New Diabetes Drug Denied FDA Approval.... For Now.

It could be close to two years before Bydureon, a new diabetes drug whose approval was just rejected by the U.S. Food and Drug Administration (FDA), gets another shot at coming to market.

The drug, being developed by Amylin Pharmaceuticals and Eli Lilly, will need to undergo further testing, including a trial that looks for possible cardiac risks, before the FDA reconsiders its approval.

The drug, whose active ingredient — exenatide — comes from the saliva of the Gila monster, is a longer-lasting version of a similar drug already on the market, Byetta. Byetta is used to improve blood sugar control in people with type 2 diabetes, often in combination with other drugs.

While Byetta must be injected twice a day, Bydureon could be injected once a week.
However, if Byetta is any indication of the risks that lie ahead with Bydureon, the FDA made a wise choice in delaying its approval. Just two years ago, the FDA strengthened warnings on Byetta due to potentially life-threatening pancreas problems after two deaths and hospitalizations were reported.
Even Byetta’s Web site states that serious side effects “including inflammation of the pancreas (pancreatitis) which may be severe and lead to death” can occur in people who take the drug. Other known side effects include low blood sugar, kidney problems (including kidney failure that may require dialysis or kidney transplant), severe allergic reactions, vomiting, jittery feelings, acid stomach, headache and more.

There’s no telling which of these side effects, or others, may be associated with Bydureon as well if it ends up getting approved in 2012.

As always, it’s important to be well aware of the serious risks that come with taking medications for diabetes, and decide, along with your health care practitioner, if diet and lifestyle strategies could lead to similar improvements in your blood sugar control — without all the risks.
You’ll find that, often, a treatment plan individually tailored to your own underlying causative factors will resolve type 2 diabetes in a much safer, deeper and more effective way than drugs ever could.

NYTimes.com October 19, 2010
Yahoo News October 19, 2010

Corn Syrup May Soon Be Disguised On Food Labels

All the research linking high-fructose corn syrup (HFCS) to the epidemic rates of diabetes and obesity, not to mention metabolic syndrome, in the U.S. has many Americans ditching the sweetener in favor of healthier alternatives. Now, with consumption of the corn sweetener at a 20-year low, the Corn Refiners Association (CRA) is taking action to revamp their prized glory’s tarnished image.

Last month, CRA petitioned the U.S. Food and Drug Administration (FDA) to allow manufacturers the option of calling high-fructose corn syrup “corn sugar” on labels. The current name is “confusing to American consumers,” according to CRA, and labeling the sweetener as corn sugar “succinctly and accurately describes what this natural ingredient is and where it comes from — corn,” they noted.
But make no mistake, whether high-fructose corn syrup is rebranded as “corn sugar” or not, the fact still remains that it’s a substance you’re better off without.

Any type of sweetener can lead to insulin resistance, and later diabetes, when used in excess, which is why you should strive to keep high-fructose corn syrup, or corn sugar — or any sugar — to a minimum in your diet.

The FDA has six months to decide whether the term corn sugar will be allowed to stick around, and it could be another year or more after that before the term actually appears on food labels. The Corn Refiners Association, however, is not holding their breath … they’ve already started using the term in their extensive advertising campaigns.
PRNewsWire.com September 14, 2010
LiveScience.com September 14, 2010
NYTimes.com September 14, 2010