|
Safety Alert about Byetta (exenatide) and Pancreatitis
Source: Exenatide (marketed as Byetta), FDA Information for Healthcare Professionals, August 18, 2008.
FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.
FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.
Read full release
Recall of all Lots of Viapro 375 mg Capsules
Source: EG Labs announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient, Firm Press Release, July 29, 2008.
EG Labs, LLC, announced that it is conducting a nationwide recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. Lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thiomethisosildenafil, an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance.
The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Read full release
Federal Authorities Seize Xiadafil VIP Tablets
Source: Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product, FDA Press Release, July 24, 2008.
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.
ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs.
Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.
Read full release
Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Source: Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient, Firm Press Release, July 28, 2008.
Jack Distribution, LLC, and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced that they are conducting a nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".
Chemical analysis revealed that Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Read full release
FDA Announces New Labeling Changes for Regranex
Source: FDA Announces New Labeling Changes for Regranex, FDA Press Release, June 6, 2008.
The U.S. Food and Drug Administration announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.
Read full release
Recall of Viril-ity-Power (VIP) Tabs
Source: International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement, Firm Press Release, May 29, 2008.
International Pharmaceuticals, Ltd. announced that it is conducting a recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.
Lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil. The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Read full release
FDA Reminds Glucose Meter Users to Only Use Strips Recommended For Their Meter
Source: Reminder: Users of Blood Glucose Meters Must Use Only the Test Strip Recommended For Use With Their Meter, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA, March 10, 2008.
It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results.
Users of blood glucose meters should carefully read the Owner’s Manual and only use the test strips that are specified for that meter. As an additional check, the test strip inserts identify the blood glucose meters with which they should be used.
Healthcare providers and pharmacists should advise their patients to use only test strips that are compatible with their meter.
Read full release
Recall of Aspire36 and Aspire Lite, Products Marketed as Dietary Supplements
Source: Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements, Firm Press Release, February 28, 2008.
Palo Alto Labs is conducting a nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite.
Lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil. This may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program.
Read full release
FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular
Source: FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) - These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs, FDA Press Release, December 28, 2007.
The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.
Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients. The products are thus drugs that are illegal. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
FDA advises consumers to discontinue use. Consumers should consult their health care providers if they have experienced any adverse events. Consumers and health care professionals can report adverse events to FDA's MedWatch program.
Read full release
FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia
Source: FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia - Agency says drug to remain on market, while safety assessment continues, FDA Press Release, November 14, 2007.
The U.S. Food and Drug Administration announced that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.
The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
Read full release
FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Supplements
Source: FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements, FDA Press Release, November 2, 2007.
The U.S. Food and Drug Administration requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products could interact with medications and cause dangerously low blood pressure.
As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil.
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin.
Read full release
Daylight Saving Time May Affect Your Medical Equipment
Source: Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way, Medical Device Safety Alert, March 1, 2007.
Medical equipment that uses, creates or records time information about your diagnosis or treatment may not work properly when the new Daylight Saving Time (DST) ends this year and in future years. If you experience a problem, it’s most likely to occur on the following dates:
* October 28 (Old date for end of DST)
* November 4 (New date for end of DST)
Check the time your equipment is displaying on October 28, 2007, and on November 4, 2007, to assure that it’s correct.
Read full release
Approximately $71,000 of Dietary Supplements Seized at FDA Request
Source: Approximately $71,000 of Dietary Supplements Seized at FDA Request - Products alleged to violate new drug and misbranding provisions of Federal Food, Drug and Cosmetic Act, FDA Press Release, October 12, 2007.
U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.
Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension.
FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.
Read full release
Users of Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® Blood Glucose Meters to Check Display Screens
Source: Urgent: Abbott Notifies Users of Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® Blood Glucose Meters to Check Display Screens, Firm Press Release, August 31, 2007.
Abbott is initiating a medical device correction for users of its Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters manufactured after January 31, 2007. If the meter is dropped on a hard surface, part or all of the display screen may not work properly or may appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results could result in significant risk for hypoglycemia or hyperglycemia.
Users of these meters who note that the display screen is not working properly should immediately stop using their meter and call Abbott Diabetes Care customer care for assistance at 1-877-844-4404. Customers may also call customer care if they have questions or need a replacement meter.
Read full release
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
Source: Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk - Companies Will Include Boxed Warning on Drug Label, FDA Press Release, August 14, 2007.
The U.S. Food and Drug Administration announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure. The information will be included in the form of a "boxed" warning—FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride).
The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.
Read full release
Recall of Bayer Ascensia® Contour® Blood Glucose Monitoring System
Source: Class 1 Recall: Bayer Ascensia® Contour® Blood Glucose Monitoring System, FDA Medical Device Recall Alert, July 13, 2007.
Bayer Healthcare LLC has recalled Bayer Ascensia® Contour® Blood Glucose Monitoring System, Product 7152A. The system consists of a meter, test strips contained in a dry (desiccated) bottle, a bottle of test solution, a lancing device and lancets, and instructions for use.
Serial numbers include: 1475139, 1688643, 1841620, 1852071,2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037, and 2319010.These meters were distributed from March 23, 2007 through May 31, 2007.
The meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Consumers may misinterpret the blood glucose results displayed by the meter and adjust treatment according to the misinterpreted result. They may overestimate the glucose value by 18 times what they actually are and over treat themselves.
Consumers may call Bayer Healthcare at 1-574-256-3441. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Read full notice
Recall of “Long Weekend” Dietary Supplement
Source: Confidence, Inc. Issues a Voluntary Nationwide Recall of all lots of Long Weekend, a Product Marketed as a Dietary Supplement, Firm Press Release, June 14, 2007.
Confidence, Inc. is conducting a voluntary nationwide recall of the product sold under the name Long Weekend. Lab analysis of Long Weekend samples found that the product contains undeclared tadalafil. FDA advises that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers should discontinue use of Long Weekend and consult their health care professional. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Read full release
FDA Approves Continuous 7-Day Glucose Monitoring System
Source: FDA Approves Continuous 7-Day Glucose Monitoring System, FDA Press Release, June 4, 2007.
The U.S. Food and Drug Administration approved a device that measures glucose levels continuously for up to seven days in people with diabetes.
The STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.
Read full release
FDA Issues Safety Alert on Avandia
Source: FDA Issues Safety Alert on Avandia, FDA Press Release, May 21, 2007.
The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
Read full release
Health Risk Alert for 'True Man' and 'Energy Max' Products
Source: FDA Issues Health Risk Alert for 'True Man' and 'Energy Max' Products, FDA Press Release, May 10, 2007.
The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products are illegal drug products that contain potentially harmful, undeclared ingredients.
The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers should discontinue use of True Man and Energy Max and consult their health care professional.
Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program.
Read full release
Recall of V.MAX Dietary Supplement
Source: Barodon SF Issues A Voluntary Nationwide Recall of V.MAX, a Product Marketed as Dietary Supplement, Firm Press Release, March 15, 2007.
Barodon SF, announced that it is conducting a nationwide recall of the supplement product sold under the name V.MAX. Lab analysis by FDA of V.MAX samples found the product contains Aminotadalafil, an analogue of Tadalafil. FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have V.MAX in their possession should stop use immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away.
Read full release
Recall of Rhino Max (Rhino V Max) Dietary Supplement
Source: Cosmos Trading, Inc. Issues Voluntary Nationwide Recall of Rhino Max (Rhino V Max), a Product Marketed as a Dietary Supplement, Firm Press Release, March 16, 2007.
Cosmos Trading, Inc., announced that it is conducting a nationwide recall of the supplement product sold under the name Rhino Max (Rhino V Max). Lab analysis by FDA of Rhino Max (Rhino V Max) samples found the product contains Aminotadalafil, an analogue of Tadalafil. FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
Read full release
Increased Incidence of Fractures in Females Taking Pioglitazone
Source: Actos (pioglitazone) Tablets; ACTOplus met (pioglitazone and metformin hydrochloride) Tablets; Duetact (pioglitazone and glimepiride) Tablets, MedWatch Safety Information Alert, March 9, 2007.
An analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a placebo or other drug. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.
Read full release
Daylight Saving Time May Affect Your Medical Equipment
Source: Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way, Medical Device Safety Alert, March 1, 2007.
Medical equipment that uses, creates or records time information about your diagnosis or treatment may not work properly when the new Daylight Saving Time (DST) starts and ends this year and in future years. If you experience a problem, it’s most likely to occur on the following dates:
- March 11 (New date for start of DST)
- April 1 (Old date for start of DST)
- October 28 (Old date for end of DST)
- November 4 (New date for end of DST)
If you are a patient or caregiver, look at your medical equipment and its instructions to see whether it uses or displays time. If so, contact the manufacturer of the equipment and find out if it needs any software or other patch or fix so it will continue to operate correctly when daylight savings time becomes effective on March 11, 2007.
Check your medical equipment after 2:00 AM on March 11, 2007, and after 2:00 AM on April 1, 2007, to make sure it displays the correct time before you rely on it. If your medical equipment displays or uses the incorrect time, tell the manufacturer about your equipment and ask your doctor before you use it.
Remember to check the time your equipment is displaying on October 28, 2007, and on November 4, 2007, to assure that it’s correct.
Read full release
Updates on Counterfeit One Touch Blood Glucose Test Strips
Source: FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips – Actions Constitute a Class I Recall , FDA Press Release, December 15, 2006.
The U.S. Food and Drug Administration (FDA) is providing an update to its notifications on October 13, and October 23, 2006, alerting the public to counterfeit blood glucose test strips being sold in the US for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. This update includes an additional lot number that is being distributed, along with a description of how to identify the new lot.
FDA has classified the current situation as a Class I recall because some of the counterfeit products have significant deviations in performance. The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.
The counterfeit test strips are:
- 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.
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact LifeScan, Inc. at 1-866-621-4855. Consumers who have discarded the outer box or do not know the lot number of their test strips should stop using those test strips and replace them.
Read full release
FDA Warns of Counterfeit 'One Touch' Glucose Strips
Source: FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips , FDA Press Release, October 23, 2006.
On October 13, 2006, the U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. This announcement provides two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.
The counterfeit test strips are:
- One Touch Basic®/Profile® (lot #272894A, 2619932, 2606340, and 2615211 (new) ) test strips; and,
- One Touch Ultra® (lot #2691191 and 2691261 (new) ) test strips.
The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact Lifescan, Inc. at 1-866-621-4855. Consumers who have discarded the outer box or do not know the lot number of their test strips should stop using those test strips and replace them.
Read full release
FDA, FTC Move to Stop Fraudulent Web Marketing of Diabetes Treatments:
Source: FTC and FDA Act Against Internet Vendors of Fraudulent Diabetes Cures and Treatments - Measures are Part of Coordinated Effort by United States, Mexico and Canada, FDA Press Release, (October 19, 2006.)
The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA), working with government agencies in Mexico and Canada, have launched a drive to stop deceptive Internet advertisements and sales of products misrepresented as cures or treatments for diabetes. The ongoing joint campaign has so far included approximately 180 warning letters and other advisories sent to online outlets in the three countries.
FDA announced it has issued warning letters to 24 firms marketing dietary supplement products with claims to treat, cure, prevent or mitigate diabetes. The FDA letters warn firms that failure to promptly correct the violations may result in enforcement action without further notice, which may include seizure of violative products and/or injunctions against the manufacturers and distributors.
Read full release
FDA Approves New Treatment for Diabetes
Source: FDA Approves New Treatment for Diabetes - First in a New Class of Diabetes Drugs, FDA Press Release, October 17, 2006.
The Food and Drug Administration (FDA) announced the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.
FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.
Read full release
Disetronic Medical Systems Inc. Recalls Power Packs used in D-TRONplus Insulin Pumps
Source: Disetronic Medical Systems Inc Announces a Voluntary Nationwide Recall of Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps , Firm Press Release, July 13, 2006.
Disetronic Medical Systems Inc. (Disetronic) of Fishers, IN announced a recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the real potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death. This is an Urgent Device Correction notification to health care professionals and their patients not requiring product removal at this time.
If you are a physician or a patient who has experienced a problem with any Disetronic D-TRONplus Power Packs, please notify Disetronic at 1-800-688-4578.
Read full release
Boca Medical Products Recalls Insulin Syringes
Source: Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product, Firm Press Release, April 13, 2006.
Boca Medical Products, Inc. is initiating a recall of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case. The product is being recalled because of possible bacterial presence of Bacillus cereus and Staphylococcus intermedius. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organism into previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels.
Consumers who have Ultilet Syringe Insulin product lot 5GEXI, should stop usage and return the specific product. For any question related to the case consumers should call 1-800-354-8460.
Read full release
Disetronic Medical Systems, Inc. Announces a Recall Of All ACCU-CHEK™ Ultraflex Infusion Sets
Source: Disetronic Medical Systems, Inc. Announces a Voluntary Nationwide Recall Of All ACCU-CHEK™ Ultraflex Infusion Sets, Firm Press Release, April 3, 2006.
Disetronic Medical Systems, Inc, (Disetronic) announced a voluntary nationwide recall of all ACCU-CHEK™ Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.
This recall applies to all ACCU-CHEK™ Ultraflex infusion sets. Patients using any standard luer-lock insulin pump may also be using these ACCU-CHEK™ Ultraflex infusion sets. Disetronic is advising customers to check their infusion sets at the luer lock-tubing connection at least every 3 hours and before bedtime. Customers also have the option of replacing their ACCU-CHEK™ Ultraflex infusion sets with ACCU-CHEK™ Tender, or ACCU-CHEK™ Rapid-D infusion sets.
Customers that have fully or partially separated tubing sets, or wish to discontinue use of their ACCU-CHEK Ultraflex Infusion Set may call Disetronic Medical Systems Pump Support at 1-800-688-4578 for replacement.
Read full release
FDA Approves Inhaled Insulin for Treatment of Diabetes
Source: FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes, FDA Press Release, January 27, 2006.
The Food and Drug Administration has approved the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s.
The safety and efficacy of Exubera have been studied in approximately 2500 adult patients with type 1 and type 2 diabetes. In clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by an injection. In type 1 diabetes, inhaled insulin may be added to longer acting insulins as a replacement for short-acting insulin taken with meals. In type 2 diabetes, inhaled insulin may be used alone, along with oral (non-insulin) pills that control blood sugar, or with longer acting insulins.
Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6 months). Exubera is not recommended in patients with asthma, bronchitis, or emphysema.
Read full release
Roche Diagnostics Issues a Recall of Some
ACCU-CHEK® Aviva
Meters
Source: Roche Diagnostics Issues a Worldwide Voluntary
Recall of Some of its ACCU-CHEK® Aviva Meters , Firm Press Release
, January 16, 2006 .
Roche Diagnostics has initiated a worldwide voluntary recall of specific
ACCU-CHEK Aviva Meters because of the potential for an electronic malfunction
which can cause the meter to report an erroneous result or shut down
and no longer be used.
The recall includes U.S. serial numbers 52500000000 through 52510999999.
In the U.S. people with diabetes, health care professionals, pharmacists,
and distributors have been instructed that if they have a meter with
these serial numbers, they should contact 1-888-591-5084 for a product
replacement. The recall does not apply to meters with U.S. serial numbers
52511000000 and higher or ACCU-CHEK Aviva test strips.
Outside the U.S. , the recall includes serial numbers 52600000000 through
52610999999, 52700000000 through 52710999999, and 52800000000 through
52810999999. Customers outside the U.S. have also been notified.
Read full release
Novartis Nutrition Corporation Issues Nationwide
Recall of Diabetisource® AC Product
Source: Novartis Nutrition Corporation Issues Nationwide Recall of
One Lot of its Diabetisource® AC Product, Firm Press Release, November
16, 2005.
Novartis Nutrition Corporation is recalling 2,712 bottles of an enteral
feeding formula which was incorrectly labeled as Diabetisource®
AC 1.5 Liter bottles lot 2135L. The product contained in these bottles
is Resource Diabetic® TF a tube feeding formulated for diabetes
which contains sodium and calcium caseinate, components of milk. People
with an allergy or severe sensitivity to milk run the risk of a serious
or life threatening allergic reaction if they consume this product.
In addition the two products are not nutritionally equivalent.
Healthcare professionals administering to patients who have an allergy
or sensitivity to milk should immediately stop using this product. Healthcare
institutions that have received shipping cartons labeled Resource Diabetic®
TF lot number 2135L or bottles labeled Diabetisource® AC 1.5 Liter
bottles lot 2135L should contact Novartis Customer Services at 1-800-333-3785.
Consumers who have questions can contact this same 800 number.
Read
full release
Recall of Abbott Blood Glucose
Meters
Source: Class I Recall: Abbott Blood Glucose Meters, Medical Device Recall,
November 4, 2005
Certain Abbott Diabetes Care, Inc. blood glucose meters can inadvertently
switch the readings from mg/dL, the U.S. standard to mmol/L, the foreign
standard. These include certain models of FreeStyle FLASH, Tracker,
Xceed, ReliOn, Kroger, RiteAid, Liberty, Boots, Optium, Xtra Classic,
Easy, SofTrac, and FreeStyle Glucose Monitoring Systems.
The recall was initiated on June 7, 2005. FDA announced a Class I recall
alert on November 4, 2005.
Consumers using Abbott Diabetes Care blood glucose meters should verify
that their meter is displaying the correct unit of measure each time
they test. If a recalled meter cannot be reset to the correct unit of
measure, consumers may contact Abbott Diabetes Care to request a replacement.
Read full alert
Important Safety Information
on Blood Glucose Meters
Source: FDA Provides Important Safety Information on Blood Glucose Meters,
FDA Press Release, October 26, 2005
The U.S. Food and Drug Administration (FDA) is notifying health care
providers and patients of a problem with blood glucose meters made by
Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally
be switched from one unit of measurement to another, resulting in an
inaccurate blood glucose interpretation by the user. Users in the United
States should make sure that their meter reading is displayed as mg/dL
because an inaccurate reading can lead to taking the wrong dose of insulin
or dietary changes, resulting in higher levels of sugar in the blood
or hyperglycemia.
The affected glucose meters that are sold in the United States are
FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense,
Sof-Tact, Precision Sof-Tact, MediSense, Optium, and private label brands
ReliOn Ultima, Rite Aid, and Kroger blood glucose meters.
Read full release
Insulin safety and storage
for people in the area hit by Hurricane Katrina
Source: Information Regarding Insulin Storage and Switching Between Products
by Victims of Hurricane Katrina, September 9, 2005
Diabetes patients in the Katrina area may not have been able to refrigerate
their insulin. Product labels from all three U.S. manufacturers recommend
that insulin be refrigerated. But the available insulin products may
be left un-refrigerated – at up to 86 degrees for up to 28 days
– and still maintain potency.
In general, insulin loses its strength as its temperature rises and
depending on how long it is exposed. Patients may still need to use
available insulin even though storage temperatures exceeded 86 degrees.
But the temperatures may make the insulin less potent, and this could
result in loss of blood glucose control over time.
Insulin from various manufacturers is being made available. Patients
who get this insulin should discard older supplies that had not been
properly refrigerated.
Read full announcement
Drug Use and Safety in the
Aftermath of Hurricane Katrina
Source: FDA Offers Valuable Information about Drug Use and Safety in the
Aftermath of Hurricane Katrina, August 30, 2005
Drugs that have been exposed to flood or unsafe municipal water may
become contaminated. This contamination may lead to diseases that can
cause serious health effects.
Ideally, these exposed products – even in their original containers
– should be discarded. But in many situations, these drugs may
be lifesaving and replacements may not be readily available. For life-saving
drugs, if the container is contaminated but the contents appear unaffected
– for instance, if the pills are dry -- the pills may be used
until they can be replaced. If they are wet, they are contaminated and
should be discarded.
If a contaminated product is medically necessary and can’t be
replaced quickly, contact a healthcare provider – for example,
the Red Cross, a hospital, or an emergency medical facility –
for guidance.
Read full announcement
Special Information about
Using Blood Glucose Meters after Hurricane Disasters
Source: FDA Offers Tips about Medical Devices and Hurricane Disasters,
August 30, 2005
Heat and humidity can damage blood glucose meters and test strips.
If you use a blood glucose meter, check the meter and test strip package
insert for information on use during unusual heat and humidity. Store
and handle the meter and test strips according to the instructions.
Perform quality-control checks to make sure that your home glucose testing
is accurate and reliable.
Read full announcement
Disetronic Medical Systems, Inc. Announces
Recall of Certain Adapters Used With the D-TRONplus Insulin Pump
Source: Disetronic Medical Systems, Inc. Announces a Voluntary Recall
of the D-TRON Adapters, Used With the D-TRONplus Insulin Pump, Firm Press
Release, July 29, 2005
Disetronic Medical Systems, Inc., Fishers, Indiana is announcing a
voluntary nationwide recall of its D-TRON adapters, used with the D-TRONplus
insulin pump, because they can potentially over-deliver a maximum amount
of up to 1.8 I.U. of insulin. Use of these recalled adapters may pose
a potential life-threatening situation to certain children using the
pump. Other users who are insulin sensitive may also be at increased
risk. The affected D-TRON adapters are part number REF 3000803, Lots
4013674 through 4022628. Other adapter lots are not affected.
Read
full release
FDA Warns Against Use of Liqiang
4 Dietary Supplement
Source: FDA Issues Nationwide Alert for "Liqiang 4" Due to Potential
Health Risk, FDA Talk Paper, July 1, 2005
The U.S. Food and Drug Administration (FDA) is warning consumers not
to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide
– a drug that could have serious, life-threatening consequences
in some people.
Glyburide is a drug used to lower blood sugar, and is safe and effective
when used as labeled in FDA-approved medications. People who have low
blood sugar or those with diabetes can receive dangerously high amounts
of glyburide by consuming Liqiang 4. Consumers should immediately stop
using these products and seek medical attention, especially if they
are currently being treated with diabetes drugs or if they have symptoms
of fatigue, excessive hunger, profuse sweating, or numbness of the extremities.
Consumers who have this product should dispose of it immediately.
Read full release
Qualitest Pharmaceuticals Recalls Accusure
1 cc Insulin Syringes
Source: Qualitest Pharmaceuticals, Inc. Issues a Voluntary Nationwide
Recall of Accusure Insulin Syringes 1cc 28 Gauge 1/2 Inch 100's, Firm
Press Release, June 14, 2005
Qualitest Pharmaceuticals, Inc., has issued a voluntary nationwide
recall of Accusure Insulin Syringes 1cc, 28 Gauge l/2 Inch, distributed
between October 2004 and June 2005. There may be 1cc syringes which
are mislabeled as 1/2 cc syringes on the plastic inner wrap holding
10 individual syringes, which could potentially result in confusion
by the patient or caregiver, resulting in an incorrect dose or amount
being administered.
Read
full Press Release
FDA Issues a Public Message
on LifeScan Blood Glucose Meters
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH,
FDA, June 13, 2005
In a Public Message the FDA stated that LifeScan has notified users
of some of the company's blood glucose monitoring systems that it may
be possible for them to misinterpret their blood glucose test results
if their meter is set incorrectly. The affected meters are the OneTouch®
Ultra®, the OneTouch® FastTake® and the InDuo® Systems.
These meters were originally designed to allow the patient to select
one of two units of measure to display their blood glucose results:
milligrams per deciliter (mg/dL), the standard used in the U.S., and
millimoles per liter (mmol/L), which is used in many other countries.
This feature allows patients to see their test results in the units
customarily used in their own country. Meters with this same feature
are also made by other companies.
LifeScan found that it was possible for patients, in the course of
setting the meter’s date and time, to accidentally change the
unit of measure. If the meter is in the wrong units of measure and the
patient looks only at the result registered on the meter, without reading
the measurement unit displayed next to the result, he or she could misunderstand
the test result. This could lead to the patient managing his or her
diet or medication in a way that could result in temporary periods of
high or low blood sugar, which may require medical intervention.
For additional information on this public notice, see the entire
Public Message by the FDA.
LifeScan, Inc. Announces
Worldwide Correction Concerning Certain Blood Glucose Meters
Source: LifeScan, Inc. Announces Worldwide Correction Concerning Certain
Blood Glucose Meters , Firm Safety Alert, May 10, 2005
LifeScan, Inc, a maker of blood glucose testing systems for people
with diabetes, is initiating a worldwide notification to all users of
its OneTouch® Ultra®, InDuo® and OneTouch® FastTake®
Meters that it may be possible for users to misinterpret their blood
glucose results. All three affected meter systems were originally designed
to allow patients to select one of two units of measure to display their
test results. This selection is typically determined by the standard
used by the country in which they live. LifeScan, Inc., found that it
was possible for consumers, in the course of setting their meter's date
and time, to accidentally change the unit of measure and thereby misinterpret
their blood glucose results.
In addition, very rarely, an event such as dropping a meter while
in use can cause a brief power loss, which may also unexpectedly change
the unit of measure and/or the code number used to program the meter
to match a particular vial of test strips. Shipments of test strips
for these systems are not affected.
Users should continue to test their blood glucose. LifeScan, Inc., is
instructing patients to confirm their meter's unit of measure and the
code number each time they test.
Read full
release
GlaxoSmithKline
Signs Consent Decree Agreeing to Fix Manufacturing Problems
Source: GlaxoSmithKline Signs Consent Decree with FDA; Agrees to Correct
Manufacturing Deficiencies, FDA Press Release, April 28, 2005
The U.S. Food and Drug Administration (FDA) announced
that GlaxoSmithKline, Inc. (GSK), (through its U.S. subsidiaries SB
Pharmco Puerto Rico, Inc., GlaxoSmithKline Puerto Rico Inc., and SmithKline
Beecham Corporation), has signed a consent decree with FDA to correct
manufacturing deficiencies at its Cidra, Puerto Rico facility. FDA is
concerned that GSK's violation of manufacturing standards may have resulted
in the production of drug products that could potentially pose risks
to consumers.
FDA found that some Avandamet tablets, used to treat
Type II diabetes, did not have an accurate dose of rosiglitazone, an
active ingredient in this product. However, the FDA urges patients who
use this drug to continue taking their medication and to talk with their
health care provider about possible alternative products until the manufacturing
issues have been resolved.
Under the terms of this decree the company has agreed
to take measures to ensure that its Cidra facility and the two drugs,
Paxil CR and Avandamet, fully comply with current Good Manufacturing
Practice ( cGMP) requirements and to ensure that ongoing shipments have
the quality attributes they are required to possess. The decree also
requires that all corrections and the firm's compliance with cGMP requirements
be certified by a third-party expert. Additionally, FDA will continue
to monitor these activities through its inspections.
Read
full release
FDA Approves New Drug to Treat
Type I and Type II Diabetes
Source: FDA Approves New Drug to Treat Type I and Type II Diabetes, FDA
Talk Paper, March 17, 2005
The Food and Drug Administration (FDA) today approved Symlin, an injectable
medicine to control blood sugar for adults with type 1 and type 2 diabetes.
Symlin is to be used in addition to insulin therapy in patients who
cannot achieve adequate control of their blood sugars on intensive insulin
therapy alone. Symlin has not been evaluated in the pediatric population.
Read
full story
Manufacturing
Violations Prompt Seizure of Diabetes Drug Avandamet
Source: U.S. Marshals Seize Lots of GlaxoSmithKline's Paxil CR and Avandamet
Tablets Because of Continuing Good Manufacturing Practice Violations,
FDA Press Release, March 4, 2005
In a response to ongoing concerns about manufacturing quality, the
Food and Drug Administration (FDA) and the Department of Justice initiated
a seizure of Avandamet tablets manufactured by GlaxoSmithKline, Inc.
(GSK). Manufacturing practices for Avandamet, approved to treat Type
II Diabetes, failed to meet the standards laid out by FDA that ensure
product safety, strength, quality and purity.
FDA is not aware of any harm to consumers by the product subject to
this seizure and it does not believe that this product poses a significant
health hazard to consumers. Consequently, FDA urges patients who use
this drug to continue taking their tablets and to talk with their health
care provider about possible alternative products for use until the
manufacturing problems have been corrected.
Read full release
New Awareness
Campaign for Older Adults
Source: Lifestyle Changes Especially Effective at Preventing Type 2 Diabetes
in Adults Aged 60 and Older, NIH/NIDDK Press Release, January 18, 2005
To spread the word that diabetes prevention for older adults is proven
and possible, the U.S. Department of Health and Human Services’
(HHS) National Diabetes Education Program (NDEP) has launched a public
awareness campaign called “It’s Not Too Late to Prevent
Diabetes. Take Your First Step Today”. The campaign delivers the
message that type 2 diabetes can be prevented or delayed.
Read
full story
New Dietary
Guidelines for Americans
Source: New Dietary Guidelines Will Help Americans Make Better Food Choices,
Live Healthier Lives, DHHS Press Release, January 12, 2005
HHS Secretary Tommy G. Thompson and Agriculture Secretary Ann M. Veneman
announced the release of the Dietary Guidelines for Americans 2005,
the federal government's science-based advice to promote health and
reduce risk of chronic diseases through nutrition and physical activity.
Read
full story
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 story
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 story
Family History Initiative
website
HHS Statement on Institute of Medicine Report on
Childhood Obesity
Source: Statement by Tommy G. Thompson, Secretary of Health and Human
Services Regarding Institute of Medicine Report on Childhood Obesity,
DHHS Press Release, September 30, 2004
“The Institute of Medicine (IOM) report on childhood obesity
makes clear that the fight against obesity begins at home. That is why
we must continue to bring together industry, schools and the government
to help parents create an environment that allows their families to
make healthy eating and exercise choices. We at HHS are determined to
do our part.”
Read
full report
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 report
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 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 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 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 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 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 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 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 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 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 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 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 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 report
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 Dear Healthcare
Provider Letter
FDA Clears Home Glycated Hemoglobin Test For Diabetics
(December 17, 2002)
(continue)
FDA Approves GlucoWatch for Children With Diabetes
(August 27, 2002)
(continue)
NEW PRODUCT!
(June 24, 2002)
FDA CLEARS NEW PALM TEST FOR SKIN CHOLESTEROL
(continue)
NEW PRODUCT!
(June 13, 2002)
FDA CLEARS TWO GLUCOSE TEST METERS
FDA has cleared for marketing two glucose test meters used with personal
digital assistants (PDAs).
(continue)
(May 15, 2002)
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).
(continue)
(May 2, 2002)
FDA OFFICE OF WOMEN'S HEALTH LAUNCHES "TAKE TIME TO CARE…ABOUT
DIABETES" CAMPAIGN
(continue)
(March 22, 2002)
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.
(continue)
NEW PRODUCT!
(March 15, 2002)
FDA APPROVES NEW PORTABLE INSULIN-NEEDLE DESTRUCTION DEVICE FOR USE
AT HOME BY PEOPLE WITH DIABETES
(continue)
Important
Message
PEOPLE WITH DIABETES SHOULD AVOID EATING RAW OYSTERS OR CLAMS
(posted May 28, 2002)
(continue)
(back)
Updated August 25, 2008 |
