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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. July 2007 FDA Diabetes-Related Releases June 2007 FDA Diabetes-Related Releases 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. Read full FDA 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 FDA full release - 06/04/2007 May 2007 FDA Diabetes-Related Releases 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 FDA release - 05/21/2007 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 FDA release - 05/10/2007 April 2007 FDA Diabetes-Related Releases Daylight Savings Time May Affect Your Medical Equipment - Source: Advice for Patients: Change in Daylight Savings 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 Savings 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:
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 FDA release - March 1, 2007 March 2007 FDA Diabetes-Related Releases 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 FDA release - 03/16/2007 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 FDA release - 03/15/2007 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 FDA release - 03/09/2007 February 2007 FDA Diabetes-Related Releases January 2007 FDA Diabetes-Related Releases Diabetes Headline News Resources
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