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Zyprexa, also known as olanzapine, is an "atypical antipsychotic drug" used to treat schizophrenia, bipolar disorder, and symptoms of dementia. Zyprexa, as well as other drugs in its class, have become very popular because they do not produce the same "Pakinson's-like" side effects associated with many older medications used to treat schizophrenia and other mental illnesses. Zyprexa, manufactured by Eli Lilly, was approved by the FDA in 1996. Since its introduction, Zyprexa has become Eli Lilly's all time best selling drug, generating over $4 billion in sales in last year alone and accounting for one-third of the company's revenue. However, Zyprexa's blockbuster sales have been overshadowed by reports of serious side effects and deaths.
Zyprexa Studies and Warning Signs. A 2001 report
Journal of Clinical Psychiatry reported that the FDA knew of nineteen cases of diabetes associated with the use of Zyprexa - one of the patients died from pancreatitis associated with diabetes. Another study published in the medical journal Pharmacotherapy in July 2002, suggested a link between Zyprexa and elevated blood sugar disorders and complication, including hyperglycemia, diabetes, and potentially fatal diabetic ketoacidosis and coma.
Researchers reported the 225 were newly diagnosed cases of diabetes among olanzapine (Zyprexa) users studied. One hundred of the Zyprexa patients developed ketosis (a serious complication of diabetes), 22 people developed pancreatitis (inflammation of the pancreas), and 23 of the patient died, including that of a 15-year-old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. The report found that most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain.
British and Japanese governmental health agencies received numerous reports of diabetes and other blood sugar disorders among Zyprexa users, prompting them to issues warnings in 2002.
In April 2003, the Wall Street Journal reported an eight-year study of Zyprexa, in which nearly 300 Zyprexa patients had developed diabetes and twenty-three died. The study found the incidence of diabetes was fifty percent greater in Zyprexa patient than patients taking older antipsychotic drugs. Additionally, reports have revealed that many patients taking Zyprexa have reported dramatic weight gain.
Several comparative drug studies have shown that the incidence of hyperglycemia and diabetes higher among Zyprexa (olanzapine) users when compared against other new "atypical" antipsychotic medications. An August 2003 Pharmacotherapy article cited
that olanzapine (Zyprexa) was associated with a 37% increased risk of development of diabetes compared with risperidone (Risperdal) in the study population, even after adjusting for other risk factors associated with the development of diabetes.
A more recent study, published in the October 2004 American Journal of Psychiatry, compared Zyprexa (olanzapine) with the drug Geodon (
ziprasidone) and discovered that although both drugs were equally effective in the treatment of mental illness, the Zyprexa users studied showed greater weight gain, higher cholesterol and triglyceride levels, and higher insulin levels than patients taking ziprasidone. The Zyprexa patients in the study experienced an average weight gain of 7.9 pounds, while the ziprasidone patients gained an average of 2.1 pounds. Cholesterol and triglyceride levels among the Zyprexa patients increased
whereas cholesterol and triglyceride levels actually decreased among the ziprasidone patients. Furthermore, insulin levels increased 33.7 percent over the treatment period in Zyprexa patients, in contrast to a less-than 3 percent increase in ziprasidone patients. Whereas previous studies have focused on the increased risk of diabetes and other blood sugar related disorders, this recent study also indicates higher cholesterol levels which may play a role in the development of cardiovascular disease.
An October news article by Forbes.com, reports that some doctors are concerned of the rampant off-label use of Zyprexa for treating ailments such as depression, Alzheimer symptoms, and anorexia. Another fact that troubles some doctors is the frequency in which low doses of Zyprexa are prescribed as sleep or calming aids. Dr. George Simpson, who authored a recent study on Zyprexa, stated that its "doubtful that the heavy duty psychiatric drugs are better than over the counter Benadryl for treating insomnia." Additionally, the article cites one of Eli Lilly's own studies, which shows that Zyprexa doubled the risk of stroke when given to elderly dementia patients.
The FDA takes Action - Issues Warning Letter and Label Change. In light of increasing reports of Zyprexa diabetes and other serious blood sugar disorders, the FDA issued a warning in September 2003, asking Zyprexa manufacturer Eli Lily and other "atypical antipsychotic" drug manufacturers to warn doctors that their drugs may increase the risk of diabetes and hyperglycemia, and to place language on the label warning of the possible increased risk of diabetes. The FDA also warned doctors to closely monitor patients taking Zyprexa and other "antipsychotic" medications for abnormal blood sugar levels, especially if patients have a family history of obesity, diabetes, or related conditions.
In March 2004, the FDA published a dear doctor letter, notifying the physicians of important Zyprexa labeling changes.
The letter asks manufacturers of atypical antipsychotic medications, including Eli Lilly, to "add a Warning statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Zyprexa." The letter also states that,
"studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics" such as Zyprexa. Furthermore, the letter states that hyperglycemia,
which can result in ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Zyprexa. Additionally, the letter states that physicians should closely monitor patients for signs of diabetes.
Jan 2005 Update: Zyprexa Linked to Increased Risk of Insulin Resistance and Diabetes
According to a new study conducted by Massachusetts General Hospital, patients taking Zyprexa (olanzapine) and Clorazil (clozapine) had an increased risk of insulin resistance, a major factor in the development of diabetes and other serious health problems. The study supports previous studies linking Zyprexa to diabetes and other blood sugar disorders.
David C. Henderson, M.D., from Massachusetts General Hospital and Harvard Medical School , Boston , and colleagues, evaluated 36 non-obese outpatients with schizophrenia or schizoaffective disorder who were treated with clozapine, olanzapine, or another medication, risperidone. Participants in the study were given a diet to maintain body weight and were told to fast for 12 hours prior to undergoing a frequently sampled intravenous glucose tolerance test. Researchers found that, "Both nonobese clozapine- and olanzapine-treated groups displayed significant insulin resistance and impairment of glucose effectiveness compared with risperidone- treated subjects."
Henderson said he started looking into the problem several years ago after noticing patients were "developing diabetes at rates quite higher than we would expect."
“We've seen reports of patients developing insulin resistance who have been on the drug just a few weeks up to 10 years," he said.
The authors of the study warn: "Psychiatrists and primary care professionals should be aware that patients treated with clozapine and olanzapine may be at increased risk for insulin resistance, even if not obese. Insulin resistance is associated with hyperlipidemia, hypertension, and cardiovascular disease and over time may increase the risk for diabetes mellitus in vulnerable individuals. Patients treated with these agents should be routinely screened, counseled to reduce risk, and provided early interventions."
"Clinicians need to recognize there is a risk and inform patients about it as well as do a risk assessment and monitor for these potential side effects," Henderson said, adding, "If there are other risk factors for diabetes, these aren't the first drugs you go to."
The study is published in the January issue of The Archives of General Psychiatry, one of the Journal of the American Medical Association Archives journals.
April 2005 Update: FDA Orders Black Box Warning Concerning Risk to Elderly Dementia Patients
The FDA ordered manufacturers of several atypical anti pyschotic drugs, including Zyprexa, to add a black box label that warns of a higher death rate among elderly dementia patients taking the drugs, and that
the drugs are not approved to treat symptoms of dementia in the elderly. A black box label is the strongest warning that a drug can carry. An analysis of 17 studies covering four drugs showed the rate of death for the elderly patients taking them was about 1.6 to 1.7 times the rate of death for placebo users. Although there is no official data on the number of dementia patients taking the drugs, the FDA believes that such prescriptions are common.
This website is not medical or legal advice, and patients should consult their doctor about health and treatment questions. Zyprexa has not been recalled.
We are currently investigating another pharmaceutical product concerning alleged diabetic complications. For further information visit TequinDiabetes.com.
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