from fda.gov -->
MEDICATION GUIDE
SEROQUEL (SER-oh-kwell)
(quetiapine fumarate)
Tablets
What is the most important information I should know about SEROQUEL?
SEROQUEL may cause serious side effects, including
1. Risk of death in the elderly with dementia
2. Risk of suicidal thoughts or actions
3. High blood sugar (hyperglycemia)
4. High fat levels in your blood (increased cholesterol and triglycerides)
5. Weight gain
These serious side effects are described below:
1. Risk of death in the elderly with dementia: Medicines like SEROQUEL can
increase the risk of death in elderly people who have memory loss (dementia).
SEROQUEL is not approved for treating psychosis in the elderly with dementia.
2. Risk of suicidal thoughts or actions (antidepressant medicines,
depression and other serious mental illnesses, and suicidal thoughts
or actions):
Talk to your, or your family member’s, healthcare provider about:
• all risks and benefits of treatment with antidepressant medicines.
• all treatment choices for depression or other serious mental illness.
• Antidepressant medications may increase suicidal thoughts or actions
in some children, teenagers, and young adults within the first few
months of treatment.
• Depression and other serious mental illnesses are the most important
causes of suicidal thoughts and actions. Some people may have a
particularly high risk of having suicidal thoughts or actions. These
include people who have (or have a family history of) depression, bipolar
illness (also called manic-depressive illness), or suicidal thoughts or actions.
• How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
• Pay close attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is very important when an
antidepressant medicine is started or when the dose is changed.
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Seroquel - Manufactured by AstraZeneca and approved by the FDA to treat psychotic conditions such as schizophrenia and psychosis (such as hallucinations) that are sometimes associated with bipolar disorder (manic depression), Seroquel is the company’s second biggest moneymaker, with sales over $3 billion dollars in 2006. There aren’t that many schizophrenics or people with bipolar illness with psychosis to support such widespread use. Most prescriptions for the drug are “off label”– for anxiety and depression. Despite its huge sales,
Seroquel often causes rapid weight gain, and may also have serious adverse effects such as diabetes, hyperglycemia, pancreatitis, and sudden death.
The FDA is considering whether to approve Seroquel for depression and anxiety, and their major question is: do the benefits outweigh the risks? In her testimony at the FDA’s public meeting on this topic on April 8, 2009, NRC president Dr. Diana Zuckerman concluded that the risks are too great, saying “These side effects are considered acceptable for schizophrenia treatment but should not be considered acceptable for depression or anxiety, since there are other, safer alternatives.”
This is especially true since Seroquel’s effectiveness is very modest. The benefits are statistically significant in several studies conducted by AstraZeneca (but not all of them).
In fact, the patients on placebo (“sugar pills” that look just like medication) are improving greatly in these studies – almost as much as those taking Seroquel. Most of the improvement for patients is apparently due to the placebo effect: when depressed or anxious patients take a new pill, they tend to get better, even if the pill has no active ingredients that work. The drug itself appears to add little benefit. The difference between depression scores for patients taking Seroquel is just slightly better than the scores for the patients taking the placebo. These differences are sometimes statistically significant, but that doesn’t mean they are meaningful improvements to the patients. In fact, Seroquel doesn’t have any ingredients that are targeted to reduce depression or anxiety. Instead, patients taking Seroquel tend to feel “knocked out” – they tend to fall asleep. That may improve their scores on an anxiety scale or depression scale (since anxious and depressed people often have trouble sleeping) but it doesn’t mean the patient actually feels less anxious or depressed.
The bad news is that in addition to those modest benefits there are numerous side effects. The Seroquel patients are significantly more likely to drop out of the study because of side effects (such as drowsiness or weight gain) than the placebo patients. Since the studies that AstraZeneca used to prove the safety and effectiveness of Seroquel for depression and anxiety are short-term (6-8 weeks), they cannot realistically measure long-term adverse effects. Patients who take drugs for depression don’t usually stop after 6 weeks or 8 weeks. Many will take drugs for many months or many years. In addition to diabetes and the above-mentioned risks,
patients who take Seroquel are at risk of developing tardive dyskinesia, a condition that causes uncontrolled movements, such as grimacing, tongue protrusion, and lip smacking. There is a lack of effective treatments for these symptoms and stopping the drug after the problems have started usually doesn’t work. The nonprofit organization that educates people about movement disorders such as tardive dyskinesia, is clear about the importance of avoiding drugs that can cause this disorder; they say: “every effort should be made to limit the use of these drugs to those patients for whom no other treatment options are available.” Drugs that can cause tardive dyskinesia should therefore never be given to anyone with depression or anxiety unless every other, safer drug has already been tried and failed.
Again, Seroquel is being widely prescribed for patients who could be treated at least as effectively with safer, less expensive medications.
Consumers need to be their own advocates because even if a prescription drug label warns to try other medications first, many doctors tend to overlook that warning, especially when drug companies spend billions of dollars for advertisements, speeches, medical articles, and personal meetings to “educate” doctors about how effective the drug is.
The most alarming reason AstraZeneca should prohibit the use of Seroquel off label is the danger of sudden death. Although relatively rare, this risk is unacceptable for a drug used to treat depression or anxiety, since safer alternatives are available. At the FDA’s April 2009 public meeting on Seroquel, family members testified about how their loved ones, veterans of the Iraq war, had died after being prescribed Seroquel from the VA for post traumatic stress disorder (PTSD). Commented Harold S. White, who lost his son under questionable circumstances: “In my research, I have found at least 51 military men have died in their sleep in the past six years, 35 in the last three years.” He added that it “was always the same story,” with perfectly healthy people dying suddenly after taking the drug. Cassandra Harper testified that “the doctors and nurses (at Walter Reed) should be given more information on the drugs they prescribe and possible side effects/interactions.”
We don’t know why so many doctors are prescribing drugs like Seroquel, which has dangers that don’t outweigh the risks except when used for schizophrenia and psychosis from bipolar disorder. We know that some physicians are influenced by the drug companies’ heavy advertising and promotional activities, which include paying famous and well-respected physicians to praise these drugs to other doctors. If you are not schizophrenic and don’t have psychosis from bipolar disorder (also called manic-depression), we suggest that you tell your doctor that you want a safer option.
-center4research.org
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Seroquel was passed through with fraudulent research studies : AstraZeneca, the company who manufactures Seroquel has been indicted for misleading doctors and patients with enhanced reports of its effectiveness and covering up its effect of increasing diabetes and pancreas problems. There were implications that the doctors involved in the research studies were not playing by ethical, non-biased rules. They weighted the research to give Seroquel glowing research conclusions. The company's sales staff also was involved in unethical sales promotion or lying to the medical facilities. This is another drug that got through the system for years under fraud and deception. 25,000 lawsuits later and a fine of $520 million and they are still in business.
Seroquel has been around since 1997. When the drug first appeared, its side effects also quickly surfaced: weight gain, muscle tics, drooling, muscle stiffness, and irregular gaits. It was then reformulated in the goal to stop those problems.
The New Seroquel has even worse side effects, which among them in the increased risk of diabetes, tremors, coma, ketoacidosis, weight gain, and death. Seroquel is considered the worst in this class of drugs to increase the risk of diabetes. It is believed to increase the risk of diabetes by three fold. Pancreatitis increase is associated with this drug as well.
Increased Risk of Death: 17 independent studies have shown it increases the death rate in elderly patients who were prescribed the drug for senile dementia. They had increased risk of heart failure and lung infections leading to their death.
Increased Risk of Pancreatitis - Pancreatitis is Inflammation of your pancreas causing symptoms including fever, stomach pain, vomiting, diarrhea, shock, diabetic coma, and ketoacidosis. This drug can lead to long term disability that is permanent even when the drug is withdrawn.
Increased Risk of Diabetic Ketoacidosis - The drug impacts the glucose level in your body impairing its ability to process sugar. Sugar builds up in your bloodstream causing dehydration and sugar starvation which results in coma and death.
Billions Of Profits Made on Your Health: This drug has made the company $4.7 billion a year with $2.9 billion in prescriptions in the U.S. AstraZeneca has raked in $17 billion of profit off sales of Seroquel just since 2004. $520 million in fines is nothing. Does lawsuit money awarded to these patients really cover the loss of a limb due to diabetes? Does it cover the cost to your child from diabetes in lowered quality of health? Does lawsuit money really help when your loved one is dead? Money paid to these patients helps but they are sick the rest of their lives in many cases. Many died a premature death.
www.medicinenet.com/pancreatitis/article.htm
www.nlm.nih.gov/medlineplus/ency/article/000320.htm
http://www.bobgoldwaterattorney-seroquel.com/
www.info.com/topics/seroquel-sideeffects.html
http://www.diabetes.org/diabetes-basics/diabetes-statistics/
http://www.nytimes.com/2010/04/27/business/27drug.html
