Zyprexa e Suicidio: Ora potrebbe essere necessario guardare i vostri bambini

Zyprexa Suicide: Now You May Have to Watch Your Children

October 1, 2007

Rockville, MDIn what may be one of the more astounding moves of the year, a U.S. Food and Drug Administration official has overruled his colleagues and will recommend Zyprexa be approved for the treatment of adolescents diagnosed with mental illness. The move comes despite evidence that Zyprexa has been linked to [Suicides], diabetes, weight gain and pancreatitis.
Initially a three-member FDA team recommended Zyprexa be rejected for use in adolescents because they received inconsistent data from studies conducted on teens in the U.S. and Russia. However, Thomas Laughren, who is the head of the FDA's psychiatry division, has overruled that recommendation.

A study, published in the October 2007 edition of [The American Journal of Psychiatry] has found that Zyprexa effectively treated bipolar mania in adolescent patients. However, the study also found that patients treated with Zyprexa, "had significantly greater weight gain and increases in the levels of hepatic enzymes, prolactin, fasting glucose, fasting total cholesterol, and uric acid." Furthermore, the lead author of the study was Maricio Tohen, a professor of psychiatry at Harvard and an Eli Lilly employee.
Participants who took Zyprexa in the study, which occurred over only three weeks, gained an average of eight pounds. That's eight pounds in only three weeks, an incredibly short time to gain that amount of weight. Three weeks is certainly not long enough to determine what the risk of suicide is in adolescents who take Zyprexa.
Zyprexa had $4.4 billion in global sales in 2006 and is Eli Lilly and Co.'s best-selling drug.

READ MORE LEGAL NEWS

• Long-Acting Zyprexa Gets Limited Ok by FDA
• Zyprexa: Eli Lilly could be Tagged with $1 Billion Dollar Fine
• Zyprexa Suicide: Children at Risk

Exactly what effect the potential approval will have on the suicide rate of teens is not known. After all, Lilly has already been in trouble for promoting Zyprexa for off-label uses and although Zyprexa is not currently approved for use in adolescents, many doctors still prescribe if off-label. This is not illegal, but it certainly is questionable in light of the consequences some adults have faced after taking Zyprexa.
Pre-marketing clinical trials showed that Zyprexa had a higher rate of suicide than any other antipsychotic. According to Zyprexa's label, suicide is an infrequent (but not rare) side effect. Infrequent adverse events occur in between 1/100 and 1/1000 patients. Zyprexa is currently approved to treat symptoms of schizophrenia and acute bipolar mania in adults.
Given all the serious side-effects reported in Zyprexa - weight gain, pancreatitis and risk of suicide to name a few - should we really be giving youth this drug without having a better understanding of how it works? Since Zyprexa has been linked to an increased risk of suicide attempts in adults, shouldn't we understand that risk better before we give it to youth?

Zyprexa Suicide Legal Help - Suicidio Zyprexa Aiuto Legale

Zyprexa e Suicidi: Bambini a Rischio

Zyprexa Suicide: Children at Risk

January 15, 2008

Fayetteville, TN

When Sarah D. was only a child she was put on Zyprexa to help control the mood swings associated with her bipolar disorder. Beth (Sarah's mother) says that they tried several drugs, but from around age eight to age fourteen, Sarah took Zyprexa. According to both Beth and Sarah, it was only a matter of months after her prescription began before Sarah started cutting herself.
"When she was on Zyprexa, she exhibited suicidal tendencies," Beth says. "She talked in a very degrading manner about herself and tried cutting herself. It was really strong when she was an adolescent. She would draw pictures of her cutting herself, taking pills, running in front of a car or hanging herself. She even said it would be all she could do not to run in front of a car when she was next to traffic.

"She would cut herself and hide the cuts. I had to hide the knives from her. She never had to be hospitalized—it never got that far. But she would talk about how suicidal she was, so it was still fairly serious.
"Her dad and I could not understand why—she is a beautiful daughter—why all of a sudden she was feeling terrible about herself. Her self-esteem plummeted. She was fixated with cutting herself. And she would use other things, not just knives. Pencils, ink pens, nail cutters...anything. She started having bizarre behaviors like crawling under tables and desks at school. She would dig into the door and furniture and carve things like, 'I hate myself,' or 'I'm gonna kill myself,' or 'die, die, die,' and then cover them with posters. I only found out about that when a poster fell off the door. But they didn't take her off Zyprexa.
"Now, she looks back and realizes that she doesn't know where those behaviors came from."
Sarah (now 16 years old) says that she remembers some of her time on Zyprexa, but not all of it. "I felt depressed a lot of the time," Sarah says. "I didn't like taking it. It made me so bad and I didn't like feeling bad. I had low self-esteem. That has changed since I stopped taking it. My esteem has gone way up. I was happy to stop taking it."
She says that she cut her arms almost every day, but does not know what she was thinking when she did. "My mind was rambling, I don't know what was going through my head. It affected how I thought—I couldn't think straight most of the time I was on it."

READ MORE LEGAL NEWS

• Long-Acting Zyprexa Gets Limited Ok by FDA
• Zyprexa: Eli Lilly could be Tagged with $1 Billion Dollar Fine
• Zyprexa: Suicide can be a Side Effect of Drugs

Both Beth and Sarah agree that Sarah's behavior took a turn for the worse only a few months after she started taking Zyprexa. She has now been off Zyprexa for two years and in that time has stopped cutting herself and no longer experiences suicidal tendencies.
"We want to trust doctors and when they recommend something, we want to listen to what they say," Beth says. "We want to help our children, but that was a nightmare. Zyprexa was a nightmare. You wonder if that suicidal cutting could have been avoided."
Like many other people, Beth wants to see Eli Lilly pay for the harm she believes Zyprexa has caused. "I am going to follow up with this," Beth says. "I'm convinced it was that drug. I don't think she would have acted like that if she hadn't been on Zyprexa."

 

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#Zyprexa #Olanzapina #Suicidio #Bambini #EliLilly 

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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Le Famiglie delle Vittime di Suicidio dovuto a Zyprexa Sono Arrabbiate

Zyprexa Suicide Victims' Families Angry

December 6, 2007

Louisville, KY

The family members of people who committed suicide after taking Zyprexa are understandably upset that they were not made aware of the risks associated with taking the drug. Patients as young as nine years old have reported having suicidal thoughts after taking Zyprexa and some adults have committed suicide.
Now, as more reports of people committing suicide while taking Zyprexa are made public, more family members realize that it may have been the drug, and not their loved one's disorder, that caused them to commit suicide.
One comment that is repeated over and over again by people complaining about the suicide risk in Zyprexa patients is that they were not suicidal before taking the drug. This is reported both by patients who took Zyprexa and the family members who have lost loved ones to suicide. Many people who took Zyprexa and complained about suicidal thoughts say they had never had such thoughts before taking the drug.

As one interview subject pointed out, before taking Zyprexa her life had been going fairly well. She was simply given Zyprexa to help treat bipolar disorder, but suicide had not been something that even entered her mind. However, within weeks of starting the drug, she became suicidal, coming to the point where every day was a struggle not to kill herself. She says that at the time she did not fully understand why she wanted to commit suicide, she just felt that she had to.
It was not until after her ordeal was over that she realized the drug she was taking could have caused her suicide attempts. Luckily, she survived her ordeal but countless others may not have. Their families could still be blaming their loved one's disorders for the suicide without realizing that Zyprexa could have led to their suicide. In fact, the rate of completed suicides linked to Zyprexa is higher than the rate associated with any other atypical antipsychotic, the class of drug that Zyprexa belongs to.
Some patients taking Zyprexa report that they have suicidal thoughts continuously and wake up trying to figure out how to commit suicide. Many have more than one suicide attempt and because their doctors do not realize that the suicide attempt is related to Zyprexa, the patients are given either an increased dosage of Zyprexa or a deadly drug combination that also increases their suicidal ideation.

It is a deadly cycle that rarely ends well for the patient. Those who complain about suicidal thoughts are often not taken seriously because, as patients diagnosed with mental disorders, their opinion is neither credible nor important. Unfortunately, because the medical and pharmaceutical communities are not listening to their concerns, patients are dying and their suicide is being blamed on their mental condition rather than on the drug they were taking.
It is not okay to dismiss someone's death simply because they had bipolar disorder or schizophrenia. Simply assuming that they committed suicide because of their disorder allows pharmaceutical companies to continue marketing their drugs as safe when they may not be. If Zyprexa is responsible for the death of loved ones, then family members have a right to know. Furthermore, future patients have a right to be properly informed of all risks associated with Zyprexa before they decide whether or not to take that particular drug.

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Zyprexa collegato ad Acatisia e Suicidio

Zyprexa's Link to Akathisia and Suicide

November 7, 2007

Seattle, WA

Despite evidence that Zyprexa is linked to an increased risk of suicidality, Eli Lilly is not pulling its drug from the market, arguing that Zyprexa's benefits outweigh any risks. Victims who have attempted suicide and families of patients who committed suicide are now investigating the possibility of a class action lawsuit against Lilly, alleging the company did not properly warn consumers about the risks associated with Zyprexa.
People who have had loved ones commit suicide after taking Zyprexa may assume that the reason they were taking the Zyprexa (for schizophrenia or depression) led to the suicidal act. However, there could be more to the story than that. A link between Zyprexa and akathisia has been documented, meaning that patients who take Zyprexa are at an increased risk of developing akathisia. Akathisia can be a precursor to suicidal thoughts and violence.

Akathisia is a side effect of antipsychotic drugs that is characterized by inner restlessness. Patients with akathisia are unable to sit still, often rocking while standing, fidgeting, crossing and uncrossing their legs and pacing. In mild cases, patients may feel a slight sense of anxiety and restlessness; however, in more severe cases patients are completely unable to remain at all motionless and suffer from severe anxiety and a sense of doom. In some cases, patients with akathisia act out with violence, throwing things, breaking things or harming themselves or other people.
Akathisia is often accompanied by insomnia, anxiety, panic and restlessness. In severe cases, the patient's sense of doom can be so overwhelming that the patient resorts to suicide attempts. Among the symptoms of akathisia are anxiety, tension, impatience, irritability, inner restlessness, and physical discomfort. Patients with akathisia may view death as a welcome relief to what they are experiencing.

READ MORE LEGAL NEWS

• Long-Acting Zyprexa Gets Limited Ok by FDA
• Zyprexa: Eli Lilly could be Tagged with $1 Billion Dollar Fine
• Zyprexa Suicide: Children at Risk

Acute akathisia, which has been linked to antipsychotic medications, can begin in as little as a few hours after starting the medication that causes it. Tardive akathisia begins more slowly, up to three or four months after starting the medication, and can last for years. Unfortunately, akathisia can be difficult to diagnose and many patients are given higher doses of antipsychotic medications to treat the symptoms. Patients with akathisia are also noted to be more non-compliant than patients without akathisia, meaning that they are more likely to discontinue medication or stop seeking medical help.
Patients who have developed akathisia say that it is a terrible ordeal to go through. They note the frustration they feel from having the medical community either misdiagnose their akathisia or simply not believe that they have it and they say that akathisia itself is often more difficult to endure than the symptoms that their medication was initially treating.
People who take Zyprexa are doing so to treat very serious conditions, including schizophrenia. They do not expect that taking Zyprexa could actually cause even more serious conditions, including one that is linked to suicidality. Unfortunately, that is exactly what taking Zyprexa may lead to.

#Zyprexa #Acatisia #Suicidio

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

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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