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A November 12, 2009 Bloomberg.com story discusses how the use of widely prescribed antipsychotic drugs to combat dementia, actually cause more harm than good. British patients with dementia too often get dangerous antipsychotic drugs, causing as many as 1,800 deaths and 1,620 strokes a year, a report commissioned by the U.K. Department of Health uncovered.

The government announced a plan to curb overuse of the medicines, including Eli Lilly & Co.’s Zyprexa, Johnson & Johnson’s Risperdal, Bristol-Myers Squibb Co.’s Abilify, AstraZeneca Plc’s Seroquel and Pfizer Inc.’s Geodon. The drugs, designed to treat schizophrenia, are often inappropriately used a first-line therapy to quell behavioral problems in people with dementia, according to the report by Sube Banerjee, professor of mental health at King’s College London Institute of Psychiatry.

An estimated 180,000 elderly people with dementia in England are given the antipsychotic drugs each year, and just 20% improve because of the treatment, Banerjee said at a press conference in London. As many as two-thirds of the patients don’t derive any benefit from the pills, which boost the risk of early death and carry a range of side effects including sedation, stiff muscles, and trouble thinking and speaking clearly, the report found.

“We need to be sure that only the people who benefit from these drugs get them, and they get them at the lowest possible dose for the shortest period of time,” Banerjee said. “It is clear that these medications are being prescribed to deal with behavior and psychological symptoms in dementia rather than just for psychosis,” he wrote in the report.

Behavioral Therapies

All of the medications, including older, generic drugs such as Haldol and Thorazine, have the same effect, Banerjee said. As a result, doctors can’t switch patients from one medication to another to solve the problem.

Instead, they need to focus on basic techniques, such as trying to determine the cause of a patient’s agitation, and behavioral therapies to improve the situation, he said. In some cases, simple problems such as lack of sleep or hunger can be the culprit, he said.

“It is unacceptable that antipsychotic drugs are routinely prescribed to people with dementia,” said Health Minister Phil Hope. “I know we’re not going to reduce the use of these drugs overnight, but it can be done.”

The government accepted the recommendations from Banerjee and plans to hire a national clinical director for dementia to oversee efforts to improve care and reduce unnecessary drug use, Hope said at the press conference.

‘Chemical Restraints’

“The use of these chemical restraints really should be a last resort,” said Neil Hunt, chief executive officer of the Alzheimer’s Society. “We’ve got a culture and an ingrained pattern of care to shift here.”

In 2005, the FDA required makers of antipsychotics to include in dosage instructions a prominent warning surrounded by a black box about the increased risk of premature death in elderly patients with dementia. An English study released two years later found patients getting the drugs die six months earlier than those who don’t receive them.

A new study released during the week of October 26, 2009, found that children on widely used psychiatric drugs can quickly gain an alarming amount of weight, with many put on nearly 20 pounds and become obese within just 11 weeks. “Sometimes this stuff just happens like an explosion. You can actually see them grow between appointments,” said Dr. Christopher Varley, a psychiatrist with Seattle Children’s Hospital who called the study “sobering.”

Weight gain is a known possible side effect of the anti-psychotic drugs which are prescribed for bipolar disorder and schizophrenia, but also increasingly for autism, attention deficit disorders and other behavior problems. The new study in mostly older children and teens suggests they may be more vulnerable to weight gain than adults. The study also linked some of these drugs with worrisome increases in blood fats including cholesterol, also seen in adults. Researchers tie these changes to weight gain and worry that both may make children more prone to heart problems in adulthood.

The research is the largest in children who had just started taking these medicines, and provides strong evidence suggesting the drugs, not something else, caused the side effects, said lead author Dr. Christoph Correll of North Shore-Long Island Jewish Health System in Glen Oaks, New York.  But because these drugs can reduce severe psychiatric symptoms in troubled children, “We’re a little bit between a rock and a hard place,” he said.

The authors of the study said their results show that children on the drugs should be closely monitored for weight gain and other side effects, and that when possible, other medicines should be tried first.

The study appears in the Journal of the American Medical Association. It involved 205 New York City-area children from 4 to 19 years old who had recently been prescribed one of the drugs; the average age was 14. Depending on which of four study drugs children used, they gained between about 10 and 20 pounds on average in almost 11 weeks; from 10% to 36%t became obese.

The drugs are Abilify, Risperdal, Seroquel and Zyprexa. Of the four, Seroquel and Zyprexa are not yet approved for children, and they had the worst effects on weight and cholesterol. However, a government advisory panel recently voted in favor of pediatric use for the two drugs, and the Food and Drug Administration often follows its advisers’ recommendations.

The drugs’ makers said these problems are known side effects but emphasized the drugs’ benefits in helping patients cope with serious mental illness.

The four drugs have been considered safer than older anti-psychotic drugs, which can cause sometimes permanent involuntary muscle twitches and tics. That has contributed to widespread use of the newer drugs, including for less severe behavior problems, a JAMA editorial said.

The number of children using these drugs has soared to more than 2 million annually, according to one estimate.

Doctors “should not stretch the boundaries” by prescribing the drugs for conditions they haven’t been proven to treat, said Varley, co-author of the editorial.

Why these drugs cause weight gain is uncertain but there’s some evidence that they increase appetite and they may affect how the body metabolizes sugar, said Jeff Bishop, a psychiatric pharmacist at the University of Illinois at Chicago. The drugs also can have a sedation effect that can make users less active.

Recent trail data from the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer’s disease (CATIE-AD), reveals that elderly patients with Alzheimer’s disease who are treated with second-generation antipsychotics should be monitored closely for weight gain and lipid abnormalities.

The 36-week trial included 421 outpatients with Alzheimer’s disease who were treated for delusions and aggression. The average patient age was 78 years and 56 % were female. The findings are reported in the online edition of the American Journal of Psychiatry.

Seventy-two patients had no exposure to the study drugs, while the remaining subjects were assigned to treatment with Zyprexa (generic: olanzapine), Seroquel (generic: quetiapine), and Risperdal (generic: risperidone); and they could switch antipsychotic medication during the trial.

Female subjects gained an average of 0.14 pounds per week and body mass index increased by 0.03 per week, Dr. Lon S. Schneider at the University of Southern California, Los Angeles, and associates report. Changes in weight and BMI among males were not statistically significant.

The duration of antipsychotic use by women was significantly associated with weight gain. “The prevalence of significant weight gain was 10 percent, 17 percent, and 20 percent among patients with less than 12 weeks, 12 to 24 weeks, and greater than 24 weeks of use compared to 7 percent with no use,” Schneider’s team reports.

The effect on weight was significant for olanzapine and quetiapine, but less so for risperidone. Olanzapine was also significantly associated with increased waist circumference and decreased HDL cholesterol, the “good” cholesterol.

The metabolic changes that correlated with treatment with a second-generation antipsychotic drug were of similar magnitude to those observed in younger people with schizophrenia, the team notes.

The results from a previous analysis of the CATIE-AD data indicated that the drugs did not improve patients’ function and quality of life and did not decrease their need for care.

The worsening cardiac and metabolic risks among these Alzheimer’s patients are “particularly concerning,” they add, and likely explain the increased risk of mortality seen with these drugs.