Antipsychotic Use in Pregnancy and the Risk for Congenital Malformations

Importance  The frequency of antipsychotic (AP) use during pregnancy has approximately doubled during the last decade. However, little is known about their safety for the developing fetus, and concerns have been raised about a potential association with congenital malformations.

Objective  To examine the risk for congenital malformations overall and cardiac malformations associated with first-trimester exposure to APs.

Design, Setting, and Participants  This nationwide sample of 1 360 101 pregnant women enrolled in Medicaid with a live-born infant constituted the pregnancy cohort nested in the Medicaid Analytic Extract database, which included data from January 1, 2000, to December 31, 2010. Participants were enrolled in Medicaid from 3 months before their last menstrual period through at least 1 month after delivery. Relative risks (RRs) were estimated using generalized linear models with fine stratification on the propensity score to control for the underlying psychiatric disorders and other potential confounders. Data were analyzed during 2015.

Exposures  Use of APs during the first trimester, the etiologically relevant period for organogenesis.

Main Outcomes and Measures  Major congenital malformations overall and cardiac malformations identified during the first 90 days after delivery.

Results  Of the 1 341 715 pregnancies that met inclusion criteria (mean [SD] age of women, 24.02 [5.77] years), 9258 (0.69%) filled at least 1 prescription for an atypical AP and 733 (0.05%) filled at least 1 prescription for a typical AP during the first trimester. Overall, 32.7 (95% CI, 32.4-33.0) per 1000 births not exposed to APs were diagnosed with congenital malformations compared with 44.5 (95% CI, 40.5-48.9) per 1000 births exposed to atypical and 38.2 (95% CI, 26.6-54.7) per 1000 births exposed to typical APs. Unadjusted analyses suggested an increased risk for malformations overall for atypical APs (RR, 1.36; 95% CI, 1.24-1.50) but not for typical APs (RR, 1.17; 95% CI, 0.81-1.68). After confounding adjustment, the RR was reduced to 1.05 (95% CI, 0.96-1.16) for atypical APs and 0.90 (95% CI, 0.62-1.31) for typical APs. The findings for cardiac malformations were similar. For the individual agents examined, a small increased risk in overall malformations (RR, 1.26; 95% CI, 1.02-1.56) and cardiac malformations (RR, 1.26; 95% CI, 0.88-1.81) was found for risperidone that was independent of measured confounders.

Conclusions and Relevance  Evidence from this large study suggests that use of APs early in pregnancy generally does not meaningfully increase the risk for congenital malformations overall or cardiac malformations in particular. The small increase in the risk for malformations observed with risperidone requires additional study.

New Initiative Safely Halts Antipsychotic Use in Dementia Patients

Australian researchers have successfully reduced the use of antipsychotics to treat behavioral and psychological symptoms in dementia patients in 23 long-term care facilities in New South Wales.

In the Halting Antipsychotic use in Long Term care (HALT) Project, regular antipsychotic medication was eliminated from the treatment plan in the majority of participating patients.

Successful stopping of antipsychotics was achieved through training of nurses in long-term care facilities in nonpharmacologic and person-centered approaches to managing behavioral and psychological symptoms of dementia (BPSD).

The research was reported here at the Alzheimer’s Association International Conference (AAIC) 2016.

Nurse “Champions”

“Deprescribing of antipsychotics in long-term care residents with previous BPSD is feasible without reemergence of BPSD,” senior investigator Henry Brodaty, MD, DSc, of the Dementia Collaborative Research Center, University of New South Wales, Sydney, Australia, said in a conference statement.

“Often there can be cultural and logistical barriers to moving away from antipsychotics in aged care settings, but we hope the results of this project will serve as a positive example towards a more person-centered approach globally,” he added.

In an oral presentation, Dr Brodaty noted that nurse “champions” at the participating facilities were trained in how to manage neuropsychiatric symptoms using person-centered, nonpharmacologic approaches. In turn, they trained other nurses in how to handle behavioral problems.

A total of 139 patients completed baseline assessments. Of those, four died and two dropped out, leaving 133 for whom deprescribing protocols were initiated. These patients had been receiving continuous antipsychotic medication. Most started taking antipsychotics after admission to the long-term care facility. On average, the patients had been receiving 2.3 psychotropic medications for about 2 years.

Protocols for incremental decreases in antipsychotic dose were established on an individual basis by pharmacists, with agreement from the patient’s general practitioner.

To participate, “the nursing home had to agree, the family had to agree, and the GP had to agree,” Dr Brodaty said. Deprescribing protocols, he explained, were fairly simple. Essentially, they involved cutting the dose in half every week or 2 weeks. In most cases, it was a one- or two-step process before the patient stopped taking the antipsychotic. Patients were reassessed 3, 6, and 12 months following initial dose reduction.

All 133 patients completed the 3-month follow-up; 118 completed the 6-month follow-up. Data for the 12-month follow-up are still being analyzed.

Of the 125 patients who stopped their antipsychotic, 15 (12%) restarted it in the first 3 months. Of the 118 patients for whom 6-month data were available, 10 (8.5%) restarted antipsychotic therapy; to date, 1 of 68 (1.4%) has restarted medication in the final 6 months, Dr Brodaty reported.

 “So 26 out of 125, or about 20%, represcribed. In other words, almost 80% remained deprescribed,” he noted.

Importantly, Dr Brodaty said, there was no change in scores on the the Neuropsychiatric Inventory or the Cohen-Mansfield Agitation Inventory after antipsychotics were stopped.

“So 80% could stop their antipsychotics, stay off the antipsychotics, and not have reemergence of the symptoms. There was no evidence of drug substitution, particularly benzodiazepines,” he noted.

Interestingly, he said, “when we contacted the GPs and told them we’d like them to be in the study, 22 started deprescribing before we even had the visit with them, so that might be another intervention we might try in the future ― just ring them up.” His statement garnered chuckles from audience.

The study had challenges. “It was difficult to recruit, we had 23 out of 50 nursing homes that we approached, and I can’t tell you the number of GPs who said no; they thought it was too hard. And sometimes the families said they didn’t want to be part of this or rock the boat,” Dr Brodaty said.

Positive Solution to a “Huge” Problem

“There is broad consensus that using antipsychotics to treat dementia symptoms should be a last resort. Unfortunately, we still see a systematic use of these drugs in residential care facilities in the United States and around the world. With the right type of care strategies in place, difficult-to-manage behaviors are greatly reduced, and the need for the drugs is significantly decreased, as was seen in this study,” said Beth Kallmyer, MSW, vice president of constituent services for the Alzheimer’s Association.

“We urge prescribers in the US to assess results of this program and understand how they too can continue to work towards more person-centered, nonpharmacological approaches to manage these symptoms,” Kallmyer added.

In an interview with Medscape Medical News, Maria C. Carrillo, PhD, chief science officer of the Alzheimer’s Association, said the issue of antipsychotic use in long-term care facilities is “huge.”

“Antipsychotic use and black box warnings have been issued, but unfortunately, they are still used widely in nursing home settings, many times because nursing homes are understaffed and overcrowded with patients who have behaviors that are difficult to manage,” Dr Carrillo noted.

“Yet what this study showed is that across their clinics, they were able to reduce the amount of usage of antipsychotics, and they did this with nonpharmacologic approaches and appropriately training their staff to deal with neuropsychiatric symptoms in different ways.”

Antipsychotic Drugs May Triple Kids’ Diabetes Risk.

Antipsychotic medications such as Seroquel, Abilify andRisperdal can triple a child’s risk of developing type 2 diabetes within the first year of usage, according to a new study.

Powerful antipsychotics traditionally were used to treat schizophrenia. Now the majority of prescriptions for antipsychotic medications are for treatment of bipolar disorder, ADHD and mood disorders such as depression, according to prior research.

But antipsychotic drugs make a child much more likely to develop type 2 diabetes than the medications typically prescribed for these other psychiatric conditions, said corresponding author Wayne Ray, director of the division of pharmacoepidemiology at the Vanderbilt University School of Medicine, in Nashville, Tenn.

“We found that children who received antipsychotic medications were three times as likely to develop type 2 diabetes,” Ray said. “It’s well known that antipsychotics cause diabetes in adults, but until now the question hadn’t been fully investigated in children.”

Antipsychotics appear to increase diabetes risk by causing dramatic weight gain in children and by promoting insulin resistance, Ray said.

The boom in the use of antipsychotic medication has been particularly dramatic among children. Antipsychotic prescriptions have increased sevenfold for kids in recent years and nearly fivefold for teens and young adults aged 14 to 20, according to a 2012 study from Columbia University.

For the current study, which was published Aug. 21 in the journal JAMA Psychiatry, the researchers reviewed the records of nearly 29,000 kids aged 6 to 24 in the Tennessee Medicaid program who had recently started taking antipsychotic drugs for reasons other than schizophrenia or related psychoses.

They compared those kids to more than 14,000 matched control patients who had started taking other types of psychiatric medications, including mood stabilizers such as lithium; antidepressants; psychostimulants such as Adderall and Ritalin; alternative ADHD medications such as clonidine and guanfacine; and anti-anxiety drugs known as benzodiazepines.

Within the first year, users of antipsychotic drugs had triple the risk for type 2 diabetes compared to users of other psychiatric medications.

The risk continued to rise with cumulative antipsychotic dose, and remained high for as long as a year after kids were taken off their antipsychotics. When the researchers looked only at kids 17 and younger, the findings held.

“Diabetes can develop relatively soon after beginning these drugs,” Ray said. “We found that the risk was increased within the first year of use, and this is consistent with case reports. The risk may need to be considered even for relatively short periods of use.”

The specific antipsychotic medication used with children didn’t seem to have any effect on reducing risk of diabetes.

“In our study, we didn’t see a difference between different types of drugs,” Ray said. “It may be an effect of the whole class of antipsychotics.” The majority of participants were taking “atypical” antipsychotics, also called second-generation antipsychotics.

Another expert agreed that the study results are cause for concern.

The findings should lead doctors and parents to question the “off-label” use of antipsychotic drugs for conditions other than schizophrenia and psychosis, said Dr. Ken Duckworth, medical director of the National Alliance on Mental Illness.

“There aren’t many antipsychotic medications that are FDA-approved for use in children,” Duckworth said. “When you’re using a compound that doesn’t have an indication, you have to be very careful about the risk/benefit assessment of that medication. You want to make sure you’ve reviewed all the alternative medicines and alternative strategies.”

Ray agreed, arguing that doctors should consider all other alternative treatments before resorting to antipsychotics.

If children must be placed on antipsychotics, then doctors and parents need to keep a close eye on them for early warning signs of diabetes. “Frequent monitoring of the factors that lead to diabetes would be important, including weight and glucose intolerance,” Ray said.

In the past 20 years, growing numbers of U.S. children and teens – especially overweight kids – have been diagnosed with type 2 diabetes, formerly known as adult onset diabetes. This puts them at risk of developing other serious health conditions such as heart disease and kidney disease.

Although the study found an association between the use of antipsychotics and a greatly increased risk of childhood type 2 diabetes, it did not prove a cause-and-effect relationship.


Feds Investigate Antipsychotic Prescribing in Children.

The US Department of Health and Human Services’ Office of Inspector General (OIG) has launched a probe into the prescribing of atypical antipsychotic medications to children under Medicaid.

“We will determine the extent to which children ages 18 and younger had Medicaid claims for atypical antipsychotic drugs during the selected time frame,” the office said in a summary of the plan.

“On the basis of medical record reviews, we will also determine the extent to which the atypical antipsychotic drug claims were for off-label uses and for indications not listed in one or more of the approved drug compendia.”

The time frame is a 6-month period from January to June 2011, when 84,654 children were prescribed antipsychotics in the 5 states selected for the probe, where Medicaid prescriptions are the highest — California, Texas, Illinois, New York, and Florida — said OIG spokesperson Donald White.

Psychiatric experts have been recruited to evaluate approximately 700 of the medical records as part of the ongoing effort, White told Medscape Medical News.

“We are currently conducting the medical record reviews, and the probe will likely last several months, possibly into 2014,” he said.

Lack of Funding for CBT

The probe is focusing on atypical antipsychotics such as aripiprazole (Abilify, Otsuka Pharmaceutical Co., Ltd.), risperidone (Risperdal, Ortho-McNeil-Janssen Pharmaceuticals, Inc.), quetiapine fumarate (Seroquel, AstraZeneca Pharmaceuticals LP), and olanzapine (Zyprexa, Eli Lilly and Company).

A previous probe by the OIG on the overuse of antipsychotics in nursing homes, which resulted in action by the Centers for Medicare and Medicaid Services (CMS) to reduce the use of the drugs by 15%, was launched in response to a request from Congress; however, the new probe was launched by the OIG itself, White said.

Concern over the overprescribing of antipsychotics to children in the Medicaid program is not new — a 2004 study found that children in the healthcare system from low-income families were 4 times as likely to be prescribed antipsychotics as those who were privately insured.

As reported by Medscape Medical News, a more recent study showed that the use of antipsychotic medications among Medicaid-insured children from low- or very-low-income families soared 7-fold to 12-fold between 1997 and 2006.

Among side effects of concern associated with atypical antipsychotics are weight gain and diabetes, and little is known on the long-term neurologic effects of the drugs used in early childhood.

One important reason why the prescribing of antipsychotics to children is believed to be higher among children under Medicaid coverage is that the system simply is not as accommodating to the best-known alternative — cognitive-behavioral therapy, according to Pensacola, Florida–based child psychiatrist Scott R. Benson, MD.

“The reimbursement for the kind of cognitive-behavioral therapy that could help these children is lower with Medicaid, so children who are covered by private insurance may have access to a better range of therapies,” he told Medscape Medical News.

“But part of this is our own fault on a professional level — we [psychiatrists] have not made a good enough case for the value of psychotherapy in helping children,” added Dr. Benson, who is a member of the American Psychiatric Association.

Infants, Toddlers Prescribed Atypicals

Dr. Benson said clinicians too often associate the option of cognitive-behavioral therapy with being arduous and time-consuming.

“The patient doesn’t necessarily have to be coming in 3 times a week over 10 years — there is plenty of evidence showing, especially for children who have been traumatized, that even short-term therapy, maybe once-a-week visits over 20 weeks, can be a very effective treatment.”

Among the more alarming figures regarding prescribing atypical antipsychotics to children are those showing prescriptions to the very young, including toddlers and infants.

As reported in a recent article in the Wall Street Journal, the inspector general’s 5-state probe found 482 children aged 3 years and younger who were prescribed antipsychotics during the 6-month period in question, including 107 children who were aged 2 years and younger.

Six children prescribed the drugs were younger than 1 year, and 1 was listed as being 1 month old.

Importantly, the records did not identify the diagnoses involved, and Dr. Benson speculated that some may have included children with certain severe disorders, such as autism.

“It’s important to remember that the majority of these prescriptions are not even written by child psychiatrists,” he said. “In the case of the very young children, these may have represented prescriptions from neurologists who were treating patients with severe autistic disorders.”

Quick Fix?

Others, however, may have been practitioners such as pediatricians, who, facing heavy patient loads, are often under pressure to make a quick diagnosis and reach for a quick fix — an antipsychotic.

“A practitioner may observe a few behaviours, say ‘that’s terrible,’ and simply prescribe something the patient doesn’t really need because there wasn’t enough time or interest in doing the kind of good, standard evaluation that all of us would expect for our children,” Dr. Benson said.

“Certainly all patients deserve that, regardless of their insurance situation.”

A complex range of psychiatric issues may cause a child to appear dysregulated, and a full evaluation is essential before writing that prescription, said Mary Margaret Gleason, MD, an assistant professor in child psychiatry and pediatrics at Tulane University in New Orleans, Louisiana.

“Especially in younger children, the causes of impulsive or disruptive behaviors can be quite broad,” she toldMedscape Medical News.

“A thorough assessment looking into psychological, environmental, and biological factors that might cause someone to look impulsive and disruptive needs to be done to know what is driving the impulsivity.”

“One of the biggest things that needs to be looked at, for instance, is if the child has been exposed to trauma, and if someone is considering using a medication that has as long a list of potential side effects as atypical antipsychotics, they do need to really be certain of what they’re treating first.”

Source: Medscape/com


FDA Investigating Two Deaths Linked to Schizophrenia Drug.

The FDA is investigating the deaths of two patients following injection of the long-acting antipsychotic olanzapine pamoate (Zyprexa Relprevv). The deaths occurred 3 to 4 days after injection, well beyond the 3-hour monitoring period that the drug requires.

Postmortem blood tests revealed very high levels of olanzapine. The drug’s label includes a warning about post-injection delirium sedation syndrome, the FDA notes. This occurs when the drug enters the bloodstream too quickly, leading to sedation and possibly coma, as well as delirium. High doses can also lead to cardiopulmonary arrest and arrhythmias, according to the agency.

The FDA is reminding providers who prescribe olanzapine pamoate to follow its Risk Evaluation and Mitigation Strategy, which includes injection at a certified facility, at least 3 hours of monitoring following injection, and accompaniment to one’s home afterward.

Source: FDA 

A Call for Caution on Antipsychotic Drugs.

You will never guess what the fifth and sixth best-selling prescription drugs are in the United States, so I’ll just tell you: Abilify and Seroquel, two powerful antipsychotics. In 2011 alone, they and other antipsychotic drugs were prescribed to 3.1 million Americans at a cost of $18.2 billion, a 13 percent increase over the previous year, according to the market research firm IMS Health.

Those drugs are used to treat such serious psychiatric disorders as schizophrenia, bipolar disorder and severe major depression. But the rates of these disorders have been stable in the adult population for years. So how did these and other antipsychotics get to be so popular?

Antipsychotic drugs have been around for a long time, but until recently they were not widely used. Thorazine, the first real antipsychotic, was synthesized in the 1950s; not just sedating, it also targeted the core symptoms of schizophrenia, like hallucinations and delusions. Later, it was discovered that antipsychotic drugs also had powerful mood-stabilizing effects, so they were used to treat bipolar disorder, too.

Then, starting in 1993, came the so-called atypical antipsychotic drugs like Risperdal, Zyprexa, Seroquel, Geodon and Abilify. Today there are 10 of these drugs on the market, and they have generally fewer neurological side effects than the first-generation drugs.

Originally experts believed the new drugs were more effective than the older antipsychotics against such symptoms of schizophrenia as apathy, social withdrawal and cognitive deficits. But several recent large randomized studies, like the landmark Catie trial, failed to show that the new antipsychotics were any more effective or better tolerated than the older drugs.

This news was surprising to many psychiatrists — and obviously very disappointing to the drug companies.

It was also soon discovered that the second-generation antipsychotic drugs had serious side effects of their own, namely a risk of increased blood sugar, elevated lipids and cholesterol, and weight gain. They can also cause a potentially irreversible movement disorder called tardive dyskinesia, though the risk is thought to be significantly lower than with the older antipsychotic drugs.

Nonetheless, there has been a vast expansion in the use of these second-generation antipsychotic drugs in patients of all ages, particularly young people. Until recently, these drugs were used to treat a few serious psychiatric disorders. But now, unbelievably, these powerful medications are prescribed for conditions as varied as very mild mood disorders, everyday anxiety, insomnia and even mild emotional discomfort.

The number of annual prescriptions for atypical antipsychotics rose to 54 million in 2011 from 28 million in 2001, an 93 percent increase, according to IMS Health. One study found that the use of these drugs for indications without federal approval more than doubled from 1995 to 2008.

The original target population for these drugs, patients with schizophrenia and bipolar disorder, is actually quite small: The lifetime prevalence of schizophrenia is 1 percent, and that of bipolar disorder is around 1.5 percent. Drug companies have had a powerful economic incentive to explore other psychiatric uses and target populations for the newer antipsychotic drugs.

The companies initiated dozens of clinical trials to test these drugs against depression and, more recently, anxiety disorders. Starting in 2003, the makers of several second-generation antipsychotics (also known as atypical neuroleptics) have received F.D.A. approval for the use of these drugs in combination with antidepressants to treat severe depression, which they trumpeted in aggressive direct-to-consumer advertising campaigns.

The combined spending on print and digital media advertising for these new antipsychotic drugs increased to $2.4 billion in 2010, up from $1.3 billion in 2007, according to Kantar Media. Between 2007 and 2011, more than 98 percent of all advertising on atypical antipsychotics was spent on just two drugs: Abilify and Seroquel, the current best sellers.

There is little in these alluring advertisements to indicate that these are not simple antidepressants but powerful antipsychotics. A depressed female cartoon character says that before she starting taking Abilify, she was taking an antidepressant but still feeling down. Then, she says, her doctor suggested adding Abilify to her antidepressant, and, voilà, the gloom lifted.

The ad omits critical facts about depression that consumers would surely want to know. If a patient has not gotten better on an antidepressant, for instance, just taking it for a longer time or taking a higher dose could be very effective. There is also very strong evidence that adding a second antidepressant from a different chemical class is an effective and cheaper strategy — without having to resort to antipsychotic medication.

A more recent and worrisome trend is the use of atypical antipsychotic drugs — many of which are acutely sedating and calming — to treat various forms of anxiety, like generalized anxiety disorder and even situational anxiety. A study last year found that 21.3 percent of visits to a psychiatrist for treatment of an anxiety disorder in 2007 resulted in a prescription for an antipsychotic, up from 10.6 percent in 1996. This is a disturbing finding in light of the fact that the data for the safety and efficacy of antipsychotic drugs in treating anxiety disorders is weak, to say nothing of the mountain of evidence that generalized anxiety disorder can be effectively treated with safer — and cheaper — drugs like S.S.R.I. antidepressants.

There are a small number of controlled clinical trials of antipsychotic drugs in generalized anxiety or social anxiety that have shown either no effect or inconsistent results. As a consequence, there is no F.D.A.-approved use of an atypical antipsychotic for any anxiety disorder.

Yet I and many of my colleagues have seen dozens of patients with nothing more than everyday anxiety or insomnia who were given prescriptions for antipsychotic medications. Few of these patients were aware of the potential long-term risks of these drugs.

The increasing use of atypical antipsychotics by physicians to treat anxiety suggests that doctors view these medications as safer alternatives to the potentially habit-forming anti-anxiety benzodiazepines like Valium and Klonopin. And since antipsychotics have rapid effects, clinicians may prefer them to first-line treatments like S.S.R.I. antidepressants, which can take several weeks to work.

Of course, physicians frequently use medications off label, and there is sometimes solid empirical evidence to support this practice. But presently there is little evidence that atypical antipsychotic drugs are effective outside of a small number of serious psychiatric disorders, namely schizophrenia, bipolar disorder and treatment-resistant depression.

Let’s be clear: The new atypical antipsychotic drugs are effective and safe. But even if these drugs prove effective for a variety of new psychiatric illnesses, there is still good reason for caution. Because they have potentially serious adverse effects, atypical antipsychotic drugs should be used when currently available treatments — with typically fewer side effects and lower costs — have failed.

Atypical antipsychotics can be lifesaving for people who have schizophrenia, bipolar disorder or severe depression. But patients should think twice — and then some — before using these drugs to deal with the low-grade unhappiness, anxiety and insomnia that comes with modern life.

Source: NY Times


Why have Antipsychotic Prescriptions in Children Skyrocketed?

Thanks to aggressive marketing techniques, pharmaceutical companies are raking in profits from atypical antipsychotic medications – drugs originally approved for mental illnesses that are as serious as they are rare.

It’s no surprise then that a major portion of the sales of these types of “hard-core” psychiatric drugs come from off-label uses. Drugs such as Seroquel, Zyprexa, Risperdal and Abilify are now increasingly prescribed by psychiatrists and primary-care doctors to treat conditions they were never intended or approved for, such as:

Illegal Marketing Largely Responsible for Skyrocketing Misuse of Dangerous Antipsychotics in Children

Most of the atypical antipsychotics were approved in the 1990’s, at which time they were reserved for a very small minority of serious mental illnesses; primarily schizophrenia and bipolar disorder – diseases afflicting an estimated three percent of Americans. More recently, some atypical antipsychotics have also been approved for the treatment of severe depression. Shockingly, children as young as 18 months are now receiving antipsychotic drugs, despite the fact that the diseases they’re designed to treat rarely develop before adolescence.

Drug makers are increasingly getting caught in the act of illegal marketing of this class of drugs:

  • In July, GlaxoSmithKline was found guilty of the largest health fraud in US history, and was fined $3 billion after pleading guilty to three counts of criminal misdemeanor and other civil liabilities relating to a number of different drugs, including Paxil and Wellbutrin
  • In June, Johnson & Johnson agreed to pay $2.2 billion for illegally marketing its drug Risperdal
  • In 2009 Eli Lilly was fined $1.4 billion for the illegal marketing of its antipsychotic drug Zyprexa
  • Bristol Myers Squibb was fined $515 million in 2007 to settle charges of illegal marketing of Abilify to child psychiatrists
  • Pfizer paid $301 million for illegal marketing of its drug Geodon, and
  • AstraZeneca has paid out $520 million to settle illegal marketing charges of Seroquel

In each of these cases, the drug manufacturers were targeting children, despite the fact that none of the drugs in question were approved for use in that age group. To understand how effective these illegal marketing schemes are, consider that sales of antipsychotic drugs to children have increased eight-fold since 1993. Sales to teens have quintupled, while adult sales doubled in the same time frame. In 2008 alone, an estimated $6 billion was spent on off-label antipsychotics in the US, of which $5.4 billion was for uses based on uncertain evidence!

According to the featured article in Time:1

“There is much evidence that the vast increases in atypical antipsychotic prescribing in recent decades were fueled by the aggressive marketing tactics of drug companies. In recent years, every major manufacturer of atypical antipsychotics has been involved in the illegal marketing of the drugs (while doctors can prescribe drugs off label, it is against the law for drug makers to market them for off-label uses), each ultimately paying hundreds of millions to billions of dollars in fines for their sales and marketing tactics. The settlements with the U.S. government were among the largest in history.”

“Trends Signal Need to Re-Evaluate Clinical Practice Patterns”

A recently published study2 found that nearly two-thirds of all antipsychotic drugs prescribed to children between 2005 and 2009 were for the treatment of ADHD and other disruptive behavior disorders. In teens, 34 percent of all antipsychotic prescriptions were for these conditions. These are astounding statistics when you consider the fact that there’s virtually no data supporting the use of these kinds of drugs in children, or for those conditions. The authors seem to agree, concluding:

“In light of known safety concerns and uncertainty over long term risks and benefits, these trends may signal a need to re-evaluate clinical practice patterns.”

According to Time:

“‘As the actual evidence base that would support [such off-label prescriptions of antipsychotics] is scant to non-existent, and the evidence of permeating undue influence of pharma on prescribing practices in psychiatry is abundant, one is led to the conclusion that this is another example of irrational prescribing that can be traced to both the overt and tacit influence of [drug companies] on practitioners,’ says Dr. Bruce Perry, a senior fellow at the ChildTrauma Academy…

Perry testified for the state of Texas in a case that resulted in a $158 million settlement with Johnson and Johnson in January to resolve claims that it fraudulently marketed Risperdal and swindled the state’s Medicaid program. One aspect of the case involved misleading claims about the drug’s effectiveness for behavior disorders in children.”

The Hidden Cause of Psychiatric Disorders Almost No One Considers

American children are the most medicated children in the world. For example, they get three times more prescriptions for antidepressants and stimulants, and up to double the amount of antipsychotic drugs than kids from Germany and the Netherlands.

How can we, as a society, continue to allow corporate profits to come before lives, and even before children’s lives?

It’s just not right. I don’t even advocate giving children cough syrup, Tylenol or antibiotics, as these alone can be harmful. But when you’re talking about powerful psychotropic, mind-altering drugs that in no way shape or form even begin to address the underlying cause of the disease. You’re entering an entirely different ballgame with these dangerous drugs. Unfortunately, psychiatric conditions are primarily believed to be the result of chemical dysfunction in your brain, or in some cases hereditary and therefore out of your control. Many fail to realize that:

  1. Your lifestyle can override genetic predispositions, and
  2. Your lifestyle can be a major underlying cause of that chemical imbalance or dysfunction.

If you or your child is suffering from an emotional or mental challenge, please seek help, but do so from someone who does not regard psychotropic drugs as a first line of defense. It will be very helpful if you first optimize your or your child’s diet and lifestyle as this will significantly improve the likelihood of any successful natural intervention.

The Importance of Probiotics for Mental Health

An important factor to address is gut health. It’s important to realize that children are now increasingly BORN with damaged gut flora – courtesy of less than ideal lifestyle choices by the child’s mother. Many aspects of our modern lifestyle contribute to destroying your all-important gut flora, including:

Antibiotics; both from prescription antibiotics, and from consuming antibiotic-laden foods like non-organic meat, chicken, and milk from cows raised in Confined Animal Feeding Operations Processed foods. Not only are processed foods void of “live” beneficial bacteria to begin with, the high sugar and grain content serve as fuel for the growth of pathogenic anaerobic bacteria, fungi, and yeast, which competitively inhibit your good bacteria
Genetically engineered foods and agricultural chemicals Aspartame, which inactivates digestive enzymes and alters gut barrier function, has been found to destroy up to 50 percent of your beneficial gut flora
Chlorinated and/or fluoridated water Oral contraceptives (birth control pills)


In a very real sense, you have two brains: one inside your skull and one in your gut. While they may seem very different, these two organs are actually created out of the same type of tissue. During fetal development, one part turns into your central nervous system while the other develops into your enteric nervous system. Your vagus nerve – the tenth cranial nerve that runs from your brain stem down to your abdomen – connects these two organs together.

Your gut actually produces about 90 percent of the neurotransmitter serotonin – thought to play an important role in many psychiatric conditions, in addition to having a beneficial influence on your mood in general – than your brain does, so optimizing your child’s gut flora may indeed have tremendous benefit for his or her psychological health.

Behavioral problems in children – including what might appear to be serious mental disorders – are very frequently related to improper diet, emotional upset and exposure to toxins.

Increasingly, scientific evidence shows that nourishing your gut flora with the beneficial bacteria found in traditionally fermented foods (or a probiotic supplement) is extremely important for proper brain function, and that includes psychological well-being and mood control. The reason I am more fond of using fermented foods as a source of beneficial bacteria is leverage. A small serving of fermented vegetables can provide you with more than 100 times the amount you would get from a typical dose of a probiotics supplement. You can get trillions of bacteria instead of billions, and consuming a variety of fermented foods will provide you with a much wider variety of probiotics strains as well.

Dr. Natasha Campbell-McBride has successfully demonstrated the power and effectiveness of this theory. In her Cambridge, England clinic, she treats children and adults with a range of conditions, including autism, neurological disorders, psychiatric disorders, immune disorders, and digestive problems using the GAPS (Gut and Psychology Syndrome) Nutritional Program, which she developed.

Her GAPS theory – which is fully explained in her excellent book, Gut and Psychology Syndrome – is an elegant description of how such conditions can develop as a direct result of gastrointestinal toxicity.

Pathogenic microbes can damage the integrity of your gut wall, and once your beneficial gut flora has been crowded out by pathogenic microbes inside your digestive tract, toxins and microbes can reach your bloodstream. And once they’re in your bloodstream, they can reach your brain… Gut and Psychology Syndrome (GAPS) may manifest as symptoms that can fit the diagnosis of a wide range of conditions and syndromes, including obsessive-compulsive disorder, ADD/ADHD, dyslexia and dyspraxia.

Could a B Vitamin be the Answer for Some Psychosis?

The book Niacin: The Real Story, co-authored by Dr. Andrew Saul and Abram Hoffer M.D., Ph.D., who has published over 600 reports and articles as well as 30 books, describes the psychiatric benefits of niacin. Dr. Hoffer died in 2009 at the age of 91, but he successfully treated many thousands of patients with high dose niacin for psychotic disorders. His work includes some very compelling evidence to support treating most psychotic disorders as a vitamin B3 deficiency.

Considering the fact that niacin is very inexpensive and has virtually no dangerous side effects, it would certainly be worth consideration for anyone who has a family member with this mental health challenge. I would also highly recommend picking up this $12 book at Amazon and learning more about its use.

Correcting Behavioral Problems Without Drugs

Here are a few additional guidelines to help you address underlying toxins in your child, without, or at least BEFORE, you agree to any kind of drug therapy:

  1. Severely limit or eliminate fructose from your child’s diet as sugar/fructose has been linked to mental health problems such as depression and schizophrenia.
  2. Avoid giving your child ANY processed foods, especially those containing artificial colors, flavors, and preservatives. This includes lunch meats and hot dogs, which are common food staples in many households.
  3. Replace soft drinks, fruit juices, and pasteurized milk with pure water. This is HUGE since high fructose corn syrup is a primary source of calories in children.
  4. Make sure your child is getting large regular doses of healthy bacteria, either with high quality fermented organic foods and/or high quality probiotic supplements.
  5. Give your child plenty of high-quality, animal-based omega-3 fats like krill oil. Also, make sure to balance your child’s intake of omega-3 and omega-6 fats, by simultaneously limiting their intake of vegetable oils.
  6. Include as many whole organic foods as possible in your child’s diet, both to reduce chemical exposure and increase nutrient content of each meal.
  7. Also reduce or eliminate grains from your child’s diet. Yes, even healthy organic whole grains can cause problems as they too break down into sugars.

Additionally, whole wheat in particular contains high amounts of wheat germ agglutinin (WGA), which can have adverse effects on mental health due to its neurotoxic actions. Wheat also inhibits production of serotonin, the largest concentration of which can, again, be found in your intestines, not your brain. Try eliminating them first for 1-2 weeks and see if you don’t notice a radical and amazing improvement in your child’s behavior.

  1. Avoid artificial sweeteners of all kinds.
  2. Make sure your child gets plenty of exercise and outdoor playtime.
  3. Get them out into the sun to help maintain optimal vitamin D levels. Scientists are now beginning to realize vitamin D is involved in maintaining the health of your brain, as they’ve recently discovered vitamin D receptors in the brain, spinal cord, and central nervous system. There’s even evidence indicating vitamin D improves your brain’s detoxification process. For children and pregnant women, getting enough vitamin D is especially crucial, as it may play a major role in protecting infants from autism.

If natural sun exposure is not feasible, for whatever reason, you can use either a safe tanning bed or an oral vitamin D3 supplement. For more details on how to safely optimize your and your child’s vitamin D levels, please see this previous article.

  1. Give your child a way to address his or her emotions. Even children can benefit from the Emotional Freedom Technique (EFT), which you or an EFT practitioner can teach them to use.
  2. Prevent exposure to toxic metals and chemical by replacing personal care products, detergents and household cleaners with all natural varieties. Metals like aluminum, cadmium, lead and mercury are commonly found in thousands of different food products, household products, personal products and untold numbers of industrial products and chemicals. The presence of toxic metals in your child’s body is highly significant for they are capable of causing serious health problems by interfering with normal biological functioning. The health effects range from minor physical ailments to chronic diseases, and altered mood and behavior.



Soure: Dr. Mercola