognitive disorders, brain damage, loss of creativity, loss of spirituality, loss of empathy, loss of energy, loss of strength, fatigue and tiredness, permanent disability and a multitude of metabolic adverse effects that can readily sicken the body, brain and soul by causing insomnia or somnolence, increased depression or anxiety, delusions, psychoses, paranoia, mania, etc. So before filling the prescription, it is advisable to read the product insert labeling under WARNINGS, PRECAUTIONS, ADVERSE EFFECTS, CONTRAINDICATIONS, TOXICOLOGY, OVERDOSAGE and the ever-present BLACK BOX WARNINGS ABOUT SUICIDALITY.

Long-term, high dosage or combination psychotropic drug usage could be regarded as a chemically traumatic brain injury (TBI) or, as drugs like Thorazine were known in the 1950s and 60s, a “chemical lobotomy”. That is a useful way to conceptualize this serious issue, because such chemically brain-altered patients are often indistinguishable from those who have suffered a physically traumatic brain injuries or been subjected to ice-pick lobotomies which were popular in the 1940s and 50s – before the drugs came on the market.

America has a mental ill health epidemic on its hands that is grossly misunderstood because it is worsening, not by the supposed disease progression, but because of the neurotoxic, non-curative drugs that are somehow regarded as first-line “treatment.”
Read the rest of this article here: http://www.rense.com/general91/edi.htm

« Return to news items


Share

Following 7-year-old’s psychiatric drug-induced suicide—Florida bans foster children from clinical drug trials

Wednesday, August 11th, 2010

Education News
By Pareesha Narang
August 9, 2010

Sixteen months after 7-year-old Gabriel Myers committed suicide while taking psychotropic drugs, the state of Florida has banned allowing any children in the state’s custody from participating in clinical drug trials.

It is unclear if Gabriel was involved in any clinical trials. The doctor who prescribed the medicines to him was conducting clinical trials involving psychotropic drops and the Food and Drug Administration sent him a warning letter earlier this year about overdosing children who were involved in those trials.

The Florida ban was imposed  after the state tried to find out from the FDA if Gabriel or any other foster care child in Florida was a participant in such trials, and the FDA said it could not disclose such information and that mostly they know participants by only coded identifiers.

Though Florida officials had suggested that, under such circumstances, the Federal Food and Drug Administration ban all foster care children from participating in such trials, the agency refused, saying the children might benefit from the drugs.

In a letter last month,  George Sheldon, secretary of the state’s Department of Children and Families (DCF), announced that regardless of the FDA’s stance the state, using “administrative procedures,” was precluding children in state care from participating in such trials.

“Children who come into our care are often the victims of abuse, neglect, and abandonment,” Sheldon said in the letter. “It is therefore imperative that the state do all in its power to stabilize their environment, to protect them from further trauma, and to foster their successful growth into adulthood.”…

Before he hanged himself in his foster home, Gabriel had been taking different drugs for a variety of psychological problems – and some of the drugs were not approved for use in children.  Some of these drugs, including Lexapro, Vyvanse and Symbyax, had “black box” warnings cautioning dangerous side effects such as suicidal thoughts.

Read entire article here:  http://www.educationnews.org/educationnewstoday/97911.html

« Return to news items


Share

Future Kill: Overmedicated and undermined, drug companies are capitalizing off our kids

Thursday, March 25th, 2010

NewsReview.com
March 25, 2010

Young people are being overmedicated and undermined. It is time that we recognize that the deluge of amphetamines and psychotropic drugs being consumed by teenagers may be more of a problem than a solution.

Drug companies are capitalizing off our kids, and why not? They’re the perfect targets. According to a study published in the May/June 2009 issue of Health Affairs, prescriptions for psychiatric drugs increased 50 percent with children in the United States from 1996 to 2006. This is a scary statistic, and one that may be fueled by economic and political forces rather than genuine psychiatric problems among our youth. “Start first with a pharmaceutical industry, that the critics charge, shovels money at the state and federal officials and psychiatric profession in pushing high priced drugs for minors,” wrote Alan Reder in his article “The Other Youth Drug Problem.”

In 2008, psychiatric drug makers raked in a grand total of $29 billion from sales of drugs to treat antidepressant, antipsychotic and ADHD (Attention Deficit Hyperactivity Disorder). While CEOs of these corporations are assembling a hefty retirement fund for themselves, they are not the only ones reaping the benefits of this perverse industry. Parents are now able to declare their kids disabled due to mental illness and receive Social Security disability payments and free medical care. In 2006 alone, more money—$8.9 billion—was spent treating mental disorders in the United States in children ages 0-17 than any other ailment. Some critics even claim these drugs are causing the abnormal behaviors that doctors claim show “disability.”

The seriousness of these drugs that we relentlessly feed children seems overlooked. Beginning in May 2007, the FDA required that all anti-depressants have Black Box Warnings. A drug receives a Black Box Warning when studies have shown that it can have extremely dangerous or even deadly side effects. Anti-depressants often have adverse effects such as increasing the thoughts of suicide in people under 25. A Black Box Warning is the FDA’s strongest safety warning, and yet we supply children as young as 10 with antidepressants that carry these labels.

Read entire article:  http://www.newsreview.com/reno/content?oid=1391594

« Return to news items


Share