Posts Tagged ‘Seroquel’

Drugged to Death: Soldiers returning from war are being given deadly cocktails of psychiatric drugs

Tuesday, March 9th, 2010

AlterNet
By Martha Rosenberg
March 9, 2010

Sgt. Eric Layne’s death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was “suffering from incontinence, severe depression [and] continuous headaches,” according to his widow, Janette Layne.

Soon he had tremors. ” … [H]is breathing was labored [and] he had developed sleep apnea,” Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

Read entire article:  http://www.alternet.org/world/145892/are_veterans_being_given_deadly_cocktails_to_treat_ptsd

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Drug maker AstraZeneca facing 26,000 lawsuits over its antipsychotic drug Seroquel causing diabetes

Wednesday, February 3rd, 2010

Bloomberg.com
By Jef Feeley and Margaret Cronin Fisk
February 3, 2010

AstraZeneca Plc is facing as many as 26,000 lawsuits over its antipsychotic drug Seroquel as the drugmaker prepares for its first jury trial over claims the medicine causes diabetes, according to court filings.

Attorneys for AstraZeneca, the U.K.’s second-largest drugmaker, met with plaintiffs’ lawyers in court-ordered mediation sessions last month to discuss a possible settlement of the Seroquel cases, according to court filings. Consumers’ lawyers said they had about 26,000 cases in their inventories, Stephen Saltzburg, a George Washington University Law School professor who served as mediator, said in the filing.

“I wish there were a magic wand that could be waived to settle all Seroquel cases instantly,” Saltzburg said in the filing. “Such wand does not exist.”

AstraZeneca’s stock fell last week after the drugmaker’s sales forecast and stock-buyback plan disappointed some analysts and fourth-quarter profit missed estimates. The company plans to buy back as much as $1 billion of shares this year, officials said Jan. 28.

The company said in a U.S. Securities and Exchange Commission filing last week it faces more than 25,000 claims that Seroquel caused diabetes.

Read entire article:  http://www.bloomberg.com/apps/news?pid=20601087&sid=a6MfYbj9JtRc&pos=7

That’s a 65 percent increase in cases over the number the company reported in a January 2009 regulatory filing. Many of the suits also claim AstraZeneca promoted Seroquel, approved for schizophrenic and bipolar patients, for unapproved uses.

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New allegations of suppressed drug data surface as thousands sue over antipsychotic drug causing weight gain/diabetes

Friday, January 29th, 2010

BBC News
January 26, 2010

The marketing team sued over a drug’s alleged side effects tried to suppress key data, an ex-employee has claimed.

Seroquel’s former UK medical adviser told the BBC he was pressured to approve promotional material which said weight gain was not an issue.

Maker AstraZeneca, which faces fresh legal action next month, said it took concerns about its conduct seriously.

In the same programme, the British Medical Journal editor urged that the medicine licensing system be reviewed.

Dr Fiona Godlee said industry should no longer provide the evaluations of its own drugs which the licensing body considered.

‘Job threat’

Thousands of patients are suing AstraZeneca in US courts, claiming the anti-psychotic drug Seroquel caused weight gain and diabetes.

The patients allege Seroquel, its second biggest selling drug worth $4.5bn (£2.7bn) a year, was marketed without adequate warning about possible side effects such as massive weight gain and the development of diabetes. However, this is denied by the company.

Read entire article:  http://news.bbc.co.uk/2/hi/health/8478924.stm

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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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Pharma Funded FDA’s Christmas Present to Drug Companies: Approving use of deadly antipsychotic drugs for kids

Thursday, December 31st, 2009

Martha Rosenberg
OpEdNews.com
December 30, 2009

You couldn’t get much naughtier than Eli Lilly in 2009 who agreed to pay $1.42 billion for mismarketing Zyprexa and Pfizer who agreed to pay $2.3 billion for Bextra, Geodon, Lyrica and Zyvox fraud.

Pharma will continue to dole out such payouts and consider them a slap on the wrist says a Bloomberg article until prosecutors and judges “use the ultimate sanction, a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.”

Nor did the mismarketing and fraud only enrich drug companies and loot Medicaid and Medicare tax dollars.

Doctor have also cleaned up like Chicago psychiatrist Michael Reinstein who received $500,000 to promote a drug that Medicaid records say he prescribed 41,000 times according to Chicago Tribune and Propublico, figures Reinstein disputes.

And Miami psychiatrist Fernando Mendez-Villamil who wrote 97,000 psychoactive prescriptions for Medicaid patients over 18 months says the Miami Herald –153 prescriptions a day. His prescribathon even drew a letter from Sen. Charles Grassley, ranking member of the Senate Finance Committee.

Read entire article: http://www.opednews.com/articles/-Naughty-Pharma-Still-Got-by-Martha-Rosenberg-091230-724.html

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Big Pharma paid $500,000 to Chicago psychiatrist who used children as guinea pigs

Sunday, December 20th, 2009

E. Huff
NaturalNews.com
December 18, 2009

A federal lawsuit has been filed against pharmaceutical giant AstraZeneca for its role in paying Chicago psychiatrist Dr. Michael Reinstein nearly $500,000 over the course of a decade to conduct research and to promote its anti-psychotic drug, Seroquel. Reinstein is being accused of wrongfully preying on thousands of mentally-ill patients in order to rake in profits for AstraZeneca.

Reinstein has a long history of working with AstraZeneca, receiving regular payments for speeches he would make across the country promoting the drug. AstraZeneca was also paying a for-profit research company, Uptown Research Institute, who in turn was paying Reinstein consulting fees for his services.

Cited in the lawsuit was the fact that Reinstein would continually prescribe roughly double the amount of drugs other psychiatrists would prescribe for the same conditions. When patients would report their pain and suffering due to the tremendous side effects of such drugs and their abnormally high dosages, Reinstein would largely ignore their concerns.

Read entire article: http://www.naturalnews.com/027765_psychiatrists_Seroquel.html

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That British Drug Maker Glaxo’s $1 Billion Paxil Settlements Were Disclosed by Press – Not Drug Maker – Is Cause for Concern

Tuesday, December 15th, 2009

Jim Edwards
BNET
December 15, 2009

British drug company GlaxoSmithKline (GSK) has paid $1 billion to settle lawsuits related to Paxil. The fact that it was disclosed by Bloomberg and not the company itself illustrates how lousy financial disclosure rules are in Europe and why drug companies based there cannot be trusted to tell the truth about what is going on with their litigation liabilities and, by extension, the safety of their drugs.

Bloomberg got the $1 billion number by piecing together litigation records, analysts’ reports and GSK’s own partial statements on the issue. But compare the Paxil situation with those faced by Eli Lilly (LLY) and AstraZeneca (AZN). Both companies have been engaged in litigation that has cost them billions (over the antipsychotics Zyprexa and Seroquel, respectively). And both companies have disclosed the full legal bill attached to those suits. (It’s more than $3.3 billion for Lilly and $1.1 billion for AZ.

Those numbers were disclosed in both companies’ earnings reports. Interestingly, Lilly disclosed them because it was required to report anything “material” by the SEC — it’s an American company and that’s the law. Fines and prosecutions await American firms that fail to report bad news.

Read entire article: http://industry.bnet.com/pharma/10005807/gsks-1b-paxil-problem-highlights-murky-disclosures-from-euro-drug-companies/

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US Kids Represent Psychiatric Drug Goldmine

Monday, December 14th, 2009

Truthout
Evelyn Pringle
December 12, 2009

Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.

On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.

In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.

The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.

Read entire article: http://www.truthout.org/1213091

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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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