Posts Tagged ‘diabetics’

FDA Approves New Drug Treatment for Type 2 Diabetes

Tuesday, September 1st, 2009

The article below gives alternative treatment for Type-2 Diabetics:

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

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Technorati Tags: diet, exercise, health

Insulin patch for Diabetics

Friday, August 21st, 2009

For Diabetics who need to enure the pain and discipline required in the use or injection pens, the following article is nice to know…read more below…

Medingo’s insulin patch approved; shares rocket

By Nick Taylor, 30-Jul-2009

Medingo’s insulin dispensing patch has been approved by the US Food and Drug Administration (FDA), sending shares in its parent company soaring to a 12 month high.

The company claims the patch, called Solo, is the smallest, thinnest, lightest and most discrete insulin pump without cumbersome tubing. Solo consists of two components: an insulin dispensing patch and a remote control.

Using the remote patients can customise the patch’s output to match their insulin needs. Gaining approval for the patch is regarded as a major milestone by Arie Mientkavich, chairman of Medingo.

Solo is set to be showcased at the American Association of Diabetes Educators Meeting, which takes place in Atlanta, US in August 2009. Mientkavich said the Medingo is “currently considering alternatives for its go-to-market strategy and the timing of the product launch”.

Release of the news sent the share price of Medingo’s parent company, Elron Electronics Industries, up by 56.4 per cent. The rise demonstrates investors’ belief in the opportunities that exist for products that deliver insulin in a more convenient way.

Sustained growth

Approval of Medingo’s Solo patch coincided with the release of a report into the transdermal drug delivery market by Greystone Associates.

The report predicts a period of sustained growth for the transdermal drug delivery market and highlights some areas other than diabetes where the technology is effective.

In particular the report believes that transdermal patches will be useful for the elderly, who tend to be less able to self-medicate than other patients groups. The aging population means that this will provide an increasingly large market.

To achieve a sustainable growth model, which the report says has so far eluded the transdermal delivery sector, Greystone predicts companies will pursue two strategies.

Firstly companies will achieve growth by increasing market penetration in key transdermal therapeutic segments by refining product strategies. A second source of growth will come from companies seeking to extend product lifecycles in the face of patent expiration.

The report believes that growth can be achieved by expanding into new therapeutic areas and working with companies that market patent protected products.

Diabetics - If you are taking Levemir, take note

Sunday, August 9th, 2009

I saw this article, first published in June 13 2009 and felt it important to share….

FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.

For more information:
Novo Nordisk news release

Technorati Tags: health