Yourlawyer.com (Diabetes News)

FDA orders AstraZeneca to change promotions on Seroquel

Tue, 28 Nov 2006 00:00:00 -0800

AstraZeneca Plc. said today it is cooperating with the Food and Drug Administration to address the agency's concern about marketing material the company distributed to physicians regarding Seroquel, its drug for treating schizophrenia and bi-polar disorder.

The FDA's Division of Drug Marketing, Advertising and Communications, in a Nov. 16 letter to AstraZeneca, said the material is "false and misleading" because it minimized the risk of diabetes and did not adequately communicate the risk of neuroleptic malignant syndrome and tardive dyskinesia, a pair of serious muscular conditions.

"We take the letter seriously," said Jim Minnick, an AstraZeneca spokesman. "The safety of the patients who use our medications is our highest priority. We are currently working with the FDA to resolve the matter."

The marketing piece in question is a fact sheet about Seroquel distributed to doctors along with the drug's FDA-approved product label, Minnick said. The company has until Thursday to respond to the FDA's letter.

Seroquel is AstraZeneca's second-biggest selling product with worldwide sales of $2.76 billion in 2005.

AstraZeneca Warned by FDA About Misleading Seroquel Marketing Material

Tue, 28 Nov 2006 00:00:00 -0800

The U.S. Food and Drug Administration has sent a warning letter to drug maker AstraZeneca, claiming that some of the company’s promotional material for Seroquel contains “false or misleading” information. According to the FDA, AstraZeneca failed to adequately detail the risks of hyperglycemia and diabetes and omitted important data about neuroleptic malignant syndrome and other relevant conditions. Seroquel, an atypical antipsychotic that is used in the treatment of bipolar disorder and schizophrenia, earned roughly $2.76 billion in worldwide sales in 2005.

The FDA sent its warning letter on November 16 to James Gaskill, AstraZeneca’s director of promotional regulatory affairs. The letter held the company in violation of the Federal Food, Drug, and Cosmetic Act because of a misleading promotional sales aid for Seroquel. The promotional material does not include significant data from the product’s required patient-information labeling. According to the FDA’s letter, “The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel.”

The FDA is asking AstraZeneca to refrain from circulating the misleading materials. The company has until the end of the month to respond to the warning letter, but has announced its intentions to work with the FDA to resolve the matter.

Epidemic of Obesity Threatens More than U.S. Children's Waisteline, It Doubles the Risk of Diabetes

Tue, 07 Mar 2006 00:00:00 -0800

The combination of fast-food loaded with fat and calories, massive portions that bear no relationship to daily nutritional requirements, and the lack of physical activity have pushed the percentage of U.S. children who are obese (or almost obese) to around 50%.

If the only problem created by this epidemic of obesity was finding clothing that fits, medical experts would not be concerned. Unfortunately, the dangers faced by seriously overweight children are very real and quite alarming. These include:

•    increased risk of developing serious diseases of the cardiovascular, respiratory, circulatory, and nervous systems;
•    elevated blood pressure and cholesterol levels;
•    long-term damage to the eyes, kidneys, heart, and weight-bearing joints;
•    development of eating disorders; and
•    psychological problems including depression, lack of confidence, and low self-esteem.

Recent studies published in Diabetes Care only provided more evidence of the seriousness of the problem. The findings show that obese children are more than twice as likely to have diabetes as children who are not overweight. Moreover, if they do not already have the disease, obesity is a major risk factor that increases their chances of developing it before adulthood.

After analyzing data from a national survey of over 102,000 children and 1,740 eighth-graders from 12 schools, the combined findings showed what one study author described as a situation that “really screams for us to do comprehensive prevention.”

Although a small number of the children actually had diabetes already, the findings were troubling in that:

•    50% of the 1,740 eighth graders were overweight or close to becoming overweight;
•    children as young as 13 already may have risk factors for type 2 diabetes, which has traditionally been a disease associated with older
      adults;
•    41% of the 1,740 children had elevated fasting blood sugar levels;
•    36% had high levels of insulin (an indicator that the body is developing insulin resistance);
•    Hispanic and Native American childen (already known to have a high rate of type 2 diabetes) had the highest fasting blood sugar levels;
•    obese children are more than twice as likely to have diabetes as normal-weighted children

These findings concern the study authors, especially in light of the nationwide shortage of specialists who care for children with diabetes.

Now, in addition to the fact that half of U.S. children are significantly overweight or obese (and prone to the health problems discussed above), comes the troubling announcement that the problem is a global one and even a conservative estimate places the potential number of obese children in the European Union (EU) by 2010 at some 26 million.

Of that figure, approximately 20,000 will have type 2 diabetes, which had always been known as a disease affecting adults.

The analysis done by the International Obesity Task Force (IOTF) considered global trends with respect to childhood obesity and concluded that even a conservative estimate would be that almost 50% of all children in North and South America could be overweight by 2010.

By 2010, childhood obesity could reach 10% in Europe, 11.5% in the Middle East, 15.2% in North and Sout America, 25% in China, and 5.3% in Asia. Not enough data was available to make any estimate with respect to Africa.

Industrialized countries as well as several “lower-income” countries are showing the same alarming trends since improper diet and inactivity are bad habits that have little to do with national borders.

Study reveals risk to Tequin patients

Thu, 02 Mar 2006 00:00:00 -0800

Six years and 20 million patients later, a popular antibiotic has been found to cause life-threatening changes in blood glucose, according to a study.

Scientists at the Sunnybrook and Women's Science Center in Toronto have studied more than 1,260 patients hospitalized for complications from blood glucose who had received an antibiotic in the 30 days preceding their admission. They looked back to see who among them had received Tequin, the antibiotic in question. Tequin (gatifloxacin), developed by Bristol-Myers Squibb, was federally approved in 1999. About 5,000 prescriptions of the antibiotic are written each day for a variety of bacterial infections. Early on, the company reported some risk for blood-sugar problems, but it was always associated with a history of diabetes and it was not known how common the problem is.

That's why Dr. David Juurlink, a clinical pharmacologist at Sunnybrook and co-author of the study, decided to do a large controlled study to see whether patients taking Tequin were at greater risk of developing this potentially fatal side effect. And the findings, he said, were alarming.

"The problem took several years to appreciate," Juurlink said. After studying 788 patients admitted for complications from low blood sugar and 470 with high blood sugar, all of whom had been given an antibiotic before their hospitalization, the blood sugar changes seemed unique to Tequin. About 1 percent of the patients taking the antibiotic are at risk, "and it's unpredictable who will develop this complication." They found it in patients with and without diabetes.

The hospitalized patients were also compared to an age-matched sample of people who had been on a recent trial of antibiotics, but who suffered no changes in blood glucose. The results, that people on the drug were four times more likely to develop low blood pressure and 17 times more likely to develop high blood pressure than those on other antibiotics - is cause for concern, Juurlink said. The study, to be published later this month in the New England Journal of Medicine, was released early because of the seriousness of the findings.

"One percent is a significant risk, especially when 5,000 patients a day are taking this medicine," Juurlink said. "That's 50 patients a day, and that's only the ones we know about who were hospitalized."

Last month, the company alerted the Food and Drug Administration of the potential side effects, and sent letters to physicians worldwide, according to company spokesman Eric Miller. The company updated the labeling to include a warning of blood sugar changes in certain risk groups, including diabetics, older people and those with kidney problems.

Antibiotic Found to Cause Blood-Sugar Ailments in Seniors

Thu, 02 Mar 2006 00:00:00 -0800

Elderly patients taking the widely used antibiotic gatifloxacin were almost 17 times as likely to be hospitalized for very high blood sugar levels and four times as likely to be hospitalized for unusually low levels, a finding that is leading some physicians to call for the drug's withdrawal from the market.

Overall, one of every 100 patients who took the drug was hospitalized, according to a study released online Wednesday by the New England Journal of Medicine. The study was released before its March 30 publication because of its health implications.

Several previous studies have shown an increased risk of glucose abnormalities and several deaths in diabetic patients who received the antibiotic, trade-named Tequin. The drug's label was changed last month to say it should not be given to diabetics.

The latest study, which is larger and more definitive, showed that all patients were at risk, even those who were not diabetic.

The study's authors said that because other antibiotics were as effective, there was no reason to continue prescribing gatifloxacin.

"Speaking as a clinician, I would never prescribe this drug," said Dr. David N. Juurlink of the Institute for Clinical and Evaluative Sciences in Toronto, who led the study.

Dr. Sidney Wolfe of the Public Citizen Health Research Group in Washington, D.C., said: "This represents a unique danger in the absence of a unique benefit…. This is more than enough reason to think about petitioning the Food and Drug Administration to ban the drug, and we probably will."

Eric Miller, a spokesman for Bristol-Myers Squibb Co., which makes Tequin, said that the findings "were consistent with the post-marketing experience we have had to date." He said the labeling changes in February took the findings into account.

Miller said the company's annual sales of the drug were about $100 million in the United States and $150 million worldwide — a relatively minor portion of Bristol-Myers' $19.4 billion in total revenue.

Gatifloxacin is a member of the family of broad-spectrum antibiotics known as fluoroquinolones. It is typically used to treat gonorrhea and lung, sinus and urinary tract infections. Physicians often use it when the nature of an infection is unknown, Juurlink said, because it kills a wide variety of bacteria.

But the quinoline family has proved problematic. Four other fluoroquinolones have been withdrawn from the market or had their use severely restricted: temafloxacin, for causing red blood cell damage, kidney failure and hypoglycemia; grepafloxacin and sparfloxacin because of heart problems; and trovafloxacin because of liver damage.

"That is an alarming proportion of drugs in that class that have been taken off the market," said Wolfe of Public Citizen.

Gatifloxacin was introduced in 1999. By 2001, 3.3 million prescriptions per year were being written.

Researchers began noticing health problems that year, particularly alterations in glucose metabolism. Changes in blood sugar levels can induce coma and other serious problems, including death. Symptoms usually began five to 10 days after patients took the drug.

In most cases, the symptoms could be reversed when drug use was halted.

By 2003, 17 deaths had been linked to the drug and prescriptions were down to about 1.7 million per year.

One major contributor to that number is the Department of Veterans Affairs, which added the drug to its formulary and designated it an antibiotic of first choice, in part because Bristol-Myers offered the government a price of $1.35 per pill, compared with the $8 to $10 per pill charged for it and other fluoroquinolones at pharmacies, said Dr. Richard Frothingham of Duke University.

The government also chose it because the risk of glucose abnormalities caused by gatifloxacin did not seem to be any higher than that caused by other antibiotics in the class, Juurlink said.

In light of the new findings, he said, "the VA needs to very promptly revisit their policy."

The Canadian researchers studied health records for 1.4 million Ontario residents over age 65. Among them were about 17,000 gatifloxacin patients.

Juurlink and his colleagues then looked at all patients who had been hospitalized after taking an antibiotic. They found 788 were hospitalized for excessively low blood sugar within 30 days of taking an antibiotic and 470 patients hospitalized for excessively high blood sugar.

Within that group, there were 61 gatifloxacin recipients with hypoglycemia and 86 with hyperglycemia. Compared with other patients in the group, the gatifloxacin recipients had four times the risk of hypoglycemia and 17 times the risk of hyperglycemia.

"This is the most compelling evidence to date showing a connection between gatifloxacin and glucose problems," Frothingham said.

No other fluoroquinolone showed an unusual risk.

Juurlink said the study probably underestimated the risks of the drug. "If they died at home or in a pre-hospital setting, they would not have made it into the study," he said.

Study Finds Hyperglycemia Linked to Antipsychotic Medications – Validates Prior Research and Zyprexa Litigation Claims

Thu, 01 Dec 2005 00:00:00 -0800

A new study at the VA Connecticut Healthcare System, New Haven, Connecticut found that those taking atypical antipsychotic drugs may be at risk for developing high blood sugar (hyperglycemia).

The research, which was conducted by a team led by Dr. Michael J. Sernyak, monitored the frequency of undiagnosed high blood sugar in 647 patients taking various atypical antipsychotics, including: Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), or Geodon (ziprasadone). Over the course of two years, 153 of the participants had a fasting blood sugar result.

The study’s findings, published in the Journal of Clinical Psychiatry for December 2005, show that blood sugar levels were normal for 70% of the subjects, raised in 25% and extremely elevated in just over 5% of the participants.

Race, ethnicity, age, body mass index (BMI), or psychiatric diagnosis did not appear to have an impact on the development of high blood sugar.

Of all the antipsychotic medications, Clozaril was found to raise blood sugar in significantly more individuals than any of the other medications. The researchers did not find substantial differences for any of the other drugs.

According to the study, almost one in three patients taking atypical antipsychotics who thought their blood sugar levels were normal actually had abnormalities. The authors believe this finding should prompt the implementation of periodic screening even in large outpatient populations.

On June 10, newsinfern.com reported that Eli Lilly had agreed to pay $690 million to settle some 8,000 claims regarding its failure to adequately warn patients that Zyprexa posed an increased risk of diabetes and hyperglycemia.

Specifically, the claims were based on allegations that prior to September 2003, Lilly failed to adequately warn those taking Zyprexa of an increased risk of developing diabetes, hyperglycemia, and related illnesses.

While the pharmaceutical giant did not admit its best-selling drug caused the injuries in question, its potential exposure in the litigation far exceeded the settlement figure. Thus, as a business decision, resolving about 75% of the claims six months before trial made sense.

At the time, Jerrold S. Parker, senior partner in the prominent New York personal injury law firm of Parker & Waichman, told reporters that: “It’s really remarkable to arrive at a settlement of this magnitude so far in advance of trial.”

Mr. Parker said that the plaintiffs’ litigation team, made up of some of the foremost products liability attorneys, “was able to convince Lilly that plaintiffs’ case was a strong one, with a good likelihood of success, if it proceeded to trial.

The fund will be administered by a panel named by the plaintiffs’ attorneys which will allocate compensation to the plaintiffs based mostly on the extent of their injuries which range from weight gain to death.

Zyprexa, like two other powerful antipsychotic drugs, Risperdal (Jannsen Pharmaceuticals) and Seroquel (AstraZeneca), has been found to cause serious side effects in patients, especially those who have already been diagnosed with diabetes and related illnesses.

Knowledge of the dangers of Zyprexa was discovered as a result of a series of findings beginning in 2001 when the FDA was alerted to 19 case reports of diabetes associated with the drug.

One of these cases resulted in death due to necrotizing pancreatitis, a condition in which cells in the pancreas die. In May 2003, forty additional reports of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes were received in the UK including one which proved to be fatal.

An emergency report issued by the Japanese Health and Welfare Ministry in April of 2002 concerning the side effects of Zyprexa noted that there had been two deaths of patients who had diabetes prior to taking the anti-psychotic medication. It also reported that there had been seven other patients who lost consciousness or slipped into comas after taking the drug.

In April of 2003, the Wall Street Journal ran a front page article on Zyprexa and other anti-psychotics and their link to the development of diabetes. The article estimated that somewhere around 11 million people have taken Zyprexa.

An eight-year study found that nearly 300 patients developed diabetes, 75 became seriously ill, and 23 died. Although the FDA was aware of these cases, it did not require Lilly (and the manufactures of similar antipsychotic drugs) to add a significant warning regarding these risks until September 2003.

Zyprexa has been prescribed to more than 17 million people worldwide since it was first marketed in 1996. It became Lilly’s best selling medication, after Prozac lost U.S. patent protection in 2001, with annual sales of $4.4 billion or almost 33% of Lilly’s total sales of $13.86 billion.

The results of the newest study serve to confirm the findings reached in previous research as well as the validity of the claims that prompted Lilly’s settlement in June.

Study Finds Diabetes to be a 'Strong' Risk Factor for Sudden Cardiac Death

Sat, 19 Nov 2005 00:00:00 -0800

According to a new study published in the European Heart Journal, diabetes is a serious risk factor for sudden cardiac death with the danger escalating as the diabetes becomes more severe.

Researchers looked at individuals enrolled in the Group Health Cooperative of Puget Sound to determine the link between blood sugar level, diabetes, and the increased risk of sudden cardiac death.

The study included 2,040 subjects with a range of diabetic conditions such as borderline diabetes, diabetes without disease of the small blood vessels, and diabetes with disease of the small blood vessels.

These individuals experienced heart attacks between 1980 and 1994. There was also a control group consisting of 3,800 individuals without diabetes.

The research team found that there was a decidedly higher risk of sudden cardiac death associated with people with diabetes. Those with borderline diabetes were 24% more likely to experience sudden cardiac death than people without diabetes.

Individuals with diabetes without disease of the small blood vessels were 73% more likely to experience cardiac death, while people with diabetes with disease of the small blood vessels were a staggering 266% more likely to experience this potentially fatal health risk.

This information indicates that the relationship between diabetes and sudden cardiac death may involve heart disease, atherosclerosis, or a combination of the two. High blood sugar levels can cause small blood vessel disease without visible symptoms, possibly leading to a greater risk of sudden cardiac death as well.

Study Estimates 2 Million U.S. Children at Risk for Diabetes and Heart Problems

Tue, 08 Nov 2005 00:00:00 -0800

According to government data, some 2 million U.S. adolescents (12 to 19) have a pre-diabetic condition called “impaired fasting glucose” (IFG), which puts them at risk for developing cardiovascular problems and full-blown diabetes.

IFG manifests itself in the form of abnormally high blood-sugar levels even after several hours without eating. Research done by the National Institutes of Health and the Centers for Disease Control and Prevention (CDC) indicates that one in 14 children (boys and girls) in a nationwide sample had the condition. In overweight children, the ratio was even higher at one in six.

Average levels of triglycerides and bad cholesterol were also higher in children who had IFG.

The study, which appears in the November issue of Pediatrics, is based on data from 915 children who were involved in a 1999-2000 national health survey.

Currently, some 20 million Americans have diabetes. The majority of them are adults, who have Type 2 diabetes, which hinders the body’s ability to use insulin. Type 2 diabetes is closely linked to inactivity and obesity.

Although most American adolescents with diabetes (some 177,000) have Type 1, in which the body produces little or no insulin, Type 2 is on the rise.

The American Diabetes Association defines IFG as fasting blood-sugar levels of least 100 milligrams per deciliter. A fasting blood sugar level above 125 is considered diabetes.

Among tested youngsters, the average level was 89.7, which is within normal range. However, 7% of the children studied were in the pre-diabetic range. That percentage translates to roughly 2 million U.S. youngsters. About 16% of the subjects were obese; a figure that parallels the current nationwide estimate.

Although IFG has no symptoms, it represents a serious metabolic problem which, in time, usually develops into Type 2 diabetes. According to the researchers, significant lifestyle changes, such as exercise and improved diet, have shown to stop pre-diabetes from progressing in adults, so it is likely that the same program can help children.

Study Finds Diabetics Have Higher Risk of Colorectal Cancer

Tue, 01 Nov 2005 00:00:00 -0800

A study conducted by researchers from the Medical University of South Carolina and presented at the 70th Annual Scientific Meeting of the American College of Gastroenterology (ACD) examined data from a comprehensive nationally representative sample of patients using the 1997-2003 National Health Interview Survey.

This resulted in a study group of 226,953 patients of which, 5.9% had a history of diabetes.

After researchers controlled for age, race, gender, obesity, alcohol use, tobacco use, and physical activity and adjusted for potentially confounding factors, the researchers found that people with diabetes were 1.4 times more likely to have colon cancer as individuals without diabetes.

According to Dr. Donald Garrow, a member of the research team: "This work is important because it suggests that people with diabetes may be at higher risk of colon cancer. Until we know for sure, diabetics should pay particular attention to their doctor's recommendations for colorectal screening,"
The news release from the meeting in Honolulu can be found at:

http://www.acg.gi.org/media/releases/ACG05Release_DiabetesRiskforCRC.pdf
The ACD was formed in 1932 “to advance the scientific study and medical treatment of disorders of the gastrointestinal (GI) tract.” The organization sponsors a number of programs through which consumers can obtain helpful information on GI diseases. Links to those programs can be found at www.acg.gi.org.

Diabetic Pregnancy Can Cause Birth Defects

Thu, 06 Oct 2005 00:00:00 -0700

The babies of women with diabetes are two to five times more likely to develop birth defects than the offspring of women without the disease.

A recent study by Joslin Diabetes Center scientists suggests that high blood glucose levels early in pregnancy deprive the embryo of oxygen, interfering with its development. The research appears in the October issue of the American Journal of Physiology: Endocrinology and Metabolism.

Women with both type 1 and type 2 diabetes run a high risk of having babies with birth defects, especially of the heart and spinal cord. Because these organs form during the first few weeks of pregnancy, coinciding with the time that a woman may first learn that she is pregnant, aggressive control of blood glucose levels just before and after conception is critical.

The study’s lead investigator, Dr. Mary R. Loeken, Ph.D., recommends that obese women who don’t know if they have diabetes but who are planning to become pregnant be tested for diabetes. “Many obese women have type 2 diabetes and do not know it, so it is a good idea to bring glucose levels to within the normal range before becoming pregnant, and to monitor women with pre-diabetes closely during pregnancy to make sure they don’t develop diabetes,” Dr. Loeken says.

In the new study, Dr. Loeken and her colleagues examined embryos of pregnant mice injected with glucose (the sugar that is elevated in blood during diabetes) to mimic diabetic pregnancy. They found that the oxygen concentrations in embryos of mice injected with glucose were significantly lower than in the control embryos, and that embryos from pregnant mice with high blood glucose levels had an eight-fold increase in a severe type of birth defect called neural tube defects.

Neural tube defects occur when parts of the brain, spinal cord, or their protective coverings fail to develop properly. Neural tube defects and heart abnormalities are the most common birth defects affecting babies born to women with diabetes.

Specialized Breath Tests Will Aid in the Detection of a Number of Diseases

Sun, 21 Aug 2005 00:00:00 -0700

A new, highly sensitive breath test promises to provide doctors with a new diagnostic tool to help spot several diseases and to identify if a patient is rejecting an organ transplant.

If this test is adopted it could make determining diseases easier and provide an alternative to more costly or complicated diagnostic tests.

The test was developed by Dr. Michael Phillips who anticipates it will soon be able to help detect a variety of diseases including lung cancer, breast cancer, kidney disease, and diabetes.

The test may also be able to identify the signals of transplant rejection thereby reducing the number of biopsies these patients must undergo.
Phillips is currently seeking to license a company to produce and market his Heartsbreath test to doctors and hospitals.

He explained that analyzing breath, especially for diabetic patients, is an ancient practice and that his machinery, which can identify 200 compounds, is about billion times stronger at sensing a substance than the police Breathalyzer that measures alcohol level.

According to Phillips, the technology works because every illness generates an abundance of free radicals which oxidize cell membranes and release distinct compounds. Thus, every one has its own identifiable "fingerprint."

The software Phillips has designed will be able to isolate this fingerprint using a gas chromatograph and mass spectrometer, two common pieces of analytical laboratory equipment.

During the test the patient puts on a nose clip and breathes into a tube for two minutes. The sample is captured in a 4-inch steel tube the width of a pencil, which is stuffed with absorbent material. The contents, along with those of another tube that has collected air from around the patient, are compared by the chromatograph and spectrometer.

The Heartsbreath test was approved by the Food and Drug Administration in 2004 after federally sponsored clinical trials. It is a less invasive procedure for the 2,000 patients a year who have heart transplants. These patients often require as many as 20 biopsies, sometimes costing as much as $2,500, in the first year after surgery.

Along with traditional blood tests and other diagnostic tools, Heartsbreath could become a reliable means of identifying signs of organ rejection in these individuals.

DIABETICS FACE INCREASED RISK OF HEART DISEASE FROM AIR POLLUTION

Thu, 02 Jun 2005 00:00:00 -0700

A study of Boston area residents conducted by researchers at the Harvard School of Public Health and funded by the National Institute of Environmental Health Sciences (one of the National Institutes of Health) suggests that diabetics may be at higher risk for cardiovascular problems when they are exposed to elevated levels of air pollution from vehicular traffic and coal-burning power plants.

It appears that ability of blood vessels to control blood flow is adversely affected most by sulfate particles (from coal-burning power plants) and ultra-fine particles and back carbon soot (generated by diesel and gasoline engines).

Previous studies have found that elevated levels of air pollution are linked to higher rates of hospitalization and death from cardiovascular problems in people with diabetes. This study found, that on days when sulfate particle levels were elevated, vascular reactivity was 11% lower in the test subjects with diabetes. On days when the levels of black carbon were higher than normal, the diabetics showed a 13% decrease in their vascular reactivity. The findings appear in the June issue of the journal Circulation.

Parker & Waichman Files Claims Against Eli Lilly and Company on Behalf of Three Individuals Claiming Injuries Caused by Zyprexa; Plaintiffs Diagnosed with Serious Cases of Diabetes and Pancreatitis

Fri, 19 Mar 2004 00:00:00 -0800

Parker & Waichman LLP (www.yourlawyer.com) filed claims against Eli Lilly and Company (NYSE: LLY - News) on behalf of three individuals who claim to have sustained severe side-effects from Zyprexa. The claims were filed in Federal District Court in the Eastern District of New York. Two plaintiffs have been diagnosed with serious cases of diabetes, and another plaintiff has required lengthy intensive care hospitalization due to a diagnosis of acute pancreatitis. Zyprexa is currently the most popular atypical antipsychotic medication, and is Eli Lilly and Company's best-selling pharmaceutical. Zyprexa users can visit www.zyprexa-side-effects.com for more information on these claims.

The British Medical Control Agency and the Japanese Health and Welfare Ministry have both warned about the risk of diabetes in patients who are prescribed Zyprexa. In 2002, a study at Duke University showed a connection between Zyprexa and diabetes. This study documented nearly 300 cases of diabetes in people using Zyprexa. Only recently has Eli Lilly and Company added some language to their labeling in the United States concerning the risk of diabetes from Zyprexa.

"We are confident that we will bring justice to our clients whose lives have been permanently affected by the side-effects of a drug that provides little efficacious benefit, but causes life-threatening injuries," commented Jerrold S. Parker, Co-Founder of Parker & Waichman.

"With the alarming studies that have been conducted and the warnings from national health agencies about Zyprexa's link to blood sugar disorders, it is appalling that Eli Lilly has not issued adequate warnings and that they continue to market this drug heavily directly to consumers."

Zyprexa was approved for the treatment of schizophrenia in 1996 and for the treatment of bipolar mania in 2000. It is part of a new generation of antipsychotics known as atypicals, which include Seroquel, Risperdal, Abilify, Clozaril, and Geodon. Ironically, the primary advantage of the newer atypical antipsychotic medications was supposed to be a lower incidence of side effects than the conventional antipsychotics introduced in the 1950s (Haldol, Thorazine, Prolixin, Navane, Stelazine, Trilafon, and Mellaril).

More information on Zyprexa side-effects is available at Parker & Waichman's Zyprexa website www.zyprexa-side-effects.com. Current and former Zyprexa users can visit this to request a free legal evaluation.

For more information on Parker & Waichman, LLP please visit http://www.yourlawyer.com or call 1-800-LAW-INFO. Current and former shareholders are also encouraged to visit http://www.injurytalk.com.

Contact:

David Krangle, Esq.
Parker & Waichman, LLP
1-800-LAW-INFO (1-800-529-4636)
http://www.yourlawyer.com
dkrangle@yourlawyer.com

Zyprexa Atypical Antipsychotics Diabetes Side Effect Lawyer

Fri, 19 Mar 2004 00:00:00 -0800

Diabetes

Several prescription medications have been associated with causing diabetes. Studies have shown that atypical antipsychotic drugs including: Zyprexa, Risperdal, Seroquel, and Geodon can cause diabetes. These drugs have also been linked with other blood sugar disorders including hyperglycemia and pancreatitis. Antipsychotics are commonly prescribed to treat patients diagnosed with schizophrenia. Additionally, the impotence drug Levitra and the antibiotic Tequin can cause diabetes.

Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles.

There are 18.2 million people in the United States, or 6.3% of the population, who have diabetes. While an estimated 13 million have been diagnosed with diabetes, unfortunately, 5.2 million people (or nearly one-third) are unaware that they have the disease. Often diabetes goes undiagnosed because many of its symptoms seem so harmless. Recent studies indicate that the early detection of diabetes symptoms and treatment can decrease the chance of developing the complications of diabetes.

Some diabetes symptoms include:

Frequent urination
Excessive thirst
Extreme hunger
Unusual weight loss
Increased fatigue
Irritability
Blurry vision

If you or a loved one has taken prescription medications and been diagnosed with Diabetes, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.