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FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings Archived news headlines Editorials Main News Index If you copy our list of links for your own site, we'd really appreciate it if you would add a link to our site as well. Your support and mention of www.IsletsofHope.com will help others with diabetes. We donate 100% of the profits from our website to nonprofit diabetes organizations that purchase insulin, diabetes medications, and supplies for others in need. 2004 FDA Diabetes-Related Releases New Awareness Campaign for Asian Americans and Pacific Islanders - Source: Millions of Asian Americans and Pacific Islanders at Increased Risk for Type 2 Diabetes, NIH/NIDDK Press Release, September 29, 2004 - About 40 percent of adults ages 40 to 74 have pre-diabetes, a condition that raises a person’s risk for developing type 2 diabetes, heart disease, and stroke. Studies show that Asian Americans and Pacific Islanders who are overweight are at increased risk for type 2 diabetes, and some groups, including Native Hawaiians, Filipinos, and Japanese Americans living in Hawaii, are twice as likely to have diabetes as white residents of similar age. To respond to this serious health threat, the U.S. Department of Health and Human Services’ (HHS) National Diabetes Education Program (NDEP) launched a public awareness campaign. Read full FDA report New Drug Approved for Pain Related to Diabetes - Source: FDA Approves Drug for Neuropathic Pain Associated with Diabetes, FDA News, September 7, 2004 - FDA has announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Read full FDA report New Diabetes Awareness Campaign to Reach American Indians and Alaska Natives - Source: Millions of American Indians and Alaska Natives at Increased Risk for Type 2 Diabetes, NIH/NIDDK Press Release, August 10, 2004 - About 41 million people have pre-diabetes, a condition that raises a person’s risk of developing type 2 diabetes, heart disease, and stroke. American Indians and Alaska Natives are 2.3 times as likely to have diabetes as non-Hispanic whites of similar age. To respond to this rapidly growing problem, the U.S. Department of Health and Human Services’ National Diabetes Education Program (NDEP) launched a public awareness campaign called "We Have the Power to Prevent Diabetes." - Read full FDA report New Diabetes Education Program to Reach Hispanic Communities - Source: Millions of Hispanics at Increased Risk for Type 2 Diabetes, NIH/NIDDK Press Release, June 29, 2004 - About 40 percent of U.S. adults ages 40 to 74 – millions of whom are Hispanic or Latino – currently have pre-diabetes, a condition that raises a person’s risk of developing type 2 diabetes, heart disease, and stroke. To respond to this rapidly growing problem, experts from the U.S. Department of Health and Human Services’ National Diabetes Education Program (NDEP) and community-based organizations from around the country met to discuss national and local efforts to stem the diabetes epidemic in the Hispanic community. Read full FDA report Newly Formed Network Launches First Studies - Source: TrialNet Launches First Studies in Type 1 Diabetes, NIH/NIDDK News, June 5, 2004 - Type 1 Diabetes TrialNet, a newly formed network of 18 clinical centers in the United States, Canada, Europe, and Australia, has launched its first two clinical studies, DHHS Secretary Tommy G. Thompson announced on June 5, 2004. One study examines the biological basis of type 1 diabetes in at-risk people. The other seeks to preserve insulin-secreting beta cells in patients newly diagnosed with type 1 diabetes. Additional studies will become available as researchers develop protocols to test promising preventions and treatments. Read full FDA report Diabetes Linked to Risk of Alzheimer’s Disease - Source: Diabetes linked to Increased Risk of Alzheimer’s in Long-Term Study, NIH News, May 19, 2004 - Diabetes mellitus was linked to a 65 percent increased risk of developing Alzheimer’s disease, appearing to affect some aspects of cognitive function differently than others in a new study supported by the National Institute on Aging (NIA) at the National Institutes of Health. The findings add to a developing body of research examining a possible link between diabetes and cognitive decline. Read full FDA report American Diabetes Association Reports Blood Pressure Drugs Reduce Death Rate - Source: Blood Pressure Drugs Cut Death Rate in Half, ADA Diabetes News, May 26, 2004 - ACE inhibitors, a type of medication often used to treat high blood pressure or heart disease, can lower the death rates for people who have diabetes -- whether they have cardiovascular disease or not, according to a study published in the June issue of Diabetes Care. The study found that the use of ACE inhibitors among a broad spectrum of people newly treated for diabetes cut in half the risk of death from all causes and reduced the risk of death from cardiovascular disease by 23 percent. Read full FDA report Recall of Minimed Paradigm Quick-Set® Plus Infusion Set - Source: Medtronic Recalls Quick-Set® Plus Infusion Sets, Medtronic News Release, May 18, 2004 - Medtronic, Inc. has recalled all Paradigm Quick-Set® Plus infusion sets because of problems that can prevent insulin flow during use. These problems have resulted in a number of serious injuries, including some hospitalizations. Patients should stop using the Paradigm Quick-set Plus infusion sets as soon as they can get replacements. Patients can request free replacement sets by calling Medtronic's 24-hour Help Line at 800-646-4633 (option 1) or using the on-line form at www.minimed.com/QSP. Read full news release New Drug for Dogs with Diabetes - Source: FDA Approves First Insulin Drug for Diabetic Dogs, FDA News, May 4, 2004 - FDA has approved the first drug for treating diabetic dogs. Before the development of this drug, the only treatment veterinarians could use on diabetic dogs was human insulin, which is less compatible with a dog’s metabolic system. Estimates are that one in every 200 dogs will develop diabetes. The onset usually occurs in dogs aged 7-9 years, and seems to be twice as prevalent in females as in males. Read full FDA report New Prevention Campaign for High Risk Groups - Source: HHS Launches Diabetes Prevention Campaign to Reach High Risk Groups, NIH/NIDDK Press Release, April 28, 2004 - DHHS Secretary Tommy G. Thompson and the National Diabetes Education Program (NDEP) launched the first national multicultural diabetes prevention campaign, Small Steps. Big Rewards. Prevent type 2 Diabetes, to take action against the growing diabetes epidemic. The campaign focuses on empowering people at high risk to make modest lifestyle changes that can prevent or delay the onset of type 2 diabetes. Read full FDA report Millions More Have Pre-Diabetes - Source: Revised Definition Means Millions More Have Pre-Diabetes, DHHS Press Release, April 29, 2004 - “Pre-diabetes” – a condition that raises a person’s risk of developing type 2 diabetes, heart disease, and stroke – is far more common in America than previously believed, according to a new DHHS estimate released today. About 40 percent of U.S. adults ages 40 to 74, or 41 million people, currently have the condition, which is marked by blood glucose levels that are higher than normal but not yet diabetic. Many people with pre-diabetes go on to develop type 2 diabetes within 10 years. Read full FDA report FDA/NIH Joint Symposium on Diabetes - FDA and NIH will host a joint symposium targeting safe and effective prevention and treatment of diabetes, May 13 - 14, 2004. The purpose of the symposium is to define the current state of the prevention and management of diabetes and to identify and discuss therapeutic gaps and hurdles to safe and effective prevention and treatment of type 1 and type 2 diabetes mellitus. The symposium will provide a forum for discussion of diabetes-related topics. Additional information New Strategy to Help Reduce Obesity - Source: HHS Unveils FDA Strategy to Help Reduce Obesity, DHHS Press Release, March 12, 2004 - HHS Secretary Tommy G. Thompson released a new Food and Drug Administration (FDA) report on March 12, 2004 outlining another element in HHS' comprehensive strategy for combating the epidemic of obesity that threatens the health of millions of Americans with a focus on the message, "calories count." The report by FDA's Obesity Working Group includes recommendations to strengthen food labeling, to educate consumers about maintaining a healthy diet and weight and to encourage restaurants to provide calorie and nutrition information. It also recommends increasing enforcement to ensure food labels accurately portray serving size, revising and reissuing guidance on developing obesity drugs and strengthening coordinated scientific research to reduce obesity and to develop foods that are healthier and low in calories. Read full FDA report Dietary Guidelines for Americans 2005 - Diabetes: A National Plan for Action - Source: Secretary Announces Plan to Fight Diabetes, Highlights Efforts to Promote Prevention, DHHS Press Release, December 7, 2004 - HHS Secretary Tommy G. Thompson announced Diabetes: A National Plan for Action. This plan is a step-by-step guide to activities and resources against a disease that affects more than 18 million Americans. Read full FDA story - 12/07/2004 New Family Health History Initiative - Source: HHS Launches New Family Health History Initiative, DHHS Press Release, November 8, 2004 - HHS Secretary Tommy G. Thompson launched a Family History Initiative to encourage all Americans to learn about their families' health histories as a way of promoting personal health and preventing disease. Americans are encouraged to use their family gatherings as a time to collect important family health history information that can benefit all family members. Read full FDA story Family History Initiative
website - HHS Statement on Institute of Medicine Report on Childhood Obesity Preventing Childhood Obesity - Source: Preventing Childhood Obesity: Health in the Balance, Institute of Medicine (IOM) Report, September 30, 2004 - In response to a request from Congress for a prevention-oriented action plan to tackle the alarming rise in childhood obesity, the IOM Committee on Prevention of Obesity in Children and Youth has developed a comprehensive national strategy that recommends specific actions for families, schools, industry, communities, and government. The committee‘s findings and recommendations are described in the report Preventing Childhood Obesity: Health in the Balance. Read full FDA report
Safety Alert about Antipsychotic Medications and Diabetes - Source: 2004 Safety Alert: Zyprexa (olanzapine), FDA MedWatch Safety Alert, March 1, 2004 - Eli Lilly and Company sent a Dear Doctor letter on March 1, 2004 to inform them of important labeling changes regarding Zyprexa (olanzapine). The Food and Drug Administration (FDA) has asked all manufacturers of atypical antipsychotic medications, including Lilly, to add a Warning statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Zyprexa. Read full FDA report Americans Not Aware of Their Blood Sugar Levels - Source: Awareness of Blood Sugar Critically Lacking Despite Diabetes Increase, American Diabetes Association Survey Finds, ADA Press Release, March 23, 2004 - A new national survey conducted by the American Diabetes Association reveals that 7 out of 10 Americans are not aware of their blood glucose (sugar) level (critical information for determining the presence of diabetes or pre-diabetes). This awareness level is considered extremely low, especially as it relates to individuals’ knowledge of blood pressure and cholesterol. Read full FDA report 2003 FDA Diabetes-Related Releases Roche Issues Alert About False Expiration Dates on Imported Advantage II Glucose Test Strips - (February 1, 2003) - Roche Diagnostics Corporation has alerted healthcare providers that some lots of Advantage II test strips, which are intended solely for distribution outside of the U.S., have been repackaged and reimported into the U.S. as Accu-Chek® Comfort Curve® test strips, in some cases with altered expiration dates. These lots were never distributed in the U.S. and are not cleared for sale in the U.S. by the FDA. Problems with these test strips include: incorrect expiration dates, improper calibration for U.S. glucose meters, and questionable product performance due to unknown storage or handling conditions by the importer. Read FDA's Dear Healthcare Provider Letter 2002 FDA Diabetes-Relates Releases FDA Clears Home Glycated Hemoglobin Test For Diabetics - December 17, 2002. (Read FDA Release) FDA Approves GlucoWatch for Children With Diabetes - August 27, 2002. (Read FDA Release) NEW PRODUCT ALERT - FDA CLEARS NEW PALM TEST FOR SKIN CHOLESTEROL - 06/24/2002 - Read FDA Release NEW PRODUCT ALERT - FDA CLEARS TWO GLUCOSE TEST METERS - FDA has cleared for marketing two glucose test meters used with personal digital assistants (PDAs). 06/13/2002 Read FDA Release STUDY EXAMINES COST-EFFECTIVENESS OF TREATMENT INTERVENTIONS FOR TYPE 2 DIABETES - Aggressive treatment of high blood pressure can improve health outcomes while reducing a diabetes patient's lifetime health care costs by about $1,000, according to a new study by the Centers for Disease Control and Prevention (CDC). 05/15/2002 Read FDA Release) FDA OFFICE OF WOMEN'S HEALTH LAUNCHES "TAKE TIME TO CARE…ABOUT DIABETES" CAMPAIGN - 05/02/2002 Read FDA Release HHS, ADA WARN AMERICANS OF "PRE-DIABETES," ENCOURAGE PEOPLE TO TAKE HEALTHY STEPS TO REDUCE RISKS - Updated Statistics Show 17 Million with Diabetes, 16 Million More With Pre-Diabetes - HHS Secretary Tommy G. Thompson today warned Americans of the risks of "pre-diabetes," a condition affecting nearly 16 million Americans that sharply raises the risk for developing type 2 diabetes and increases the risk of heart disease by 50 percent. 03/22/2002 Read FDA Release NEW PRODUCT ALERT - FDA APPROVES NEW PORTABLE INSULIN-NEEDLE DESTRUCTION DEVICE FOR USE AT HOME BY PEOPLE WITH DIABETES - 03/15/2002 Read FDA Release Diabetes Headline News Resources
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