December 27, 2007 (EurekAlert) - People with high triglycerides and another type of cholesterol tested but not usually evaluated as part of a person's risk assessment have an increased risk of a certain type of stroke, according to research published in the December 26, 2007, online issue of Neurology®, the medical journal of the American Academy of Neurology. "LDL or 'bad' cholesterol has been the primary target for reducing the risk of stroke, but these results show that other types of cholesterol may be more strongly linked with stroke risk," said study author Bruce Ovbiagele, MD, of UCLA Medical Center in Los Angeles, CA, and member of the American Academy of Neurology.
The researchers analyzed the records of 1,049 people admitted to a university hospital with a stroke or mini-stroke over four years. Of those, 247 people had a large artery atherosclerotic stroke. This is a type of ischemic stroke caused by a blockage of blood flow to the brain. People with this type of stroke have blockage in the large arteries leading to the brain.

Those with high triglycerides and elevated "non-high density lipoprotein cholesterol" were more likely to have a large artery atherosclerotic stroke than those with low levels of these fats in the blood.

Those with the highest triglycerides were 2.7 times more likely to have this type of stroke than those with the lowest level. Triglycerides are fatty acids and are the most common type of fat in the blood. Those with the greatest non-high density lipoprotein cholesterol, which is neither the "good" nor the "bad" cholesterol, were 2.4 times more likely to have a large artery stroke.

"Because this type of cholesterol is included in the test that is normally ordered, and triglycerides are already reported, it would not be difficult to start paying closer attention to these factors in people at risk for large artery stroke," Ovbiagele said.

The study found that people with high "bad" cholesterol did not have an increased risk of this type of stroke. Ovbiagele noted that it is still important to monitor bad cholesterol levels to reduce risk of heart disease and other types of stroke.

December 21, 2007 (Bayer) - Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Company identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of our product specifications. Test results may demonstrate results 5 -17% higher.This issue is unrelated in any way to the Contour TS meter itself and pertains only to certain test strips used with the meter. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems.

The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips. The root cause of the problem has been identified, and corrective actions implemented including additional quality control measures to prevent recurrence. The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed - France, Austria, Turkey, Korea, Mexico, India and predominantly through mail order channels in the United States.

Healthcare providers, retailers, patients and other customers who use Contour TS are advised to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips. The lot numbers can be found on the bottom of the box and on the side of the bottle containing the strips. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected. Bottles with a lot number including 7J through 7M after WK are not affected and need not be returned. Additional information can be found at www.bayerdiabetes.com. Please call your Bayer customer service phone number (in the U.S., call 1-800-348-8100) to return any affected bottle of strips and to get a replacement.

November 10, 2006 (FDA) - The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500mg caplets are affected by this recall. For a list of batches affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall is located on FDA's website at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.

Consumers who believe they are in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department, 877-546-0454 for further instructions. Any adverse reactions experienced with the use of this product should be reported to Perrigo at the above number and the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178 or on the MedWatch website at www.fda.gov/medwatch.

FDA is currently investigating the cause of the metal particles found in the acetaminophen 500 mg. caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely. The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in caplets of acetaminophen, 500 mg. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from "microdots" to portions of wire 8 mm in length.

At this time FDA does not anticipate that this action will cause a shortage of acetaminophen. Currently, only one strength (500 mg caplets) is affected. Consumers may wish to take additional amounts of the lower strengths of acetaminophen tablets or caplets, which are not affected by this recall, to reach the 500 mg dose or access acetaminophen produced by alternate manufacturers. In all instances, FDA advises consumers to follow labeled instructions for maximum daily dosage.

Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.

November 9, 2006 (EurekAlert) - Giving people at high risk for type 2 diabetes intensive diet and exercise counselling can result in sustained lifestyle changes and a reduction in diabetes incidence, even after active counselling ceases, according to the extended follow-up of the Finnish Diabetes Prevention Study (FDPS) published in this week's Lancet.Around 50% of people with impaired glucose tolerance will develop diabetes during 10 years when no active intervention is applied. In the original FDPS study, overweight, middle-aged people with impaired glucose tolerance were randomly assigned to an intensive lifestyle intervention or control group. The intervention group were given detailed and individualised counselling to achieve lifestyle goals (weight loss, decreased intake of fat and saturated fat, increased fibre intake, and moderately intense physical activity 30 min per day or more). After 4 years of active counselling, the intervention group achieved a 58% reduction in relative risk of type 2 diabetes compared with the control group.

The extended follow-up of the FDPS study assessed the extent to which the originally-achieved lifestyle changes and risk reduction remained after discontinuation of active counselling. Jaana Lindström (National Public Health Institute, Helsinki, Finland) and colleagues found that beneficial lifestyle changes achieved by participants in the intervention group were maintained after the discontinuation of the intervention, with a 36% reduction in relative risk. The overall risk reduction was related to the success in achieving the intervention goals of weight loss, reduced intake of total and saturated fat, and increased physical activity and intake of dietary fibre. The study (with a median follow-up of 3 years after active counselling) shows that a marked difference in the cumulative incidence of diabetes can be sustained after the discontinuation of active counselling.

Jaakko Tuomilehto, the other principal investigator of the Finnish Diabetes Prevention Study states: "From a public health point of view there is an important message: an intensive lifestyle intervention lasting for a limited time can yield long-term benefits in reducing the risk of type 2 diabetes in high-risk individuals…Although a lifestyle intervention alone, even if successful, does not necessarily prevent type 2 diabetes in all individuals, it will still postpone the onset of the disease. Even delaying the onset of diabetes can have a substantial effect on subsequent morbidity, and therefore on the cost-effectiveness of diabetes prevention".