Zyprexa, Abilify, Risperdal e Seroquel collegati a Rapido Aumento di Peso nei Bambini

Zyprexa, Abilify, Risperdal, and Seroquel Linked to Rapid Weight Gain in Children

October 29, 2009

Washington, DCThe largest study of its kind to show an association between atypical antipsychotics such as Zyprexa, and rapid weight gain and metabolic changes that can lead to diabetes and hypertension was published Wednesday in the Journal of the American Medical Association (JAMA). The study was conducted in 272 children aged between 4 and 19 years. 

Study investigators evaluated the four top selling antipsychotic medications used in the treatment of schizophrenia and bipolar disorder, namely Zyprexa (Eli Lilly & Co); Abilify, (Bristol-Myers Squibb Co and Otsuka Pharmaceutical Co); Risperdal (Johnson & Johnson); and Seroquel ( AstraZeneca PLC).
Of the four atypical antipsychotics, Zyprexa caused the most weight gain over the course of the study – at nearly 19 lbs, a 15 percent increase. Importantly, Zyprexa was also found to significantly raise cholesterol, insulin, triglycerides and blood sugar levels, all of which can lead to the development of diabetes and heart disease.
Children taking Abilify, Risperdal, and Seroquel gained an average of between 10 and 13 pounds over the 11 weeks, and the drugs' impact on metabolic disease indicators varied.
In an article published in the Wall Street Journal (wsj.com), Christoph Correll, the study's lead author and a psychiatrist and scientist at the Feinstein Institute for Medical Research in Manhasset, NY, said, "The weight gain is much larger than we thought. It's massive, and it's the medication that caused it."

 

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#Zyprexa #Abilify #Risperdal #Seroquel #Obesità #Bambini 

#Diabete #Ipetensione #JAMA #WSJ

FDA Aggiornamento, Farmaci Antipsicotici in Gravidanza

FDA Updates Pregnancy Section Labeling for Antipsychotic Drugs

Washington, DC: The FDA has notified healthcare professionals that the pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
Antipsychotic drugs included in this labeling change are Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

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Last updated on Feb-22-2011

#FDA #Zyprexa #Seroquel #Gravidanza

Ancora altre cause per Seroquel, un Avvocato stima che difendere Seroquel potrebbe costare 10 Miliardi ad AstraZeneca

Seroquel Lawsuits Add Up

May 21, 2007

Dover, DE

Over 350 lawsuits were filed in Delaware last month against the maker of Seroquel. That is more than has been filed in the state in the past two years, which began against AstraZeneca Pharmaceuticals after the FDA ordered a change in Seroquel's label, to warn users about an increased risk of diabetes.

One lawyer estimates that defending Seroquel could cost its maker $10 billion. According to one report, there were almost 7,100 Seroquel cases in the federal multidistrict litigation (MDL). Additionally, there are 1,291 Seroquel claims in New Jersey. 

Seroquel lawsuitsIn response to concerns about Seroquel, a study is being conducted in Fort Lauderdale, Florida to determine the safety and usefulness of Seroquel in patients with acute bipolar mania. The study will examine both men and women ages 18-65.

Meanwhile, a study conducted by Medco Health Inc., the biggest prescription benefit manager in the U.S., has found that antipsychotic drug use in children has almost doubled. This includes Seroquel, which is approved to treat schizophrenia and bipolar disorder in adults but not in children.

AstraZeneca Pharmaceuticals L.P., is also in trouble for how it marketed the drug. The company disclosed in its 2006 annual report that the Philadelphia U.S. Attorney's Office is investigating "allegations that the company promoted Seroquel of non-indicated (off-label) uses." A warning letter was sent to AstraZeneca's director of promotional regulatory affairs on November 16, 2006. The letter raised the FDA's concerns that AstraZeneca was minimizing the risks associated with Seroquel in its promotional material.

In addition to diabetes, Seroquel has been linked to pancreatitis, an inflammation of the pancreas, hyperglycemia, and Neuroleptic Malignant Syndrome, a potentially fatal syndrome with symptoms that include irregular heartbeat, fever, and stiff muscles. It may also increase the risk of death in seniors who have dementia-related mental problems, a condition that Seroquel has not been approved to treat.

Seroquel, known generically as quetiapine fumarate, is an atypical anti-psychotic drug used to treat symptoms schizophrenia including delusions, hallucinations, social withdrawal, and thought disorder. The drug has also been prescribed to treat acute bipolar mania, severe anxiety, and agitation. The FDA approved Seroquel in 1997.

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#Seroquel #Diabete #Pancreatiti #SNM #AIVN 

AstraZeneca accusata di minimizzare rischio diabete con Seroquel

AstraZeneca Accused of Downplaying Seroquel 
Diabetes Risk

October 8, 2009

Orlando, FL
Defective product personal injury, together with the alleged attempts by Seroquel manufacturer AstraZeneca to downplay concern over diabetes and weight gain, have combined to foster lawsuits by upwards of 15,000 Seroquel patients.
Now, the order by a federal judge in Orlando to unseal sales call notes made by AstraZeneca representatives paints a vivid picture as to how AstraZeneca employees attempted to mitigate concern over diabetes risk involving Seroquel.
According to a Bloomberg News report that appeared September 23rd in the Wilmington, Delaware News Journal, a saleswoman employed by AstraZeneca told a US doctor that Seroquel did not cause diabetes and downplayed the concern. This, four years after AstraZeneca warned physicians in Japan as to Seroquel's links with the disease.
It was in 2002 that AstraZeneca alerted Japanese physicians after the manufacturer received reports of diabetes-related cases tied to Seroquel, "where causality with the drug could not be ruled out."
Four years later the AstraZeneca sales rep joined a colleague in meeting with a physician who was complaining of "getting a lot of flak" from patients with regard to reports of diabetes risk.
According to the contents of the sales call notes, the AstraZeneca employee assured the doctor "there has been no causative effect" linking Seroquel and diabetes. As a result of that assurance, the doctor "said he would not quit writing" prescriptions for Seroquel "due to this, at this time," the employee reported in her call notes.
In a similar example, another Seroquel representative reported to his superiors at AstraZeneca in 2005 that he had "discussed weight gain associated with atypicals (the class of drug to which Seroquel belongs)" with a doctor. He went on to report in his notes that he assured the doubting physician of a low incidence of weight gain amongst Seroquel users and encouraged the doctor to make Seroquel his "first line choice."

Seroquel Side Effects Pooh-Poohed

Another revelation surfaced earlier when other documents were unsealed. 
According to Bloomberg, AstraZeneca coached its sales force in the art of deflecting questions about weight gain associated with Seroquel. One AstraZeneca manager, in a 2005 voicemail, offered the US sales force information they could employ to "neutralize customer objections to Seroquel's weight and diabetes profile."
According to Bloomberg the potential for diabetes and weight gain had been observed in some clinical trials—thus the concern was known at the time Seroquel was approved in 1997. Evidence suggests that AstraZeneca attempted to downplay that risk. While the manufacturer warned doctors in Japan over the importance of monitoring blood-sugar levels in 2002, that same warning wasn't made to US doctors until two years later.

#AstraZeneca #Seroquel #Rischi #Diabete #CauseLegali

Seroquel di AstraZeneca, 26000 Azioni Legali

#AstraZeneca #Seroquel #Diabete #FDA #CauseLegali 

Seroquel e marketing illegale, accordo raggiunto per 520 Millioni di Dollari

Seroquel illegal marketing case settled for $520 Million

Last updated on Apr-27-2010

Washington, DC: A $520 million settlement has been reached with AstraZeneca and the US Justice Department, which will bring to an end federal investigations into the marketing practices for the company's blockbuster antipsychotic drug Seroquel.
The UK-based pharmaceutical company will also sign a corporate integrity agreement with the US federal government that relates to the marketing of Seroquel for off-label or unapproved indications, the New York Times reports. 
AZ faced accusations of misleading patients and doctors about the effectiveness of the schizophrenia medication, and the associated risk for diabetes in particular. The aggressive marketing practices resulted in the drug being prescribed to treat children and elderly people for unapproved indications. Side effects including death and rapid weight gain in children prompted warnings about using the drug to treat elderly patients with dementia. 
The settlement makes AZ the fourth pharmaceutical company in three years to admit to federal charges of illegal marketing of antipsychotic medications. However, the company still faces a reported 25,000 civil suits brought by patients who allege the company did not adequately disclose the health risks associated with the drug.

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#Seroquel #Quetiapine #Antipsicotici #Neurolettici

AstraZeneca potrebbe affrontare 6000 cause legali per gli effetti collaterali di Seroquel

AstraZeneca Could Face 6,000 Lawsuits over Seroquel Side Effects

December 6, 2009

Orlando, FL: A recent ruling from a U.S. district judge could create approximately 6000 individual trials for British drug maker AstraZeneca, which faces litigation over Seroquel Side Effects.
Anne Conway, the judge overseeing the preliminary proceedings in the federal Seroquel trial, has recommended returning all individual cases related to the antipsychotic medication back to local courts.
"(This decision) will get the litigation moving," said Paul Pennock, a lawyer for former Seroquel users, in an interview with Bloomberg. "The decision will help get a huge group of cases to a state of trial-worthiness."
Seroquel has been linked to serious side effects, incuding increased risk of diabetes, hyperglycemia, neuroleptic malignant syndrome, tardive dyskinesia and uncontrollable movements.
Seroquel reportedly sold $4.45 billion last year, despite the more than 14,000 lawsuits it faces in the US relating to diabetes claims.

Judge Conway has ordered Astra to meet with a mediator to explore settlement options for the wealth of cases the pharmaceutical giant is facing.
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#Seroquel #Quetiapine #Diabete #SNM #DiscinesiaTardiva

Seroquel e diabete; email interne rivelano che AstraZeneca sapeva

Seroquel Data on Diabetes Buried

Unsealed Emails from AstraZeneca Reveal Cover-Up

An internal email from AstraZeneca (AZ) about its controversial a-typical antidepressant Seroquel, marketed as Quietiapine, allegedly shows that the company knew the drug could cause diabetes. According to one of the lawyers on the case, AZ not only deliberately avoided warning physicians about the risk for diabetes connected with the anti-depressant, but also marketed the drug as virtually 'risk free.'
The email, released as part of a court case against the drug maker, and covered in the media last week, allegedly praised the Seroquel project doctor, Lisa Arventis, for minimizing data from a study which showed that the drug caused diabetes, stating "Lisa has done a great 'smoke and mirrors job!'
The message is just one of 102 documents unsealed during the trial. Reportedly, another of these emails, from the company's publications manager written in 1999, reads "The larger issue is how do we face the outside world when they begin to criticize us for suppressing data." Allegedly, he goes on to say that data from 3 drug trials had been "buried." And, in referencing a fourth trial, says, "We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them."
Seroquel is FDA approved for the treatment of schizophrenia, and bipolar disorder, but is also prescribed "off-label" for depression, insomnia, dementia, and ADHD.
March-02-2009: Drug Maker's E-Mail Released in Seroquel Lawsuit 
[NY TIMES: DRUG MAKER'S EMAIL RELEASED IN SEROQUEL LAWSUIT ]

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#Seroquel #Quetiapine #Diabete #ADHD #Depressione #FDA

Seroquel, 17500 Cause Legali per 198 Millioni di Dollari

17,500 Seroquel Suits Settled for $198 Million

London, UK: Astra Zeneca (AZ), the maker of the antipsychotic medication, Seroquel, has settled 17,500 US-based personal injury claims for $198 million. The suits claim illnesses such as diabetes related to the drug, which is used to treat schizophrenia and bipolar disorder. According to a report on Reuters, the average settlement per claim is $11,300. 

These settlements follow on from several thousand claims settled in early August. 

A further 2,900 cases were dismissed. 


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Last updated on Aug-9-2010

#AstraZeneca #Seroquel #Quetiapine #Diabete #CauseLegali #ClassAction

AstraZeneca, Seroquel, 4000 Cause Legali per diabete

AZ Tentatively Settles 4,000 Seroquel Suits

Wilmington, Delaware: AstraZeneca (AZ) has reportedly tentatively settled a further 4,000 lawsuits brought by people who allege the company's antipsychotic medication Seroquel, causes diabetes.

The terms of the settlements will be kept confidential. However, the company recently settled 200 similar suits for $2 million putting the average settlement at $10,000 per case.

AZ was facing more than 10,000 related suits involving some 22,500 plaintiff groups. The company reportedly said it has spent about $688 million defending Seroquel-related cases to date.


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Last updated on Aug-4-2010

#AstraZeneca #Seroquel #Quetiapine #Diabete #CauseLegali #ClassAction

AstraZeneca, Seroquel Cause Legali

AstraZeneca Settles More Seroquel Suits

London, UK: AstraZeneca, the maker of antipsychotic drug Seroquel, has agreed to pay $150 million to settle more lawsuits that allege the drug causes diabetes.

This latest settlement should conclude some 6,000 lawsuits, each of which will reportedly be settled for roughly $25,000 a piece.

According to a report on Bloomberg, this court-ordered settlement leaves AstraZeneca facing about 4,000 outstanding Seroquel claims. Last summer the UK-based pharmaceutical company said it had resolved about two-thirds of the 26,000 suits over the drug that had been filed in courts around the U.S.


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Last updated on Feb-17-2011

#AstraZeneca #Seroquel #Quetiapine #CauseLegali #ClassAction

AstraZeneca, Seroquel collegato a diabete, Class Action

Seroquel

September-2-2003

A class action lawsuit has been filed against AstraZeneca PLC on behalf of all patients who have used the anti-psychotic drug Seroquel. The suit was filed in regards to a study which was recently released and linked the use of Seroquel to an unacceptable rate of diabetes onset. The suit alleges that the company was aware that use of Seroquel could cause a high occurrence of diabetes; however they failed to adequately warn doctors or patients in the United States. The suit further claims that although the versions of Seroquel sold in Japan are accompanied with a warning label, this safer, more accurate and comprehensive label has not been used in the US. The suit also alleges that AstraZeneca engaged in marketing and promoting Seroquel for off label use that was beyond its FDA approved indications.

If you feel you qualify for damages or remedies that might be awarded in this class action please fill in the form to the right to submit your complaint.

#AstraZeneca #Seroquel #ClassAction #CauseLegali #FDA

AstraZeneca, Seroquel antipsicotico causa diabete

AZ Settles 200 Seroquel Suits for $2 Million

New York, NY: AstraZeneca, makers of the antipsychotic medication Seroquel, have agreed to pay $2 million to settle over 200 cases alleging the medicine causes diabetes. The settlement could mean an average payment per case of $10,000. 

The settlement is the result of a US-court ordered mediation involving some 26,000 cases filed in the UK against the London-based pharmaceutical company.

AZ won the first Seroquel lawsuit to go to trial, when a jury in New Jersey ruled that the company had properly warned the patient's doctor about the risk for diabetes associated with the drug. And a further three Seroquel cases have been thrown out because the plaintiffs were unable to provide enough credible evidence to support their claims of Seroquel-generated diabetes. 

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Last updated on Jul-23-2010
#AstraZeneca #Seroquel #Quetiapine #Diabete #CauseLegali #ClassAction

Zyprexa, Abilify, Risperdal, Seroquel, Causano Rapido Aumento di Peso nei Bambini

#Zyprexa #Abilify #Risperdal #Seroquel #AumentoDiPeso #Obesità #Bambini #Antipsicotici #Schizofrenia
#DisturboBipolare #JAMA #AMA #Drugs #Colesterolo #Insulina #Trigliceridi #Diabete

Seroquel, Cause Legali, Effetti Collaterali, Problemi di Peso e Obesità, AstraZeneca, Diabete, Farmaci, Frode

Ancora cause legali per Seroquel e AstraZeneca. Seroquel ed effetti collaterali. Seroquel e diabete.
#Seroquel #AstraZeneca #CauseLegali #diabete #AumentoDiPeso #Iperglicemia
#DiscinesiaTardiva #SindromeNeuroletticaMaligna

Seroquel, AstraZeneca, Cause Legali, Diabete, FDA, Effetti Collaterali, Marketing Illegale, Psichiatri, Rischio Diabete

Seroquel e AstraZeneca ancora cause legali. Seroquel può causare diabete.
Marketing illegale per Seroquel raggiunto accordo da 520 milioni di dollari.
#Seroquel, #AstraZeneca, #Settle, #Suits, #Diabetes, #FDA, #SideEffects, #IllegalMarketing,
#Psychiatrist, #DiabetesRisk

Sentenza contro Johnson & Johnson, sentenza contro Janssen.
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