Posts Tagged ‘FDA’

Is That Adderall There Is?

Monday, May 9th, 2022

The Wall Street Journal (April 28, 2022) wrote “Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the last year from clinicians working for telehealth startups that have sprung up to treat attention-deficit hyperactivity disorder,” over concerns that too many prescriptions are being written for Adderall and other stimulants and benzodiazepines, suggesting that the drugs are being abused or being fraudulently prescribed from a 30-minute telephone or online interview. Adderall is classified as a Schedule II controlled substance due to its potential for abuse.

Adderall is a psychostimulant of amphetamine and dextroamphetamine that has been linked to suicide and violent behavior and can be habit-forming. The FDA requires stimulants such as Ritalin and Adderall to carry a boxed warning that states the drug is “a federally controlled substance because it can be abused or lead to dependence.”

Approximately 15 million Americans are getting high on prescription drugs, painkillers and psychiatric drugs such as Xanax and the stimulants Ritalin and Adderall. A growing number of teens and young adults are overdosing on the abuse of these “mental health” drugs.

Adderall and other psychostimulants generally increase dopamine levels in the brain by a variety of mechanisms. The body must strictly regulate dopamine levels since both an excess and a deficiency can be problematic. Thus drugs which mess with dopamine are playing Russian Roulette with your brain.

Psychiatrists have known since the beginning of psychopharmacology that their drugs do not cure any disease. Further, there is no credible evidence that mental health is linked to dopamine transport; this is just a public relations theory to support the marketing and sale of drugs. The manufacturers of every such drug state in the fine print that they don’t really understand how it works. These drugs are fraudulently marketed as safe and effective for the sole purpose of earning billions for the psychiatric industry.

These drugs mask the real cause of problems in life and debilitate the individual, so denying him or her the opportunity for real recovery and hope for the future. This is the real reason why psychiatry is a violation of human rights. Psychiatric treatment is not just a failure — it is routinely destructive to the individual and one’s mental health.

No one denies that people can have difficult problems in their lives, that at times they can be mentally unstable. Mental health care is therefore both valid and necessary. However, the emphasis must be on workable mental healing methods that improve and strengthen individuals and thereby society by restoring people to personal strength, ability, competence, confidence, stability, responsibility and spiritual well-being. Psychiatry is not workable.

Alien Mind Wipe

Tranquility or Agitation? There’s a drug for that!

Monday, April 25th, 2022

Agitation, as with many English words, has multiple definitions. Here are a few:
1. moving back and forth with an irregular, rapid, or violent action
2. a feeling of being restless
3. a state of excessive tension and irritability
4. a state of anxiety, emotional disturbance, worry, upset, or nervous excitement
[From Latin agitare, put into motion]

Agitation is a side effect of various psychotropic drugs, such as psychostimulants given to children for so-called ADHD; newer antidepressants such as SSRIs; antipsychotics often called major tranquilizers; anti-anxiety drugs often called minor tranquilizers.

So, pretty much all psychiatric drugs, often prescribed to reduce agitation, have a side effect of agitation. Counter-productive, wouldn’t you say?

The psychiatric billing bible, the Diagnostic and Statistical Manual of Mental Disorders (DSM), specifies some diagnoses related to agitation:

 — Restless legs syndrome
 — 54 individual diagnoses using the word “anxiety”
 — High expressed emotion level within family
 — Adjustment disorder, With mixed disturbance of emotions and conduct

Pretty much anybody, then, can be diagnosed with some form of agitation or anxiety and prescribed one or more psychiatric drugs which have the potential to exacerbate the agitation.

The Latest Agitation Drug

On April 6, 2022 the US Food and Drug Administration (FDA) approved BioXcel Therapeutics dexmedetomidine (Igalmi™) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Dexmedetomidine is a sedative whose safety and effectiveness cannot be established beyond 24 hours from the first dose, usually used to anesthetize a patient or animal before surgery. It inhibits the release of norepinephrine in the brain, stopping propagation of pain signals. They don’t really know how it “works” for agitation, other than the obvious fact that it knocks you out. It’s mostly eliminated from the body within hours. It’s metabolized in the liver by Cytochrome P450 (CYP450) enzymes, so the side effects can be exacerbated by abnormal CYP450 metabolism which can lead to a toxic level causing acute agitation.

The most common side effects (incidence ?5% and at least twice the rate of placebo) were sleepiness, burning or prickling sensations, oral numbness, dizziness, dry mouth, and low blood pressure.

Since it is self-administered by placing the film under the tongue, it’s used by an individual to knock themselves out when they are having an anxiety attack.

Psychiatrists promoting this “treatment” are ecstatic about it, since the patients can knock themselves out whenever they feel the need.

If you feel the need, please contact your local, state and federal representatives and let them know what you think about this.

Nursing Home Psychiatric Abuse of the Elderly

Monday, December 13th, 2021

Almost 300,000 nursing home residents are given harmful antipsychotic drugs each week, even though most have no psychosis to justify it. In 2019 only about 2% had qualifying conditions for such drugs.

The FDA only approves antipsychotics for people who have serious mental diagnoses, such as so-called schizophrenia. The danger of these drugs to older adults can be profound. They come with black box warnings from the FDA, saying they can increase the risk of death in older people, especially those with dementia.

“The high rate of antipsychotics use across our nation’s nursing homes shows that many facilities continue to resort to the use of these potentially dangerous drugs as a chemical restraint — in lieu of proper staffing — which has the potential to harm hundreds of thousands of patients.”

The extensive off-label use of antipsychotics in nursing homes was found in one study to be associated with a 50% increased risk of experiencing a serious fall-related bone fracture.

Some evidence suggests that some nursing homes may be falsifying psychosis diagnoses to avoid citations for inappropriate antipsychotic prescriptions. In 2018 in Missouri, data from the Centers for Medicare & Medicaid Services show there were 108 citations for unnecessary use of antipsychotics in skilled nursing facilities (SNF). This involved 20% of all SNFs in Missouri which received at least one citation; and this had been increasing for at least four years.

“It is reasonable to conclude that the overuse and misuse of antipsychotics is pervasive and continues to occur at unacceptably high rates.”

Such extensive abuse of the elderly is not the result of medical incompetence. The abuse is the result of psychiatry maneuvering itself into an authoritative position over aged care. From there, psychiatry has broadly perpetrated the tragic but lucrative hoax that aging is a mental disorder requiring extensive and expensive psychiatric services.

Recommendation

Insist that any nursing home where an elderly person is to be admitted has a policy of respecting the resident’s wishes not to undergo any form of psychiatric treatment, including psychoactive drugs. Sign a “Psychiatric Living Will” to prepare for this and give a copy to the nursing home staff.

Chantix is in Trouble Again

Wednesday, September 29th, 2021

We’ve been regularly warning about the dangers of Chantix since 2009, and now it’s causing trouble again.

The FDA warned in 2009 that Chantix (generic Varenicline), a psychiatric drug made by Pfizer, can have serious side effects, namely suicide.

Chantix is a benzodiazepine-based anti-anxiety drug promoted for smoking cessation. Benzodiazepines are prescribed to treat anxiety, insomnia or panic attacks, typically for a few weeks to six months; an estimated 50% of patients take them for two months or longer. These drugs have significant risks, because they are highly addictive and can have severe side effects, including heart problems, violence and suicide.

However, in 2016 the FDA removed the Black Box warning, after heavy lobbying from Pfizer claiming that additional data showed that the benefits of Chantix outweighed its adverse side effects (oh, and since its sales had significantly dropped.)

But the adverse side effects did not go away; only the Black Box warning went away.

Chantix Recall

Now (9/17/2021), Pfizer has issued a voluntary recall for all lots of Chantix 0.5mg and 1mg tablets due to the presence of unacceptable N-nitroso-varenicline levels, a suspected cancer-causing agent.

If you smoke, you are susceptible to cancer. If you take anti-smoking drugs, you are susceptible to cancer. But what’s the real danger here?

Chantix was developed to specifically affect nicotinic receptors in the brain, under the unproven theory that this would reduce nicotine craving and block the rewarding effects of smoking. As we’ve warned before, messing with neurotransmitters in the brain is playing Russian Roulette with your mind.

The psychiatric industry considers that smoking cessation therapies are their territory, however this drug masks the real cause of problems in life and debilitates the individual, thus denying one the opportunity for real recovery and hope for the future.

Recognize that the real problem is that psychiatrists fraudulently diagnose life’s problems, apparently such as smoking, as a “mental illness”, and stigmatize this unwanted behavior as a “disease.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax – unscientific, fraudulent and harmful. All psychiatric treatments, not just psychiatric drugs, are dangerous.

Antipsychotic Antics

Wednesday, September 15th, 2021

Paliperidone, sold under the trade name Invega among others, is an atypical antipsychotic. Paliperidone is the primary active metabolite of the older antipsychotic risperidone, although its specific mechanism of action with respect to any psychiatric diagnosis is unknown. It blocks the action of dopamine and serotonin in the brain, which as we’ve previously observed is playing Russian Roulette with the brain.

On September 1, 2021 the US Food and Drug Administration (FDA) approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, manufactured by Janssen Pharmaceuticals) for the treatment of what is fraudulently diagnosed as schizophrenia in adults.

Adverse reactions, or side effects, can include upper respiratory tract infection, neuroleptic malignant syndrome, seizures, high blood sugar, diabetes, decreased blood pressure, fainting, falls, low white blood cell count, headache, tachycardia, somnolence, insomnia, sexual dysfunction, cough, dystonia, akathisia, muscle rigidity, parkinsonism, weight gain, anxiety, indigestion, constipation, and an increased risk of death in elderly people with dementia-related psychosis.

It can be addictive and have acute withdrawal symptoms (euphemistically called “discontinuation syndrome”), including rapid relapse, nausea, vomiting, loss of appetite, restlessness, increased sweating, trouble sleeping, a feeling of the world spinning, numbness, muscle pains, tardive dyskinesia, and psychosis.

The primary reason for prescribing a drug that has only two doses per year is to handle the situation where a patient stops taking their daily prescribed drugs because of their unpleasant side effects.

Psychiatric Fraud

Psychiatrists remain committed to calling “schizophrenia” a mental disorder despite, after a century of research, the complete absence of objective proof that it exists as a physical brain abnormality.

Psychiatry clings tenaciously to antipsychotics as the treatment for “schizophrenia,” despite their proven risks and studies which show that when patients stop taking these drugs, they improve.

The late Professor Thomas Szasz stated that “schizophrenia is defined so vaguely that, in actuality, it is a term often applied to almost any kind of behavior of which the speaker disapproves.”

These are normal people with medical, disciplinary, educational, or spiritual problems that can and must be resolved without recourse to drugs. Deceiving and drugging is not the practice of medicine. It is criminal.

Bear in mind that the drug “treatments” being prescribed are for “disorders” that are not physical illnesses—essentially, they are being prescribed for something that does not exist.

Any medical doctor who takes the time to conduct a thorough physical examination of a child or adult exhibiting signs of what a psychiatrist calls Schizophrenia can find undiagnosed, untreated physical conditions. Any person labeled with so-called Schizophrenia needs to receive a thorough physical examination by a competent medical—not psychiatric—doctor to first determine what underlying physical condition is causing the manifestation.

Any person falsely diagnosed as mentally disordered which results in treatment that harms them should file a complaint with the police and professional licensing bodies and have this investigated. They should seek legal advice about filing a civil suit against any offending psychiatrist and his or her hospital, associations and teaching institutions seeking compensation.

No one denies that people can have difficult problems in their lives, that at times they can be mentally unstable, subject to unreasonable depression, anxiety or panic. Mental health care is therefore both valid and necessary. However, the emphasis must be on workable mental healing methods that improve and strengthen individuals and thereby society by restoring people to personal strength, ability, competence, confidence, stability, responsibility and spiritual well–being. Psychiatric drugs and psychiatric treatments are not workable.

Something is Rotten in Canton

Monday, July 19th, 2021

Let’s Electroshock Children Who Misbehave

In March of 2020 the U.S. Food & Drug Administration (FDA) banned the Judge Rotenberg Educational Center in Canton, Massachusetts from using electric shock devices on their autistic and other mentally troubled children. In July of 2021 a federal appeals court removed the ban. The school is once again electro shocking about 60 students a day.

The school administers electric skin shocks in a form of “aversion therapy” for aggressive or self-injurious behavior. School staff trigger a shock to a child by using a remote control that zaps children with electric current when they misbehave. The school calls this a “medical device.” Since 1987 a state court must determine that such forced treatment is appropriate.

This electrical stimulation device delivers a powerful and painful electric shock to the wearer’s skin in an effort to punish. This school is the only facility in the country that uses coercive electric shock therapy to “treat” individuals who severely self-injure or are aggressive.

The FDA finally recognized in March 2020 (after 20 years) that these devices “present substantial psychological and physical risks and, in fact, can worsen underlying symptoms—while leading to heightened anxiety, depression and post-traumatic stress disorder.”

Unfortunately, the U.S. Court of Appeals for the District of Columbia overturned the FDA ban on July 6, 2021, stating that the ban was a regulation of the practice of medicine, which is outside the FDA’s area of authority.

The History of Abuse

In April 2016, the FDA first proposed banning electrical stimulation devices for self-injurious or aggressive behavior.

In 2018, the media reported that the Judge Rotenberg Educational Center would be allowed to continue administering electric shocks to its special needs students after a judge ruled the procedure conformed to the “accepted standard of care,” in spite of the practice being condemned by disability rights groups and the ACLU.

On December 3, 2018, the Inter-American Commission on Human Rights of The Organization of American States published a Precautionary Measure calling for the school to immediately cease electroshocking special needs children as a disciplinary measure.

In March 2020 the FDA finally determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients, justifying banning the devices for that purpose.

The Appeals Court

The appeals court examined the question, “Does the FDA have legal authority to ban an otherwise legal device from a particular use?”

The court concluded that current law prohibits the FDA from regulating the practice of medicine, and therefore it vacated the FDA’s rule banning electrical stimulation devices for self-injurious and aggressive behavior. There was one dissenting opinion; the Chief Judge found in favor of the FDA. [Read the full court opinion here.]

Of course, the lie in the argument is that electro shocking children is “practicing medicine.” In fact it is torture, not medicine.

The Case Against Torture

The United Nations Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment has remarked that Electro Convulsive Treatment (ECT) amounts to torture. The World Health Organization (WHO) has also stated that there are no indications for the use of ECT on minors. The United Nations Convention on the Rights of Persons with Disabilities (CRPD) calls for a ban on “forced treatment.”

Granted that ECT is more severe than electric skin shocks, just have someone force you to stick your finger into an electric wall socket and tell us that this is not torture.

Disguising social control as medical treatment is a deceit which conceals an abuse.” This is a de facto abuse of power, as it seeks to limit and control the individual instead of helping the individual to get better and improve their conditions in life.

In the United Nations July 24, 2018 Annual Report of the High Commissioner “Mental health and human rights,” it states, “States should ensure that all health care and services, including all mental health care and services, are based on the free and informed consent of the individual concerned, and that legal provisions and policies permitting the use of coercion and forced interventions, including involuntary hospitalization and institutionalization, the use of restraints, psychosurgery, forced medication, and other forced measures aimed at correcting or fixing an actual or perceived impairment, including those allowing for consent or authorization by a third party, are repealed. States should reframe and recognize these practices as constituting torture or other cruel, inhuman or degrading treatment or punishment and as amounting to discrimination against users of mental health services, persons with mental health conditions and persons with psychosocial disabilities.”

The United Nations Universal Declaration of Human Rights, formally adopted on December 10, 1948 states, “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.”

CCHR’s own Mental Health Declaration of Human Rights, written in 1969, states these rights, among others:
“The right to refuse any treatment the patient considers harmful.”
“No person shall be given psychiatric or psychological treatment against his or her will.”

Sign the petition to ban electroshock here.

Qelbree, The Newest ADHD Drug

Monday, June 21st, 2021

The U.S. Food and Drug Administration (FDA) approved a new drug April 2, 2021 for treatment of the fraudulent “disease” Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6 to 17.

Like many other psychiatric drugs, this one also carries an FDA warning:”Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed.”

Qelbree (generic viloxazine hydrochloride) is a non-stimulant drug, although it is a Selective Norepinephrine Reuptake Inhibitor (sNRI), which means that it is really an antidepressant and is similar in operation to other ADHD drugs such as Strattera. The bottom line is that this class of drugs messes with neurotransmitters in the brain, and taking them is playing Russian Roulette with your brain.

Qelbree is an inhibitor of several Cytochrome P450 enzymes, which may intensify the drug’s side effects especially in combination with certain other drugs.

And again, like other similar psychiatric drugs, “The mechanism of action of viloxazine in the treatment of ADHD is unclear.

There is no valid ADHD clinical test for children. There is no valid ADHD clinical test for adults. The ADHD diagnosis does not identify a genuine biological or psychological disorder. The diagnosis is simply a list of behaviors that may appear disruptive or inappropriate, and is essentially just an opinion.

No one denies that people can have difficult problems in their lives, that at times they can be mentally unstable, subject to unreasonable depression, anxiety or panic. Mental health care is therefore both valid and necessary.
However, the emphasis must be on workable mental healing methods that improve and strengthen individuals and thereby society by restoring people to personal strength, ability, competence, confidence, stability, responsibility and spiritual well-being. Psychiatric drugs and psychiatric treatments are not workable.

ADHD Newborn

Tianeptine – An Alternative Worse Than Opioids

Monday, March 15th, 2021

Just when one might have thought that the U.S. was getting a handle on opioid addiction, another harmful and highly addictive opioid-like drug has appeared in widespread use.

The March 2021 issue of Consumer Reports has a comprehensive article about Tianeptine, an illegal drug linked to reports of harm, abuse and deaths.

Tianeptine acts in the brain as an opioid. The FDA says it is illegal and unsafe in the U.S., although it is approved as a prescription antidepressant in some European, Asian, and Latin American countries.

Reports indicate that tianeptine is even more addictive, with more severe withdrawal adverse reactions, than opioids and heroin.

Yet some proponents, possibly motivated by greed if not by malign intentions, are trying to get the FDA to approve it as a prescription drug for depression in the U.S.

Are You Depressed?

Psychiatry is heavily pushing false data about depression.

The fact is, the American Psychiatric Association, the American Medical Association and the National Institute of Mental Health admit that there are no medical tests to confirm mental disorders as a disease but do nothing to counter the false idea that these are biological/medical conditions when in fact, diagnosis is simply done by a checklist of behaviors.

People do experience symptoms of depression. But there are non-harmful, medical alternatives; addictive and harmful psychiatric drugs are not the solution.

Deja Poo - The feeling that you've heard this crap before.
deja poo

Erectile dysfunction drug mistakenly packaged with antidepressant

Monday, December 28th, 2020

Reference: “Erectile dysfunction drug packaged with antidepressant in ‘product mix-up’” [12/10/2020]

Pharmaceutical distributor AvKare issued a voluntary recall of 100 mg tablets of both sildenafil, an erectile disfunction medication [the active ingredient in Viagra], and trazodone, an antidepressant [such as Desyrel], after a mix-up led to some of the prescription drugs being packaged together.

We can think of some lewd suggestions of how this combination might work as an antidepressant, but our better judgment prevails.

Sildenafil is also prescribed for pulmonary arterial hypertension (high blood pressure in the lungs) because it relaxes blood vessels to increase blood flow.

If this goof isn’t bad enough, try putting your mind around the horrific side effects of trazodone, should anyone goof by actually taking it.

Trazodone is what’s known as a “newer antidepressant”. Some of its side effects are: flushing, chest pain, abnormal bleeding, ringing in the ears, dizzyness, fainting, changes in sexual ability, and painful erections.

Some of the side effects of sildenafil are: flushing, chest pain, nosebleeds, ringing in the ears, dizzyness, fainting, painful erections.

Gee, it might be difficult to tell which pill you’ve taken since both were in the same bottle and have the same side effects!

We make fun of it because we think it’s too good of a joke to let be; but the fact is, trazodone is not really a joking matter. Its side effects also include suicidal thoughts or behavior, violent behavior, psychotic episodes, deeper depression (which is ironic for an “antidepressant”), and many more serious adverse reactions.

Trazodone, like other such psychiatric drugs, raises the level of the neurotransmitter serotonin in the brain. Since it is not known exactly how this drug is supposed to work, taking it is playing Russian Roulette with your brain.

Trazodone is also routinely prescribed off-label for insomnia. Care must be used when stopping it, since it can have withdrawal symptoms. Psychiatrists euphemistically call this “discontinuation syndrome.”

We now know that Aaron Alexis, the 34-year-old man accused of killing 12 people in a gun rampage at the Washington Navy Yard September 16, 2013, was taking trazodone.

Adverse reactions should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Recognize that the real problem is not even this awful drug, but that psychiatrists fraudulently diagnose life’s problems as an “illness”, and stigmatize unwanted behavior as “diseases.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax – unscientific, fraudulent and harmful. All psychiatric treatments, not just psychiatric drugs, are dangerous.

It is vital that you, your family and friends watch the video documentary “Making A Killing – The Untold Story of Psychotropic Drugging“. Containing more than 175 interviews with lawyers, mental health experts, the families of psychiatric abuse victims and the survivors themselves, this riveting documentary rips the mask off psychotropic drugging and exposes a brutal but well-entrenched money-making machine. The facts are hard to believe, but fatal to ignore. Watch the video online.

Making A Killing

FDA Now Requires Strongest Warning for Anti-Anxiety Drugs

Monday, October 12th, 2020

The Food and Drug Administration (FDA) is now requiring the most prominent warning label for benzodiazepines, psychotropic drugs commonly prescribed for anxiety.

According to the FDA, more than 92 million prescriptions were written for benzodiazepines in 2019.

Benzodiazepines are prescribed to treat anxiety, insomnia or panic attacks, typically for a few weeks to six months; an estimated 50% of patients take them for two months or longer. Some of the more common brand names are Ativan, Chantix, Klonopin, Librium, Rohypnol, Valium, Versed, and Xanax.

These drugs have significant risks, because they are highly addictive and can have severe side effects, including violence and suicide. Addiction can occur after as little as 14 days of regular use, and withdrawal is often more difficult than withdrawal from heroin. Stopping benzodiazepines abruptly or reducing the dosage too quickly can result in acute withdrawal reactions, including life-threatening seizures.

There is also a “rebound effect” where the individual experiences even worse symptoms after stopping the drug than they had prior to taking the drug.

The FDA’s announcement means makers of benzodiazepines must now have a boxed warning label to include risks of abuse, misuse, addiction, physical dependence and withdrawal reactions.

Psychiatric Fraud and Abuse

Psychiatry’s fraudulent theory that a brain–based, chemical imbalance causes mental illness was invented to sell drugs. That these drugs are now known to be harmful and addictive is all too typical of psychiatric “treatments.”

But what about those who say psychotropic drugs really did make them feel better? Psychotropic drugs may temporarily suppress the pressure that an underlying physical problem could be causing but they do not correct or cure any disease or condition. Once the drug has worn off, the original problem remains, and the body is worse off from the drug’s nerve damage. As a solution or cure to life’s problems, psychotropic drugs do not work. Often real physical conditions can produce similar mental symptoms as the person is experiencing. The correct action on a seriously mentally disturbed person is a full, searching clinical examination by a competent medical doctor to discover and treat the true cause of the problem.

Report any adverse psychiatric drug effects to the FDA’s MedWatch program.