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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. December 2005 FDA Diabetes-Related Releases
November 2005 FDA Diabetes-Related Releases 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. Read full FDA release 11/16/2005 Diabetes 2, ACTOplus met™ (pioglitazone HCl and metformin HCl). 11/06/05 Phenergan can cause death in children under age 2. Drug Approved for Treatment of Iron Overload due to blood transfusions. November 4, 2005. 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 FDA alert - 11/04/2005 October 2005 FDA Diabetes-Related Releases Wall Street Journal Examines FDA Approval Process for Diabetes Drug. 10/30/05 Freestyle or other meter made by Abbott? Glucose Meter Warnings! 10/26/05 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 FDA release - 10/26/2005 September 2005 FDA Diabetes-Related Releases DiObex Receives Fast-Track Status from FDA for VLD-Glucagon. 09/28/05 FDA Approves Freestyle Connect™ Blood Glucose Monitoring System, Abbott. 09/22/05 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 FDA announcement - 09/09/2005 August 2005 FDA Diabetes-Related Releases 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 FDA announcement - 08/30/2005 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 FDA announcement - 08/30/2005 DANA Diabecare Warned by FDA for improper reporting when pump users seriously injured... 08/10/05; Also see: Dana Insulin Pumps Not Recalled 08/24/05 (related, 07/23/04 FDA Warning letter to Dana Diabecare) July 2005 FDA Diabetes-Related Releases Disetronic Medical Systems, Inc. Announces Recall
of Certain Adapters Used With the D-TRONplus Insulin Pump FDA Warns Against Use of Liqiang 4
Dietary Supplement June 2005 FDA Diabetes-Related Releases 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 - 06/14/2005 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. Entire FDA Public Message - 06/13/2005 May 2005 FDA Diabetes-Related Releases 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 FDA release - 05/10/2005 April 2005 FDA Diabetes-Related Releases 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. Read full FDA release - 04/28/2005 March 2005 FDA Diabetes-Related Releases 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 FDA story - 03/17/2005 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 FDA release - 03/04/2005 February 2006 FDA Diabetes-Related Releases January 2005 FDA Diabetes-Related Releases 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 FDA story - 01/18/2005 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 FDA story - 01/12/2005 Diabetes Headline News Resources
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