FDA Updates Nationwide Class 1 Recall Alert on Counterfeit One Touch Blood Glucose Test Strips

December 2006: The U.S. Food and Drug Administration (or FDA) has updated it’s notifications on October 13, and October 23, 2006, which alerted the public to counterfeit blood glucose test strips, for use with various LifeScan, Inc., One Touch Brand Blood Glucose Monitors, being sold in the U.S.

The recall is being classified as a Class 1 by the FDA because the counterfeit test strips have a significantly dangerous alteration in performance. These counterfeit test strips can potentially give a false reading of blood glucose levels which may result in a patient taking an incorrect dosage of insulin leading to serious injury or death.

The concerned products are counterfeit and as such are not being marketed or distributed by LifeScan. LifeScan is not responsible for the recall, however, companies or firms that are distributing these counterfeit products are responsible for the recall and corrective measures developed by LifeScan, with input from the FDA. The FDA is continuing it’s on-going efforts with LifeScan and the distributors of these counterfeit products to ensure that they are all removed from the market.

The counterfeit test strips are as follows:

· One Touch® Basic®/Profile® (lot #272894A, 2619932, 2606340, 2615211 (added October 23, 2006) and 227078A (new lot)) test strips, and

· One Touch® Ultra® (lot #2691191 and 2691261 (added October 23, 2006) test strips.

LifeScan, Inc. made the FDA aware of the new lot of counterfeit products. The FDA has been investigating this issue and whether or not there have been any adverse events that have transpired due to the counterfeit products.

Any consumer who has received these counterfeit test strips should immediately discontinue use, contact their physician, and replace the strips as soon as possible. If you have received one of the counterfeit products and have any questions, you can contact LifeScan, Inc. at 1-866-621-4855.

For a comprehensive guide on how to identify if your product is counterfeit, visit LifeScan’s web site at: www.lifescan.com/company/about/press/counterfeit/

These characteristics may help you identify the counterfeit strips:

Counterfeit One Touch Basic/Profile Test Strips, lot numbers 272894A, 2619932, and 2606340

• Lot Numbers 272894A, 2619932, or 2606340 appears on the outer carton and on the inside container (vial).
• The outer carton is written in Multiple Languages including English, Greek and Portuguese.
• The outer carton is labeled as 50-Count One Touch (Basic/Profile)Test Strip packages
• The bottom of the outer carton does not include an NDC number.

Counterfeit One Touch Basic/Profile Test Strips, lot numbers 2615211 and (227078A (new lot))

• Lot Numbers 2615211 or 227078A appear on the outer carton and on the inside container (vial).
• The outer carton is written in English.
• The outer carton is labeled as 50-Count One Touch (Basic/Profile) Test Strip packages.
• A picture of a hand appears on the test strip displayed on the outer carton.
• The inside container (vial) is labeled as "plasma calibrated"
• The bottom of the outer carton does not include an NDC number.

Counterfeit One Touch Ultra Test Strips, lot numbers 2691191 and 2691261

• The lot numbers 2691191 or 2691261 appears on the outer carton and on the inside container (vial).
• The outer carton and inside container (vial) is written in both English and French.
• The outer carton is labeled as 50-Count One Touch Ultra Test Strip packages.
• The bottom of the outer carton does not include an NDC number.

Any problems experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Top 6 Risk Factors for Developing Type 2 Diabetes

There are numerous risk factors for developing type 2 diabetes. Factors such as hamily history and genetics are going to be with us always, however, there are many other risk factors that can be prevented and put you at a lower risk. We will go over these risks and what we can do to prevent them.

1) Obesity

This is the number one risk factor for type 2 diabetes. Higher weight puts you at higher risk of insulin resistance because fat will impair the body's ability to use the insulin it is creating. The National Center for Health Statistics has stated that 30 percent of adults are obese and the number of overweight kids has tripled since 1980. This means that over 60 million adults and children are at a higher risk of developing type 2 diabetes.

2) Sedentary Lifestyle

The Surgeons General's Report on Physical Actiity and Health, published in 1996, stated "a sedentary lifestyle is damaging to health and bears responsibility for the growing obesity problems". Obesity and inactivity greatly increse your risk of developing type 2 diabetes. Muscle cells have many more insulin receptors than fat cells, meaning that you can decrease insulin resistance by exercising regularly. Being active and exercising also lowers your blood sugar levels by making insulin more efficient.

3) Unhealthy Eating habits

90% of people who are diagnosed with Type 2 diabetes are overweight. The number one cause of obesity is unhealthy eating habits. Eating too much fat and simple carbohydrates without enough fiber can contribute greatly to a diagnosis of Type 2 diabetes. A more healthy diet can help you prevent Type 2 diabetes.

4) Increased Age

As our age increases, so does our risk of developing Type 2 diabetes. Even if an elderly person is in good shape, their risk for Type 2 will still be greater. Scientists believe that this is due to an aging pancreas that is not as efficient as when we were younger. Our cells age as well and become more resistant to insulin.

5) High Blood Pressure and High Cholesterol

These two factors are large risk factors for many diseases and conditions, including Type 2 diabetes. They are two key factors of Metabolic syndrome which is a group of symptoms including obesity, a high fat diet, and lack of exercise. Metabolic syndrome can increase your risk of heart disease, stroke and diabetes.

6) History of Gestational Diabetes

This condition affects about 4% of pregnant women. It occurs when the placenta hormones make the mother's cells more resisntant to insulin. Many of these women will be at risk for developing type 2 diabetes later on in life. Also, their babies will have an elevated risk of developing diabetes.

Diabetes Medication May Slow Thickening of Artery Walls

A medication that is being prescribed to patients with diabetes appears to not only increase their body’s sensitivity to insulin, but also slow the thickening of their artery walls. A study posted online by JAMA confirms these results and will be presented at the American Heart Association Scientific Session.

It has already been proven that people with diabetes suffer from an increased risk of heart attack Controlling cholesterol (LDL) and blood pressure has been shown to lower some of this excess risk. “However, even with optimal control of these potent cardiovascular risk factors, incremental risk for cardiovascular events remains high compared with individuals without diabetes,” the authors say. “New approaches are, therefore, needed to further reduce cardiovascular risk in patients with diabetes.”

Theodore Mazzone, M.D., of the University of Illinois at Chicago College of Medicine, and his colleagues studied a drug called pioglitazone to see if it may help to reduce the excess risk of heart attack in patients with diabetes. The studied included 462 adults with type 2 diabetes in the Chicago area from 2003 to 2006. The average age of the group was 60 years and included 289 men and 173 women. These participants were randomly assigned to take either 15 to 45 milligrams of pioglitazone or 1 to 4 milligrams of glimepiride, another medication with the same effects but through different mechanisms. At the beginning of the study, an ultrasound was used to measure the thickness of the carotid arteries. A measure of glucose control, blood pressure, and blood cholesterol levels were also monitored throughout the study.

In total, 158 patients using pioglitazone and 165 patients using glimepiride completed the entire 72 week trial. At the beginning of the study, the two groups had comparable artery wall thickness. At the end of the study, the glimeperide groups average artery wall thickness increased by .012 millimeters while the pioglitazone groups average dropped by .001. “A pre-specified subgroup analysis based on age, sex, systoloc blood pressure, duration of type 2 diabetes mellitus, body mass index, hbA1c value and statin use showed a uniform beneficial effect of the pioglitazone treatment,” the authors write.

Over the course of the study, blood pressure remained very similar between both groups. By week 48, however, the pioglitazone group was significantly lower than the glimeperide group. HDL, or “good” cholesterol increased in the pioglitazone group and remained higher throughout the remainder of the study. These measurements represent that pioglitazone can reduce artery wall thickness.

"Additional data will be needed to determine the clinical significance of these findings; specifically, whether a strategy of routine use of pioglitazone instead of glimepiride substantially reduces major cardiovascular events," they concluded.

Job Burnout May Increase Risk of Developing Diabetes

A recent Israeli study suggests that job burnout may increase your risk of developing a form of diabetes.

This study, which is the first of its kind, does not confirm that there is a link between work related stress and diabetes. However, the research suggests that job burnout could increase your risk of illness by a “magnitude similar to other risk factors, such as high body mass index, smoking, and lack of physical exercise,” according to the studies lead author Samuel Melamed, an associate professor at the Tel Aviv University in Israel.

Researchers followed 677 Israeli workers from 1998 to 2003. Close to 77 percent of the workers were men with an average age of 43 years.

Of the 677 workers, 17 of them developed type 2 diabetes during the research period. The researchers concluded that people experiencing job burnout were 1.84 times more likely to develop diabetes, even when factors such as obesity, age and sex were taken into account.

The researchers also looked at a smaller sample of 507 workers and tried to eliminate the possibility of blood pressure levels having an effect. They concluded that workers were more than 4.32 times more likely to develop type 2 diabetes.

Melamed states that job burnout may only be a part of the picture. “It is possible that these people are prone to diabetes because they can’t handle stress very well,” says Melamed. “Their coping resources may have been depleted not only due to job stress but also life stresses, such as stressful life events and daily hassles.”

Stress can, indeed, disrupt the bodies ability to process glucose especially in those who are genetically prone to a diabetes vulnerability, according to Richard Surwit, chief of the Division of Medical Psychology at Duke University medical Center.

Surwit suggests that the researchers use a much larger sample to get a better result. He states that the research author “needs to look at hundreds of thousands of people to see if he gets the same thing.”