By Anne Harding

Susan Craig’s brother Roger died of a pulmonary embolism in 2007, at age 38. Diagnosed with bipolar disorder in high school, he had been on antipsychotic drugs for years. At the time of his death, he was carrying 280 pounds on his 6-foot-4-inch frame.

Craig, a public relations specialist who works at Columbia University in New York City, knew that Roger’s medications could cause weight gain. But she had never been told that the drugs he was taking might be harming his heart.

“We were never counseled by his psychiatrist or his primary care provider to watch for symptoms of heart disease or any risk of sudden death at all,” Craig says. There’s no evidence that Roger’s medications caused his death, but his family might have been able to get him help sooner if they had known about the risks, Craig explains.
New research published Wednesday in the New England Journal of Medicine shows that antipsychotic drugs are not risk free, and the study’s authors are urging much more caution in their use. The drugs are associated with a risk of sudden cardiac death, particularly at higher doses. Health.com 10 best foods for your heart

Craig’s brother was taking haloperidol, which belongs to an older class of drugs called typical antipsychotics, which have long been known to increase the risk of sudden death due to cardiac causes. He was also on risperidone, a member of a newer class of drugs called atypical antipsychotics, which had been considered safer.

Doctors prescribe these newer medications, originally developed to treat schizophrenia, for a wide variety of problems — from conduct disorder in kids to aggressive behavior in Alzheimer’s patients. In fact, they’ve become so popular that three of them — olanzapine, risperidone, and quetiapine — are among the 10 top-selling drugs worldwide, with $14.5 billion in sales in 2007.

The new study suggests that among patients taking high doses of atypical antipsychotics, there are about 3.3 cases of sudden cardiac death per 1,000 patients per year, which an editorial characterizes as a risk that’s “between ‘moderate’ and ‘low,’ but not ‘rare.’” Health.com: Heart drug may be a cancer fighter

About 325,000 people in the United States each year die of sudden cardiac death, which has an incidence of 0.1 to 0.2 percent per year in adults.

“[The drugs] have potentially very serious side effects,” says Wayne A. Ray, Ph.D., the director of the division of pharmacoepidemiology at Vanderbilt University School of Medicine, in Nashville. “So whenever a decision is made to use one, consideration of potential side effects needs to be made.” Ray and his colleagues found that atypical antipsychotics doubled the risk of sudden death from heart-related causes, most likely by causing disturbances in heart rhythms.

First introduced in the mid-nineties, atypical antipsychotics were praised for having none of the troublesome side effects of their predecessors, including frequent, involuntary movements of the face and mouth that were in some cases irreversible.

But the new study shows that the increased risk of sudden cardiac death seen with the older drugs is nearly identical to that of the newer medications. There had been suspicions that the drugs were risky, especially when used in older patients, but the current study is the first to systematically investigate their association with sudden cardiac death.

Ray and his colleagues reviewed data on Tennessee Medicaid patients, comparing 44,218 people using older typical antipsychotics and 46,089 taking the newer atypical antipsychotics to 186,600 people who had never used the drugs. People with schizophrenia may have a higher rate of cardiac problems, due to smoking and other factors. To account for this, researchers also compared antipsychotic drug users without schizophrenia to non-drug users who had characteristics (in most cases, mood disorders) that made them likely candidates for the drugs.

Overall, people taking typical antipsychotics were at 1.99-times greater risk of sudden cardiac death, while the risk for those on atypical antipsychotics was increased 2.26 times. The increased risk was greater for people on higher doses of the drugs. People who had used the drugs in the past but stopped weren’t at greater risk of sudden cardiac death.

“The drugs are still very effective for conditions that there’s proven evidence for,” says Jeffrey A. Lieberman, M.D., a professor and chair of psychiatry at Columbia University, in New York City, and the director of the New York State Psychiatric Institute, who was not involved with Ray’s research. “They clearly need to still be able to be used. I think this [study] really underscores the need to be very judicious about how these medications are used and whom they’re given to.”

While atypical antipsychotics have been used to ease aggressive behavior for patients with Alzheimer’s disease, for example, they are not approved for this purpose by the U.S. Food and Drug Administration; in fact, in 2005, the FDA issued a warning that these drugs increased the risk of death among elderly people, extending the warning to all antipsychotic drugs last year, notes Sebastian Schneeweiss, M.D., Sc.D., an associate professor of medicine at Harvard Medical School, in Boston, who coauthored an editorial accompanying the current study. Health.com: How is depression in the elderly different from dementia?

Given the lack of better alternatives, these drugs are still widely used in patients with dementia despite the warnings, he adds. But while there’s anecdotal evidence that they will “cool these patients down” and reduce their aggressive behaviors, there’s no scientific evidence that they really help patients or their caregivers, Dr. Schneeweiss says.

In his editorial, Dr. Schneeweiss and coauthor Jerry Avorn, M.D., also of Harvard, call for patients to undergo an electrocardiogram before and shortly after being placed on atypical antipsychotics, to determine if the drugs are causing any heart rhythm disturbances.

For people who must be on these medications, Ray says, it’s essential for their doctors to treat any other conditions, such as high blood pressure, that can harm the heart. “Sudden cardiac death usually occurs when multiple risk factors are present,” he explains. “When you add one, it’s kind of like the straw that broke the camel’s back.”

“Absolutely the lowest dose that works should be used, because we found a strong dose response,” Ray says.

Jamaison Schuler, a spokesperson for Eli Lilly and Company, the maker of Zyprexa, says, “Although the study appears to have important limitations, it provides additional information for practicing physicians to consider as they decide how to treat very complex diseases such as schizophrenia and bipolar disorder.”

The FDA has approved atypical antipsychotics for treating bipolar disorder, Ray adds. But the researcher recommends that physicians first try safer alternatives, such as the mood stabilizer lithium. “That’s a very serious illness, and it has important consequences for patients’ quality of life and relationships,” Ray notes. “If the mood stabilizer doesn’t work, I think it’s very reasonable to consider an antipsychotic, but…other drugs should be considered first.”

Finally, he says, a patient should never stop taking any drug without consulting his or her physician. Nevertheless, anyone taking an atypical antipsychotic for a non-FDA-approved use should consult his physician. “I think off-label use should be undertaken very cautiously, and its frequency should be much less than it is currently,” Ray says. Health.com: Superfoods that can save your health

For Susan Craig, the new research makes it clear that treating serious mental illness must go far beyond just prescribing pills. “We need to be supporting these people in a better, more systematic way,” she says. “There’s no magic pill. It’s treating the whole person.”

URL: http://www.cnn.com/2009/HEALTH/01/15/healthmag.antipsychotic.sudden.death/

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The study conducted at the Vanderbilt University and the Nashville Veterans Affairs Medical Center analyzed Medicaid records (from 1990 to 2005) of nearly 277,000 people aged between 30 and 74 years. While one-third of the people were taking either a newer or an older version of the antipsychotics, two-thirds were nonusers.

For each antipsychotic drug user, two age and sex matched non-users were assessed. During follow-up period, 478 sudden cardiacdefine deaths occurred among those taking the drugs – twice the rate that occurred in the control group, researchers report.

While the results reaffirmed the long held notion that charged older antipsychotic drugs to double the risk of sudden cardiac death
as compared to non-users, a graver result was put forth by the newer medications. The newer versions more than doubled the risk of sudden cardiac deaths, results confirmed.

Moreover, the risk of sudden cardiac death increased as the dosage of antipsychotic medications increased. However, the adverse effects faded once the prescription drugs were withdrawn.

However, the results do not entail that people should stop taking such drugs. “Any prescription is a balancing of risks and benefits. In some cases, there are no good alternative treatments” Dr Wayne A Raya, a Professor of preventive medicine at Vanderbilt and the Nashville veterans’ hospital marked.

“The implication of this study is that physicians need to do a very careful cardiovascular evaluation prior to prescribing these drugs” he added. The drugs should not be used in children and elderly for treating bipolar disorders like attention deficit hyperactivity disorder (ADHD) and Alzheimer’s disease.

Olanzapine (Zyprexa, Eli Lilly), risperidone (Risperdal, Janssen) and quetiapine (Seroquel, AstraZeneca) – the newer atypical drugs are among the 10 top-selling drugs worldwide. The three together, account for about 90 percent of the market.

The U.S. Food and Drug Administration is mulling over slapping a black-box warning — the strongest warning possible — informing about the heightened risk of death in elderly patients.

URL: http://www.themedguru.com/articles/newer_antipsychotics_just_as_risky_as_old-86120080.html

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American psychiatry has been rocked by Congress. Congressional investigators first exposed the financial relationships between high-profile psychiatrists and drug companies. “But now the profession itself is under attack in Congress,” reported the New York Times on July 12, 2008.

Specifically under attack is psychiatry’s premier professional organization, the American Psychiatric Association. The New York Times stated, “In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.”

The American Psychiatric Association is, as the New York Times notes, “the voice of establishment psychiatry.” It publishes the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is the standard diagnostic manual. It also publishes influential professional journals. And it is the primary lobbying organization for American psychiatry.

The president-elect of the American Psychiatric Association is Alan Schatzberg of Stanford University, and his $4.8 million stock holdings in a drug development company raised a red flag for Congressional investigators. Sen. Charles Grassley, R-Iowa, informed the American Psychiatric Association, “I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions.”

One example of how psychiatric treatment practices are corrupted by drug-company money was revealed in a 2007 analysis of Minnesota psychiatrists. The analysis showed that psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs wrote, on average, three times as many prescriptions to children for these drugs as psychiatrists who received less money or none.

The New York Times did track down one psychiatrist in private practice not on the take from drug companies, William Niederhut. Niederhut said that studies have shown that researchers who are paid by drug companies are more likely to report positive findings when evaluating that company’s drugs. Niederhut was upset that drug company influence has pushed psychiatrists to prescribe expensive drugs rather than the off-patent inexpensive ones.

While the truly anti-psychiatry establishment psychiatrists were not quoted by the New York Times, reporters Benedict Carey and Gardiner Harris did provide an important service by using the term establishment psychiatry, which at least gives a clue that there are anti-establishment psychiatrists. Among this group of anti-establishment psychiatrists, two of the most well known are Peter Breggin and Grace Jackson, both of whom have testified at Food and Drug Administration advisory meetings. Breggin and Jackson, for several years, have been reporting that the dangers of psychiatric drugs are downplayed or ignored by establishment psychiatry, that many blockbuster psychiatric drugs are no more effective than sugar pill placebos, and that the chemical imbalance theories that sell these drugs are based on drug-company marketing rather than legitimate science.

Prior to exposing the American Psychiatric Association’s financial dependency on Big Pharma, Congressional investigators had focused on individual establishment psychiatrists’ financial relationships with drug companies. One high-profile example being Joseph Biedeman, about whom the New York Times reported: “A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007.” Biederman and two of his colleagues in the psychiatry department at Harvard Medical School (who received an additional $2.6 million from drug companies from 2000 to 2007), by failing to report income from drug companies while at the same time receiving federal funds from the National Institutes of Health, violated rules designed to police conflicts of interest, according to Sen. Grassley.

I can only hope that Congress and the mainstream media will get around to the most important issue of all: How Big Pharma corruption of psychiatry has eliminated options for people with severe emotional problems who have been failed by establishment psychiatric treatments. One such option that was eliminated is Soteria House, the creation of psychiatrist Loren Mosher.

Loren Mosher (1933-2004) was chief of the National Institute of Mental Health’s Center for the Study of Schizophrenia from 1968 to 1980. Mosher wanted to create an effective and more humane way to help psychiatry’s most seriously troubled patients. Using National Institute of Mental Health funds, Mosher opened the first Soteria House in Santa Clara, California in 1971.

Mosher’s Soteria House experiment is detailed by former Boston Globe reporter Robert Whitaker in Mad in America. In Soteria House, newly diagnosed schizophrenic patients lived medication-free with a young, nonprofessional staff trained to listen to and understand them and provide companionship. Mosher tested his idea that “schizophrenia can often be overcome with the help of meaningful relationships rather than with drugs, and that such treatment would eventually lead to unquestionably healthier lives.”

The Soteria House experiment worked better than Mosher had expected. Over the initial six weeks, patients recovered as quickly as those treated with medication in hospitals. Whitaker notes, “Even more striking, the Soteria patients were staying well longer. Relapse rates were lower for the Soteria group at both one-year and two-year follow-ups. The Soteria patients were also functioning better socially — better able to hold jobs and attend schools.”

Mosher’s success with nonprofessional caregivers and without drugs embarrassed establishment psychiatry. The National Institute of Mental Health choked off funding causing Soteria House to close down. By 1998 Mosher was so disgusted with establishment psychiatry that he wrote a widely publicized letter of resignation from the American Psychiatric Association. Establishment psychiatry, which in recent times usually ignores anti-establishment psychiatrists such as Mosher, had to respond and did so by accusing Mosher of wanting to abolish drug treatments. However, abolishing the option of drug treatment was never Mosher’s goal.

Loren Mosher remains a hero for many anti-establishment consumer- and patient-rights organizations such as MindFreedom. MindFreedom also does not advocate for abolishing the option of drug treatment but instead advocates for truly informed choice as well as for alternatives beyond establishment psychiatric treatments — alternatives such as Soteria House. I recently spoke with two members of MindFreedom, a married couple. Both wife and husband had been diagnosed in the past with schizophrenia. The wife chose to stay on psychiatric drugs, while the husband — who had especially debilitating adverse effects with his psychiatric drugs — chose to go without drugs. Their different paths initially created tension in the marriage but both ultimately quite graciously accepted each other’s decision.

These are the true issues: Do Americans have mental health treatment choices that are informed choices? Why, when Big Pharma corruption has long been known, does it take Congressional investigations for the mainstream media to inform Americans of the financial relationships that drug companies have with high-profile psychiatrists and major psychiatry institutions? And most importantly, when will Americans get real choices when it comes to their mental health?

A real choice is not a choice between Prozac or Zoloft, not between Zyprexa or Risperdal. One example of a real choice is the choice between establishment psychiatry or Soteria House.

Bruce E. Levine, Ph.D., is a clinical psychologist and author of Surviving America’s Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007).
© 2008 Independent Media Institute. All rights reserved.
View this story online at: http://www.alternet.org/story/92264/

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In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Boxed Warnings, the FDA’s strongest, were added. The Boxed Warning will now be added to an older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

“It is important that health care professionals and consumers have the most up-to-date drug safety information,” said Thomas Laughren, M.D., director of the FDA’s Division of Psychiatry Products in the Center for Drug Evaluation and Research. “The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia.”

Antipsychotic drugs commonly are categorized into two classes, the older “conventional” antipsychotics and the newer “atypical” antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or “tics.”

Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called “off-label” use and falls within the practice of medicine.

Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

An explanation of the data and advice for treating patients is available in an FDA notice to health care professionals being issued today.

The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient’s health care professionals about any concerns.

The medications involved in this action are:

For more information, see

FDA Information for Healthcare Professionals: Antipsychotics

http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm

FDA Historical Information on Atypical Antipsychotic Drugs

http://www.fda.gov/cder/drug/infopage/antipsychotics/antipsychotics_historical.htm

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Problem is, Invega isn’t much different than one of J&J’s best-selling drugs, the antipsychotic Risperdal. In late June, Risperdal is scheduled to lose its U.S. patent protection, clearing the way for competing generic copies that are cheaper than Invega, which could further diminish Invega sales, already characterized as a disappointment by J&J.

“I don’t think they have a strong case to make,” says Lieberman, chairman of the psychiatry department at Columbia University’s medical school. “It’s basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it.”

Lieberman’s skepticism is shared by health insurers and points to a rising challenge for drug makers: a tougher market for so-called follow-on drugs. As a result, some companies – including Wyeth (WYE) and Shire PLC (SHPGY) – are setting prices lower or emphasizing improved dosing for the newer drugs to help overcome any skepticism that they’re not much more effective than the older drugs set to lose patent protection.

The growing disdain for follow-on drugs also should reinforce the need for drug makers to come up with truly innovative products, not just marginally better ones, industry watchers say.

Drug companies have used follow-on drugs to try to offset some of the revenue lost when older, top-selling drugs lose patent protection and become exposed to generic knockoffs. The goal is to convince patients, doctors and drug plans to switch to the newer drug that carries a brand-name price and patent protection for years.

A successful example was AstraZeneca PLC’s (AZN) promotion of the Nexium heartburn pill when its older drug, Prilosec, became exposed to U.S. generic competition in 2002. Nexium went on to become a huge blockbuster despite being chemically similar to Prilosec, which became available as both a cheaper generic and over-the-counter product.

Such tactics, however, might not work as well in today’s environment, in which drug-benefit plans are demanding steeper discounts and pushing use of generic drugs in order to lower costs and bolster profit margins.

“We don’t think those opportunities are really going to fly,” Deutsche Bank pharmaceutical analyst Barbara Ryan said. “I think managed-care sees them for what they are, extending the franchise.”

The skepticism around Invega has contributed to a financial disappointment for J&J. The New Brunswick, N.J., healthcare giant hasn’t broken out Invega sales but acknowledges they’ve been below expectations. Invega’s share of U.S. antipsychotic prescriptions was only around 2% for the week ended May 9, according to Verispan, a drug-data marketer. In comparison, Risperdal, which had 2007 sales of more than $4 billion, held a 21% market share.

Insurer Pressure

Some insurers aren’t putting certain follow-on drugs on their lists of preferred drugs, or they’re requiring members to pay higher out-of-pocket costs for these drugs than for other branded and generics.

“It’s a marketing scheme that is not looking at improving healthcare, it’s looking at maintaining their revenues coming in,” said Mirta Millares, in commenting on the industry’s follow-on drug strategy.

Millares is manager of drug information services at Kaiser Permanente, a California health insurer that doesn’t include Invega on its list of preferred drugs. The active ingredient of Invega is derived from that of Risperdal, Millares noted, though it was different enough to get a new patent and regulatory approval.

Minneapolis-based UnitedHealth Group Inc. (UNH), the nation’s largest health insurer by revenue, has Invega on the “third tier” of its preferred drug list, which means members have to pay higher copays than if they were to use other schizophrenia drugs on the first and second tiers. The insurer deemed Invega clinically similar to other atypical antipsychotics.

Clinical studies supporting Invega’s December 2006 Food and Drug Administration approval primarily compared it with a fake drug, or placebo, but not with Risperdal. In 2007, J&J released data showing Invega improved symptoms over AstraZeneca’s Seroquel antipsychotic, which is the market leader for U.S. antipsychotic prescriptions. Also, J&J touts Invega’s long-acting formulation and once-daily dosing.

J&J says it’s not encouraging patients who are stable on Risperdal to switch to Invega. But it had hoped for Invega’s performance to be better by now, making Risperdal’s loss of U.S. market exclusivity next month less painful. “We need to do a better job at drawing a differentiation in a difficult-to-treat population, ” David Norton, J&J’s group chairman of pharmaceuticals, said earlier this month.

Norton said J&J should have ensured Invega had more favorable coverage by drug plans at the time of market launch. Still, he noted that new antipsychotics have historically taken a while to gain acceptance.

J&J has said it plans to seek FDA approval for Invega as a treatment for bipolar disorder, which could bolster sales. It also has applied for FDA approval of a long-acting, injectable version of Invega.

New Marketing Strategies

Despite the challenges, drug-company marketing remains a powerful tool, and it might be too early to write off follow-on campaigns such as that for Invega. The real test may come when Risperdal goes off patent, and J&J reduces its active promotion of Risperdal, leaving sales reps to focus on Invega.

“There are plenty of studies showing physicians are susceptible to marketing practices in their prescribing patterns,” said Aaron Kesselheim, an instructor in medicine at Harvard Medical School who researches drug marketing. “My perception is that hasn’t changed substantially.”

A new marketing campaign that might be meeting with more success is underway at Shire, Basingstoke, U.K., which last year began selling a new drug for attention deficit hyperactivity disorder, Vyvanse. Shire’s top drug, Adderall XR for ADHD, will face generic competition beginning next year.

So far, Vyvanse has captured about 7% of U.S. ADHD drug prescriptions, according to Verispan, which Chief Executive Matthew Emmens calls good progress. Although Shire recently said it expected 2008 Vyvanse sales to come in at the lower end of its forecast range of $350 million to $400 million, Emmens said in an interview he was confident that Vyvanse’s market share will eventually surpass Adderall XR’s peak market share of about 26%.

Emmens noted that Vyvanse is a different chemical entity than Adderall XR, and he thinks its pricing is attractive to health insurers. “In a general nature, the market has become more price sensitive in the last 10 years,” he said. Not incidentally, in the 1990s, Emmens headed the AstraZeneca partnership with Merck & Co. (MRK) that marketed Prilosec and he was involved in the planning for Nexium’s marketing.

The next test of the drug-switch campaign?

Wyeth, Madison, N.J., recently began selling Pristiq, an antidepressant that is chemically similar to Wyeth’s older antidepressant Effexor XR, which is expected to face limited generic competition this year. Deutsche Bank’s Ryan thinks the odds of Pristiq’s success are slim because it appears to offer few benefits beyond those of Effexor.

Wyeth has said Pristiq is effective at treating depression, offers a convenient dose regimen for most patients, and is being priced at a 20% discount to Effexor.

-Peter Loftus; Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com

Url: http://money.cnn.com/news/newsfeeds/articles/djf500/
200805271213DOWJONESDJONLINE000424_FORTUNE5.htm

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Antipsychotic therapy is widely used to manage behavioural problems such as aggression which is sometimes associated with dementia; they are often prescribed prior to admission to a nursing home.

They are commonly used to treat psychosis with conditions such as schizophrenia, bipolar disorder, mania and delusional disorder.

The researchers from the Institute for Clinical Evaluative Sciences (ICES) in Ontario say elderly patients who are given antipsychotic drugs are at an increased risk of having an event that is serious enough to lead to hospitalization or death within a month of starting the therapy.

In a study which looked at all Ontario residents aged 66 years and older diagnosed with dementia, 20,682 older adults with dementia living in the community were compared with another 20,559 individuals living in nursing homes.

In a period stretching from April 1, 1997 to March 31, 2004 the researchers looked at the risk of developing serious events that led to hospitalization or death within 30 days of starting the therapy.

Lead author Dr. Paula Rochon, says it is a double edged sword because while the drug may make life easier in some very difficult situations, it may cause serious harm to the frail elderly and on the other.

Dr. Rochon says caution is needed even when short term therapy is being prescribed, to ensure that the benefits of the drug outweigh the risks for the individual.

The research revealed that 5.2 percent of the nursing homes residents died within a month of being given one of the newer class of antipsychotic drugs, compared to 3.3 percent of residents who did not take the drugs who died within a month.

Among community-dwelling patients, nearly 14 percent taking the drugs suffered a “serious health event” within 30 days, compared to about 4 percent not on the drugs.

The researchers say the study demonstrates the importance of the post-marketing surveillance of new drugs as clinical trials often fail to detect problems that occur when such drugs are used in wider community by frail individuals.

Dr. Rochon says regulatory bodies need to consider their findings in future with regard to deciding the future of such drugs and suggests the research has merely revealed “the tip of the iceburg”.

Antipsychotics first came into use in the 1950s – most of the drugs in the second generation, known as atypical antipsychotics, have more recently been developed and have commonly been in use with Alzheimer patients.

The FDA has now ordered the manufacturers of these newer antipsychotic medications which include Risperdal, Zyprexa and Seroquel, to add a new warning to already existing black-box warnings that the drugs are associated with an increased risk of death related to psychosis and behavioural problems in elderly patients with dementia.

The study also found that the older antipsychotic drugs such as Haldol, posed even higher risks, as much as four times the risk, of serious health problems or death.

The study was funded by the Canadian Institutes for Health Research.

URL: http://www.news-medical.net/?id=38665

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[youtube]http://www.youtube.com/watch?v=0VqP0Knb5fU[/youtube]

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Obviously you can’t go in there cursing like a sailer and demanding to get released because it will not happen.

I was reading an article that I’m about to show to you below. This Psychiatrist named Thomas M. Peterson was accused of improperly prescribing medication to his 2 children patients. The medications that he was improperly prescribing were anti-psychotics. Go to my The Dangers of taking antipsychotics article to find out how dangerous Anti-Psychotics are. I can only speculate that the Anti-Psychotics that Tomas M. Peterson was giving these children were the prescription medication Risperdal, a now approved medication by the FDA to give to children.

He had his medical license taken away and now the state board of medical examiners are reinstating his medical license for some obvious reason.

Bismarck, N. D. (AP) The state Board of Medical Examiners has reinstated the medical license of a Grand Forks psychiatrist accused of improperly prescribing medication to children.

Thomas M. Peterson’s license was reinstated on Wednesday. The board had restricted his license last month after he improperly prescribed anti-psychotic medication to two children.

The board says Peterson has since completed a course at Harvard on child and adolescent pharmacology. His license will remain on probation for three years.

The medical board also placed Lois Freisleben-Cook on probation for three years for improperly prescribing medication. The board ordered the Williston doctor to complete courses in pharmacology, ethics and record-keeping.

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FDA website: FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents

The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.

Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.

“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”

The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.

Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.

The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.

Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person’s mood, energy, and ability to function.

Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.

For more information:

FDA Office of Pediatric Therapeutics
www.fda.gov/oc/opt/default.htm

National Institute of Mental Health—Schizophrenia
www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm

National Institute of Mental Health—Bipolar Disorder
www.nimh.nih.gov/healthinformation/bipolarmenu.cfm

a