Posts Tagged ‘Abilify’

Drugging Kids For Profit: Powerful & dangerous antipsychotic drugs being used on kids more and more often

Monday, January 4th, 2010

Ed Silverman
Portfolio.com
January 4, 2010

If elderly people with dementia are so vulnerable to the risks posed by antipsychotics, why are so many nursing-home residents regularly prescribed the medications?

The answer can be found in a controversy with its roots in aggressive marketing and lackadaisical supervision. Known in the medical community as atypical antipsychotics, this group of drugs was originally approved by the Food and Drug Administration to treat adults suffering from schizophrenia. They go by snazzy names such as Zyprexa, Geodon, Abilify, and Seroquel. Later, regulators allowed doctors to prescribe them for treating bipolar disorder. Over the past decade, the pills have become a veritable goldmine; in 2008 alone, sales in the U.S. reached $14.6 billion.

But critics say those big sales are actually due, in part, to an epidemic of off-label marketing, which is promoting a drug for unapproved uses, although doctors are free to write a prescription regardless. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters. This was particularly troubling, given that the drugs can cause diabetes and weight gain, side effects that prompted thousands of lawsuits claiming that drugmakers tried to hide evidence of these problems.

Read entire article: http://www.portfolio.com/industry-news/health-care/2010/01/04/drugging-kids-for-profit/

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FDA ‘considers’ Antipsychotic drug labels warning of weight gain/diabetes. Considers? Do your job-issue the warnings.

Wednesday, December 9th, 2009

Jennifer Corbett Dooren
The Wall Street Journal
December 8, 2009

WASHINGTON (Dow Jones)–A top Food and Drug Administration official said Tuesday the agency is considering strengthening the labels of antipsychotic drugs to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults.

Thomas Laughren, the director of FDA’s division of psychiatric products, said the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have on metabolic side effects such as increases in blood glucose, which can cause diabetes and blood cholesterol levels which can lead to cardiovascular problems over time.

While the labels of the drugs already discuss weight gain and its associated problems, Laughren said the agency is considering putting all the information in the warnings section, which would amount to a strengthening of the warning.

Laughren made his comments Tuesday at a pediatric advisory committee meeting which was reviewing the safety of several drugs used in children, including antipsychotics.

Laughren said the labels for AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly & Co.’s (LLY) Zyprexa were already changed last week when the agency approved the products for use in younger patients and, in Seroquel’s case, when it was approved as an add-on treatment for major depression. However, he said all of the drug labels in the class could change as the FDA continues its “comprehensive” review.

The drugs are used to treat a variety of mental illnesses, including bipolar disorder, schizophrenia and depression that doesn’t respond to other types of medication.

A study published last month in the Journal of the American Medical Association found the drugs caused children and adolescents to gain an average of 19 pounds in 11 weeks of treatment. The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.

In advance of the pediatric panel meeting, FDA staff recommended the agency should conduct an additional review of antipsychotic drugs to look at the impact of weight gain in children. Several studies have shown children and adolescents gain weight at a faster rate than adults.

Other drugs in the class include Risperdal, made by a unit of Johnson & Johnson (JNJ); Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co.; and Pfizer Inc.’s (PFE) Geodon. Antipsychotics were the top-selling drug class in the U.S. last year, with $14.6 billion in sales, ahead of the $14.5 billion in sales of cholesterol drugs, according to IMS Health.

See article: http://online.wsj.com/article/BT-CO-20091208-714877.html

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With 2 million kids on antipsychotics (extremely powerful/dangerous drugs) FDA finally urges review of use in kids

Friday, December 4th, 2009

AttorneyAtLaw.com
December 4, 2009

The use of powerful antipsychotic drugs like Seroquel and Zyprexa in children should be further studied to determine the risks of metabolic disorders and other serious health complications, Food and Drug Administration staffers say in a new report.

FDA drug reviewers said medical researchers have found a direct link between the use of so-called atypical antipsychotics in younger children and weight gain, high cholesterol, and increased blood pressure, according to a Reuters news report.

Seroquel, Zyprexa and similar antipsychotic drugs are not approved for use in children, but an estimated two million American children are given the drugs by doctors each year to treat a variety of psychiatric disorders. An FDA advisory panel recently recommended approving their use in kids.

The research findings should prompt further FDA evaluation to determine the extent of the risks and possibly take action to limit the use of Zyprexa, Seroquel, and similar drugs in younger age groups, staff in the FDA’s division of pharmacovigilance wrote in an October 14 memo, according to Reuters.

Read entire article: http://www.attorneyatlaw.com/2009/12/fda-staff-urges-more-review-of-seroquel-and-zyprexa-use-in-kids/

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Antipsychotics Like Seroquel Blamed for Deaths and Strokes

Monday, November 16th, 2009

AboutLawsuits.com
November 16, 2009

According to a new report, side effects of antipsychotics, such as Seroquel, Zyprexa, Risperdal and Abilify, could be responsible for as many as 1,800 deaths and 1,620 strokes each year among the elderly with dementia in the United Kingdom.

The report, which was commissioned by the British government, found that the use of antipsychotics for dementia has been largely ineffective, resulting in improvement in only 20% of patients. As a result of the findings, the U.K. Department of Health has initiated plans to reduce the use of atypical antipsychotic drugs like Zyprexa, Risperdal, Abilify and Serquel for dementia in its own health system, and hopes that the reduction will be picked up by other nations as well.

There are an estimated 180,000 elderly people with dementia in the United Kingdom currently being treated with the antipsychotic drugs, according to the report’s author, Professor Sube Banerjee. However, only 36,000 were found to derive any benefit from the drugs.

“The findings of my review confirm that there are indeed significant issues in terms of quality of care and patient safety,” said Banerjee, professor of mental health at King’s College London Institute of Psychiatry, in a letter to the Minister of State that accompanied the report. “These drugs appear to be used too often in dementia and, at their likely level of use, potential benefits are most probably outweighed by their risks overall.”

Read entire article: http://www.aboutlawsuits.com/antipsychotics-for-dementia-blamed-for-deaths-6965/

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Dr. Peter Breggin: Antipsychotic Drugs, Their Harmful Effects, and the Limits of Tort Reform

Monday, November 2nd, 2009

Dr. Peter Breggin
The Huffington Post
October 31, 2009

There are many problems within our legal system that could benefit from reform. But within the area in which I have great experience as a psychiatric expert, so-called tort reform has already gone too far. It is already too difficult for injured patients or their surviving families to bring malpractice suits against physicians and health facilities, and product liability suits against drug companies, even when their cases have great merit. I believe in private health care and I believe in the free market, but liberty requires checks and balances. The right to sue medical practitioners and pharmaceutical companies provides a necessary control in our free market system, as well as a means for individuals to seek compensation and justice.

Harm Caused by Antipsychotic Drugs

For illustrative purposes, I’ll focus on the newer antipsychotic drugs, the so-called atypicals, including Zyprexa, Risperdal, Geodon, Seroquel, and Abilify. These drugs produce horrendous adverse effects that often lead the victims or their surviving families to consider bringing lawsuits against doctors, health care facilities, or drug companies.

First, the antipsychotic drugs produce tardive dyskinesia. Tardive dyskinesia involves drug-induced abnormal movements that commonly disfigure patients and in some cases result in lifelong pain and total disability.

Read entire article: http://www.huffingtonpost.com/dr-peter-breggin/antipsychotic-drugs-their_b_341108.html

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Forbes: New study shows “Hefty Side Effect For Kids On Antipsychotics”

Wednesday, October 28th, 2009

Robert Langreth
Forbes
October 27, 2009

A new study is likely to add to the furious debate over the rapid rise in the prescription of heavy-duty antipsychotic drugs to children. It found that kids’ weight balloons by 10 to 19 pounds in just the first three months on the drugs, often leading to worrisome elevations of cholesterol, triglycerides and other metabolic parameters.

Weight gain is a known side effect of the drugs, but the new study is notable because it found far greater increases than had been seen in many previous trials. Researchers tracked 272 children between the ages of 4 and 19 who started taking various brand-name antipsychotic drugs for the first time between 2001 and 2007. They found weight gains varied by drug but appeared to be widespread across the entire class of medications, called atypical antipsychotic drugs.

“Weight gain was pervasive even in medications usually considered to be weight neutral in adults,” says Albert Einstein College of Medicine psychiatrist Christoph Correll, who led the study, which was conducted at the Zucker Hillside Hospital in Queens, N.Y. “The worry is that weight gain sustained over long periods of time can cause adverse outcomes like diabetes and heart attacks and strokes.”

Read entire article: http://www.forbes.com/2009/10/27/antipsychotics-lilly-astrazeneca-business-healthcare-children.html

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