Anti-aggression treatments like Haloperidol and Risperidone found to be less effective than placebo

New research shows that drugs commonly used to treat aggressive or violent behavior in intellectually disabled patients are about 14 percent less effective than a placebo. The findings come as a surprise to some in the medical field, since antipsychotic drugs like Haloperidol and Risperidone are routinely used to treat aggression.

The study by experts in Great Britain and Australia found a 79 percent reduction in aggressive behavior in patients taking the placebo, compared to a 65 percent reduction in patients taking the antipsychotic drugs Haloperidol and Risperidone. The findings, researchers said, would most likely apply to all similar medications as well.

Lead author Peter Tyrer noted that while all treatments led to a reduction in aggressive behavior after four weeks, patients taking a placebo saw the greatest decrease.

“Our trial has shown that aggressive challenging behavior in people with intellectual disability decreases whether or not active medication is given,” Tyrer said.

While some may be surprised by the conclusion, Dr. David Harley from the Queensland Centre for Intellectual and Developmental Disability said the findings did not seem unusual to him because antipsychotic drugs like Haloperidol and Risperidone have not been used for the reasons they were created.

“They are being used to treat [aggression] which is not a recognized medical diagnosis,” he said. “We might expect drugs like this to work if the aggression was caused by schizophrenia or psychotic illness.”

Other doctors, like Philip Mitchell, head of the school of psychiatry at the University of NSW, said the study should be a wake-up call to psychiatrists of the limited benefit of drugs like Haloperidol and Risperidone.

“It should hopefully make clinicians and doctors more circumspect about their prescribing practices,” Mitchell said.

Source: Bellinda Kontominas, “Drugs used to treat aggression not working,”Sydney Morning Herald, January 5, 2008.

FDA Approves Antipsychotic Drug Risperdal to Treat Schizophrenia, Bipolar Disorder in Children

Decision marks Risperdal as the first drug approved for treating schizophrenia and bipolar disorder in youths

On August 22, 2007 the U.S. Food and Drug Administration (FDA) approved use of the antipsychotic drug Risperdal to treat schizophrenia and bipolar disorder in youths of various ages.

The approval comes with various usage restrictions. Risperdal may be used to treat schizophrenia in individuals ages 13-17 for short-term treatment of manic disorder. Individuals ages 10-17 can be treated for bipolar I disorder with Risperdal. Bipolar I disorder is characterized by recurrent bouts of mania and depression.

The approval marks the first FDA-approved atypical antipsychotic drug to treat the disorders in these age groups. Adults suffering from schizophrenia and bipolar disorder may already be treated with Risperdal.

Thomas Laughren, MD, director of the psychiatric products division at the FDA’s center of Drug Evaluation and Research, says that test data from the trial “suggest[s] a signal for some weight gain” in youths taking Risperdal.

In October of 2006, the National Autism Association (NAA) challenged the FDA’s approval of Risperdal to treat autistic children aged five to 16 due to potential side effects. The NAA warned parents of Risperdal’s side effects, which may include lactation in boys and girls, weight gain, and the development of tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements.

Source: “FDA OKs Risperdal for Kids and Teens”, WedMD.Com, August 22, 2007; Group urges caution on new Risperdal use,” Houston Chronicle, October 20, 2006.

Risperdal maker accused of deceptive marketing

A whistle-blower lawsuit has been filed against drug manufacturer Janssen Pharmaceutica, alleging that the company misled Texas officials about its antipsychotic drug Risperdal in order to maximize profits. Unsealed documents in the Risperdal lawsuit claim that Janssen, a subsidiary of Johnson & Johnson, used deceptive marketing practices that caused Texas to overspend on Risperdal last year at the risk of mental-health patients.

The lawsuit is just one of several currently filed in several states against makers of antipsychotic drugs which accuse drug companies of engaging in deceptive marketing practices by overstating effectiveness while understating risks. Some lawsuits also claim that drug companies have promoted the drugs for unapproved or “off-label” uses.

The Texas lawsuit focuses on the state’s prescription drug program guidelines, which require doctors to give priority to newer drugs in the state-funded treatment of mental-health patients. This program, known as the Texas Medication Algorithm Project (TMAP), began in 1996 with the premise of standardizing prescription of medication to state mental patients. However, the whistle-blowing complaint alleges the Texas health department received as much as $6 million in contributions from Janssen and other parties to implement TMAP guidelines and increase profits of antipsychotic drugs.

According to the lawsuit, after the guidelines were adopted, Janssen “experienced a significant increase of sales of Risperdal” in Texas. Janssen successfully worked with other states to adopt similar programs, including Pennsylvania.

The whistle-blowing complaint was initiated in 2004 by Alan Jones, a former investigator for Pennsylvania’s Office of the Inspector General, who was fired after questioning the system of drug guidelines in Pennsylvania and divulging information about his investigation without permission.

Since the inception of the program in Texas and other states, Risperdal has become the most commonly prescribed antipsychotic medication in the United States, with domestic sales totaling $10 billion from 2001 to 2005, according to IMS Health Inc.

The whistle-blower lawsuit comes as Janssen is preparing to market a new antipsychotic drug: Invega Extended-Release Tablets, the first schizophrenia prescription treatment approved by the FDA since 2003. Invega, which is derived from Risperdal, was approved by the FDA on December 20, 2006.

Sources: Rob Waters, “Suit: Janssen Pharmaceutica misled Texas officials on drug,” Bloomberg News, December 29, 2006, accessed January 4, 2007; Miranda Hitti, “Invega Extended-Release Tablets Include a Newly Approved Chemical,” WebMD Medical News, December 20, 2006,accessed January 4, 2007.

JAMA study finds Zyprexa, Risperdal, Seroquel and Ability may boost death rates in elderly patients with dementia

A new study published in the October 19, 2005, edition of the Journal of the American Medical Association found that Zyprexa, Risperdal, Seroquel and Abilify, drugs used to treat schizophrenia, may raise the death rates in elderly patients treated with the drugs for dementia. These drugs are produced by some of the biggest drug companies in the world, including Eli Lilly and Company (Zyprexa), Janssen Pharmaceutical (Risperdal), AstraZeneca Pharmaceuticals (Seroquel), and Bristol-Myers Squibb and Otsuka America Pharmaceuticals (Abilify).

An analysis of 15 separate drug studies and more than 5,000 patients found that 3.5% of those getting these drugs for eight to twelve weeks died, compared with 2.3% of patients on placebos. The findings come on the heels of risks first disclosed by the FDA in April concerning these drugs.

Lead researcher Lon Schneider, professor of psychiatry at the University of Southern California’s Keck School of Medicine, said that doctors may want to take elderly patients off of these drugs more quickly if they fail to immediately benefit from these drugs, given these findings.

Source: Michelle Fay Cortez, “Lilly, J&J, AstraZeneca Dementia Drugs Boost Deaths in Study,” Bloomberg.com, October 18, 2005.

Group objects to Risperdal use for children

National Autism Association says drug has too many potential side effects

The National Autism Association (NAA) is challenging the Food and Drug Administration’s (FDA) approval of Risperdal as a treatment for autistic children because of the potential side effects of the drug.

Risperdal, made by Johnson & Johnson subsidiary Jannsen, has been on the market since 1993 to treat schizophrenia and bipolar disorder in adults, and was expanded in October 2006 to treat irritability associated with autism in children.

The NAA is urging parents to carefully research the drug and its side effects, which may include lactation in boys and girls, weight gain and the development of tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements.

Johnson & Johnson has stated that the drug was given expanded approval only to treat the irritability symptoms of autism in children.

Sources: “Group urges caution on new Risperdal use,” Houston Chronicle, October 20, 2006; Food and Drug Administration patient information sheet.

Risperdal, Seroquel not worth risk

Alzheimer’s drugs no more effective than placebos and put patients at risk of serious side effects

Researchers reported that three drugs commonly used to calm agitation and aggression in Alzheimer’s patients are not more effective than placebos and put patients at risk for serious side effects, including Parkinson’s disease-like symptoms. This is the third report in the last year to conclude that atypical antipsychotics are not as effective or as safe as originally thought.

The three drugs tested in the study - Zyprexa, marketed by Eli Lilly; Seroquel, marketed by AstraZeneca; and Risperdal, marketed by Janssen Pharmaceutical - are known as atypical antipsychotics and are primarily used to treat schizophrenia. They are often prescribed for elderly patients in long-term care facilities.

Overall, the report found the adverse effects of the three drugs outweighed the benefits, with up to a quarter of the patients in the study dropping out because of the effects.

Some of the side effects observed include:

• Parkinson’s disease-like symptoms, including tremors (12 percent)
• Sedation (15-24 percent of the patients)
• Confusion (6 percent of the patients)

Risperdal, Zyprexa and Seroquel were not approved by the Food and Drug Administration (FDA) for use in Alzheimer’s patients. About 4.5 million Americans suffer from the progressive dementia of Alzheimer’s disease, with most exhibiting agitation or delusions at some point. Almost one-third of the 2.5 million Medicare beneficiaries in nursing homes in the US have taken the medications, accounting for an estimated $2 billion in the annual sales of the drugs.

“The question is whether these drugs have a place in the treatment of Alzheimer’s patients at all,” Dr. Jason Karlawish, an associate professor of medicine at the University of Pennsylvania, said. “I think the answer is yes, but only for a subgroup of patients who can tolerate them, and in facilities that have the expertise to manage the side effects.”

The drugs are required by the FDA to have a black-box warning on the prescription drug insert that states, “elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.”

Researchers in the study followed 421 Alzheimer’s patients who suffer from agitation, delusions or hallucinations. After 12 weeks, there were no signs of significant improvement. About 80 percent stopped taking the drugs and the placebos alike before the end of the study, and those on the drugs were found more likely to quit because of side effects.

“What this study shows is that these drugs are clearly not the answer; they may be helpful for a minority of patients but we need to come up with better medications,” Dr. Thomas R. Insel, director of the National Institute of Mental Health, which financed the study, said.

Sources: Benedict Carey, “Alzheimer’s drugs offer no help, study finds,” New York Times, October 12, 2006; Neil Osterweil, “Atypical Antipsychotics Get Poor Grade for Alzheimer’s Psychoses,” MedPageToday, October 11, 2006.

Risperdal OKed to treat autism

Risperdal approved to treat aggression, other symptoms of autism in children

Risperdal, a Johnson & Johnson drug, received expanded federal approval from the Food and Drug Administration October 6, 2006 to treat aggression and other symptoms of autism in children.

The drug is intended to treat irritability associated with autism, and may help with temper tantrums, deliberate self-injury and aggression in children and adolescents aged five to 16.

Risperdal, while not a cure for autism nor a treatment for the condition itself, is the first approved drug to treat behaviors associated with autism in children and may provide relief for some children.

Two eight-week trials showed that children who received Risperdal achieved significantly improved scores for certain behavioral symptoms of autism.

The drug was first approved by the FDA in 1993 to treat schizophrenia and bipolar disorder in adults.

Autism, a complex developmental disability, affects communication and social interaction, and usually appears during a child’s first three years of life.

Source: “FDA OKs drug to treat autism symptoms,” Chicago Tribune, October 6, 2006.

Anti-Psychotics Linked to High Death Rate in Elderly

Health Canada warns that Risperdal, Zyprexa and Seroquel are linked to 1.6 times higher death rate in elderly patients with dementia

Health Canada, the Canadian regulatory agency similar to the Food and Drug Administration in the United States, has issued a request to manufacturers of certain atypical anti-psychotic medications to include a warning in certain medication labeling for elderly patients with dementia. Recent studies of these types of drugs, which are second-generation anti-psychotic medications usually prescribed for schizophrenia, have shown that elderly patients with dementia had a 1.6 time higher death rate that other elderly patients when taking the drugs Seroquel, Zyprexa, and Risperdal. While no studies were done with the anti-psychotic drug Clozaril, a similar drug, Health Canada has requested that Clozaril labeling also contain a warning.

Seroquel, Zyprexa and Clozaril are not approved in Canada for treating patients with dementia but are approved for use with schizophrenic patients. Prescribing a drug for uses other than its approved indication, a practice known as “off-label” prescribing in the U.S., may cause harm to patients.

Sources: Anne Winstanley, Toronto 680 News, June 15, 2005; Canadian Press, June 16, 2005.

Risperdal not approved for Alzheimers

FDA issues “not approvable” letter to Johnson & Johnson; Risperdal cannot be marketed as a treatment for psychosis in Alzheimer’s patients

Johnson & Johnson announced to shareholders today that it had received a “not approvable” letter from the U.S. Food and Drug Administration denying its request to market its schizophrenia drug [Risperdal}(/companies/janssen-pharmaceutica/risperdal.php) as a treatment for psychosis in Alzheimer’s patients.

[Risperdal}(/companies/janssen-pharmaceutica/risperdal.php) competes with Eli Lilly’s Zyprexa, AstraZenaca Plc’s Seroquel, Pfizer Inc.’s Geodon and Bristol-Meyers Squibb Co.’s Abilify. To boost market share, companies seek to win approval for additional indications for their drugs. [Risperdal}(/companies/janssen-pharmaceutica/risperdal.php) is approved as a treatment for bipolar disorder, or manic depression, as well as schizophrenia. Any indication of a drug for a use not approved by the US FDA is considered an “off-label” use.

Source: “FDA Won’t OK Risperdal,” Reuters.com, May 26, 2005.