New Medication For The Treatment Of Schizophrenia Significantly Reduces Symptoms And Improves Patients’ Daily Lives(1,2)

INVEGA™ controls symptoms around the clock and may reduce the risk of some drug interactions, which can be a problem in the treatment of schizophrenia

Toronto, ON .- Health Canada has approved INVEGA™ (paliperidone) for the treatment of schizophrenia.1 INVEGA™ is the only once-daily oral treatment for schizophrenia that uses a unique OROS® technology designed to deliver and sustain a controlled level of medication throughout the day.1 Moreover, INVEGA™ is not extensively metabolized in the liver, which may mean fewer drug interactions for patients.1,3

People with schizophrenia are often on more than one medication (called polypharmacy) for conditions including anxiety disorders, depression, cardiovascular disease, diabetes, HIV and hepatitis C.3 In fact, studies have shown that 43 per cent of patients on an atypical antipsychotic are on five or more other medications.4 Taking several drugs along with antipsychotic medication can alter the potency of the medication and may lead to serious and potentially life-threatening adverse events.3 Thus, reducing the risk of drug interactions in the treatment of schizophrenia is an important consideration.

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Cognitive Behavioral Therapy Reduces Risks of Teen Antidepressant Use

The combination of fluoxetine (Prozac) and cognitive behavior therapy for depressed teens may accelerate treatment response and protect against suicidality.

In a randomized trial, combination therapy was not superior to fluoxetine or cognitive behavior therapy after 36 weeks, reported John S. March, M.D., M.P.H., of Duke here, and colleagues, in the October issue of Archives of General Psychiatry.

But a previously published analysis of the same patients, which showed an early advantage in response rate at 12 weeks with combination therapy (73% versus 62% and 48%), suggests that it may be a superior strategy, they said.

"Because accelerating symptom reduction by using medication is an important clinical outcome in psychiatry, as it is in other areas of medicine, use of fluoxetine should be made widely available, not discouraged," they wrote.

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Antidepressant response may predict cardiac event

Among patients who have had a heart attack and subsequently develop depression, a lack of response to antidepressant treatment signals a high risk of another cardiac episode, according to a secondary analysis of data from Myocardial Infarction and Depression-Intervention Trial (MIND-IT).

MIND-IT involved 2,177 patients who were hospitalized with an acute heart attack. During follow-up, 375 patients developed post-heart attack depression. Two hundred nine of these patients were randomly assigned to receive mirtazapine, sold under the trade name Remeron, or to "care as usual."

If there was an inadequate response to mirtazapine after 8 weeks, the patients were switched to citalopram, sold under the trade name Celexa, according to the report in the American Journal of Psychiatry

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Lilly Adds Label Warnings for Mental Illness Drug

Eli Lilly today added strong warnings to the label of Zyprexa, its best-selling medicine for schizophrenia, citing the drug’s tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems.

For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.

Lilly previously argued that Zyprexa had not been proven to cause high blood sugar at a more frequent rate than its competitors.

Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the same period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder Research Program at Emory University.

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Anti-Anxiety Medications For Treating Anxiety Disorders

Everyone suffers a bit of anxiety on occasion. But does that mean you need anti-anxiety medication? Not necessarily.

Your palms begin to sweat and your stomach begins to flutter but you're fine. You're experiencing simple cases of nervousness and your body is responding in ways that are manageable. But, anxiety can explode into a serious problem.

Anxiety disorders, in addition to generalized anxiety, include phobias, panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. For millions of sufferers anxiety disorders are disruptive, debilitating and often the reason for loss of job and serious problems in family relationships. So what can be done to control anxiety disorders?

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Drug firm, subsidiary settle suits for $515m - Pricing schemes, fraud alleged

Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515 million to settle civil suits over fraudulent drug marketing and pricing schemes, including illegally promoting an anti-psychotic drug to children and the elderly, US Attorney Michael J. Sullivan said yesterday.

The settlement between the federal government and Bristol-Myers Squibb and Apothecon Inc. is the third-largest between a pharmaceutical company and the US Attorney's Office in Massachusetts, which has obtained more than $4 billion in healthcare fraud settlements since 2000 and acquired a national reputation for pursuing such cases.

As with many of the earlier settlements, the agreement came after several employees of the pharmaceutical giant turned whistleblowers and filed federal suits in Massachusetts, enticed in part by the track record of federal prosecutors here.

The agreement says Bristol-Myers Squibb gave kickbacks to physicians and healthcare providers from 2000 through mid-2003 to get them to prescribe the company's drugs. The kickbacks came in several forms, including consulting fees and trips to luxury resorts.

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Drug Makers Seek Clues to Side Effects in Genes

Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects.

The new group, the International Serious Adverse Events Consortium, is one of a wave of cooperative research efforts sweeping the drug industry, as companies come under pressure to cut costs and increase their success rates in developing medications. The Food and Drug Administration has encouraged the formation of such groups.

If drugs could be withheld from patients who have a genetic risk for serious side effects, it could not only protect the patients but might help manufacturers get their drugs approved or avoid having to remove them from the market.

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Zyprexa may get OK for teen use - Senior regulator overrules peers on drug's benefits for adolescents

Eli Lilly and Co.'s best-selling schizophrenia drug Zyprexa is poised to get U.S. approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues.
A three-member Food and Drug Administration team initially urged rejecting the drug for pediatric use because of inconsistent data from studies in U.S. and Russian teens. In an April 29 memo posted on the FDA's Web site, Thomas Laughren, head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.
Zyprexa, with $4.4 billion in global sales in 2006, is Lilly's biggest revenue producer and the best-seller among five drugs known as atypical antipsychotics.
The drug's market leadership has slipped because of surging pediatric prescriptions for competing products and side effects linked to Zyprexa. Johnson & Johnson's Risperdal last month became the only drug in the class cleared for pediatric use though doctors long have prescribed the pills to children, according to market research.

READ MORE @ Indianapolis Star

Genes Tied to Bad Reactions to Antidepressant Drug

Variations in two genes may increase the likelihood that a person will report suicidal thoughts after taking an antidepressant, researchers reported yesterday. The finding could help doctors develop tests to predict which patients will do well on such medications and which will react badly.

The authors of the study, which was released to reporters yesterday and will appear in The American Journal of Psychiatry on Monday, said that the findings were preliminary and would need to be verified by further testing.

The study focused on reactions to only one drug, Celexa from Forest Laboratories, and found no link between the gene variations and dangerous behavior like suicide attempts.

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Report Assails F.D.A. Oversight of Clinical Trials

The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.

In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

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Fear Mongering Suicide Statistics to Revive Antidepressant Sales

It's been a busy year for pharma, creating new diseases to make healthy people take pills, reformulating existing drugs to win "new! improved!" patents, hiring high heel wearing reps to intercept the doc before ailing patients--and fear mongering suicide statistics to revive waning antidepressant prescriptions.

Long before the New York Times reported this month that youth suicides were up 8% from 2003 to 2004 and experts blamed an "antidepressant deficiency" big pharma was trying to plant the story.

There's too much money in diagnosing children with major psychiatric illnesses and keeping them on psychotropic drugs their whole lives to let a little thing like the black box warnings the FDA imposed on antidepressants for children in 2004 ruin sales.

READ MORE @ FOOD CONSUMER

Patch could up Alzheimer's medication compliance

The European Commission has on today approved the use of a transdermal patch to deliver medicine to patients with mild-to-moderately severe Alzheimer's disease.

The patch is the first type of transdermal treatment for Alzheimer's disease and is applied once a day to the back, chest or upper arm of patients.

Experts say the patch improves compliance for Alzheimer's patients and also reduces side-effects.

READ MORE @ NURSING IN PRACTICE

A Plan for Better Troop Mental Care

The Department of Defense has released a plan to improve mental-health care for American troops who are facing multiple tours in war zones.

The report lays out a "road map for change" in an effort to "put psychological health and fitness on an equal footing with physical health and fitness." The recommendations address findings from a report released earlier this year that found that troops going to war face increasing levels of anxiety and depression with each successive deployment, with shorter "dwell times," or times at home with their families.

READ MORE @ US NEWS & WORLD REPORT

Use of atypical antidepressants in elderly patients

Late-life major depressive disorder (MDD) is a common disorder that is associated with severe symptoms and substantial functional impairment. With an estimated prevalence of 3% in people aged 60 years or more, MDD has growing health implications for the aging population. In addition, MDD is often associated with physical disability in this age group as well as a high mortality rate. Conditions leading to chronic pain, the presence of comorbid medical illnesses, social isolation, and dysphoria secondary to life-cycle issues predispose the elderly population to the development of depression. These factors also point elderly individuals with depression in the direction of more severe symptoms and a relatively poor outcome.
While it is a commonly known psychiatric disorder, depression in the geriatric population is under-recognized and under-treated, leading to unnecessary impaired social and occupational functioning.1 Studies suggest that approximately 25% of patients aged 65 years or more who have a chronic medical illness also experience symptoms of depression. Evidence supports the increased prevalence of depression in several specific chronic medical illnesses, including vascular disease, diabetes mellitus, and arthritis; the relative risk for depression is 2-3 times higher in these patients than in individuals without these comorbidities.1 Depression in the geriatric population has also been reported to be more somatic and less ideational than depression in younger adults. Elderly people who suffer from comorbid depression and medical illness have an increased morbidity and mortality.1 Authors have also noted a brittle response to antidepressant therapy and an increased risk for chronic depression in the elderly population.2 Safe, effective, well-tolerated antidepressants are needed for elderly patients with MDD, especially for those who are also struggling with chronic medical illness.1

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Risperidone Approved to Treat Schizophrenia in Children

FDA-requested pediatric studies provide valuable clinical evidence on the safety, efficacy, and dosage of antipsychotic drugs in children and adolescents.

The U.S. Food and Drug Administration (FDA) has approved the use of risperidone (Risperdal) in children and adolescents to treat schizophrenia and mania or mixed episodes of bipolar I disorder, making it the first atypical antipsychotic drug approved for either disorder in young patients.

The FDA announced last month that risperidone is approved for the treatment of schizophrenia in adolescents aged 13 to 17 and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17. Risperidone was approved in October 2006 for treating irritability associated with autistic disorders in children and adolescents aged 5 to 16 years.

READ MORE @ PSYCHIATRIC NEWS

Senate approves FDA drug-safety bill

Congress gave final approval Thursday to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous -- a problem linked to an estimated 15,000 deaths a year.

The drug-safety provisions were the centerpiece of a massive bill that also would renew industry user fees that fund the FDA's review of medications and medical devices submitted for approval.

The Senate passed the bill without objection Thursday evening after the House overwhelmingly passed it Wednesday. The White House has not commented on the final version of the bill, but President Bush is expected to sign it, congressional aides said.

In addition to building a new computerized system to spot drug risks, the bill would strengthen the FDA's enforcement powers and require greater disclosure of private and public clinical research and of agency decision-making. It also would take steps to reduce FDA reliance on outside advisors with financial conflicts of interest, as well as create a new program to review drug company advertising.

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Personalised treatment for depression

The 31 million antidepressant prescriptions written annually in the UK could see a marked drop saving the NHS millions, thanks to groundbreaking research recently published by the University of Cambridge’s Brain Mapping Unit.



The study, reported this week in the journal Biological Psychiatry, has found that it may be possible to predict whether patients will respond positively to antidepressant treatment, creating the possibility of tailor-made treatment solutions to the increasingly common condition.

Using magnetic resonance imaging (MRI), a team from the University’s Brain Mapping Unit, led by Prof Ed Bullmore, found that it was possible to forecast the benefits a patient might see from undertaking different types of treatment for depression.

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The ‘Poisonous Cocktail’ of Multiple Drugs

A 78-year-old woman was found unconscious on the floor of her apartment by a neighbor who checked on her. The woman could not remember falling but told doctors that before going to bed she had abdominal pain and nausea and had produced a black stool, after which she had palpitations and felt lightheaded.

Her medical history included high blood pressure, coronary artery disease, atrial fibrillation, congestive heart failure and osteoarthritis. She also had a cold with a productive cough. For each condition, she had been prescribed a different drug, and she was taking a few over-the-counter remedies on her own.

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Are ADHD Medications and Cardiac Risks Linked?

According to a September 17th AHRQ press release, The Agency for Health Research and Quality (AHRQ) together with the Food and Drug Administration (FDA) plan to conduct a huge examination of data from 500,000 patients who are taking medication for Attention Deficit Hyperactivity Disorder (ADHD) to see if the medication increases the risk of cardiovascular problems. The data of both children and adults will be examined, and the study is expected to last two years.

It is already known that medications for ADHD can increase heart rate and blood pressure in patients taking the drug regime, and there have been case study reports of cardiac incidents, according to Dr. Gerald D. Pan, MD of the FDA's Office of Surveillance and Epidemiology, as stated in the AHRQ press release. The study is to determine whether there is a causal relationship between cardiac problems and a person's taking ADHD medications or whether cardiovascular problems are due to the person's already being at risk for the cardiac incidents. The data to be examined is from a preliminary seven FDA year study which ended in 2005.

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It's premature to blame FDA for suicide rise

The front page headline in the Washington Post was alarming: "Youth suicides increased as antidepressant use fell." A new study argued that a record increase in youth suicides in 2004 may have been the unintended consequence of federal warnings that antidepressants such as Prozac can trigger suicidal thoughts in children. Media outlets across the country reported the painful irony that the Food and Drug Administration's attempt to prevent suicides seemed to have increased them by discouraging doctors from properly treating depressed young people.

"We may have inadvertently created a problem," lamented Thomas Insel, director of the National Institute of Mental Health, to the Post earlier this month.

But a closer look at the numbers suggests that the suicide fears are at least premature, if not baseless, say people who specialize in health statistics.

READ MORE @ BOSTON GLOBE