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FDA Approves New Diabetes Drug Symlin

Injectable Drug Helps Control Blood Sugar in Type 1 and Type 2 Diabetes
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WebMD Health News

The FDA has approved a drug called Symlin to help control blood sugar in people with type 1 and type 2 diabetes who do not achieve good blood sugar control with insulin therapy.

Symlin, an injectable drug, is a manufactured version of human amylin, a hormone secreted along with insulin. Symlin is given at mealtimes and will not replace insulin. Instead, it is only to be used with insulin to help lower blood sugar during the three hours after meals, says the FDA.

Symlin is also not intended for everyone with diabetes, says the web site of the drug's maker. It's only for patients who are already using medicine as advised but still need more help to control blood sugar.

"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," says an FDA statement.

Symlin is made by Amylin, a San Diego biotech company. In January 2004, Amylin withdrew its application to sell Symlin in Switzerland when questions arose about side effects including nausea and hypoglycemia (low blood sugar). Both of those side effects are noted on the drug's labeling and medication guide.

Amylin has another diabetes drug, Exenatide, awaiting FDA approval. Late last year, John Buse, MD, PhD, told WebMD he expected Exenatide to be approved for type 2 diabetes. Buse directs the Diabetes Care Center at the University of North Carolina's medical school.

"So-called 'tight' control of blood sugar is desirable in all diabetes patients," says the FDA. Closely controlling blood sugar can help reduce risks of long-term problems tied to diabetes, including blindness, kidney disease, and heart disease.

Besides insulin, Symlin will be the only therapy for treating type 1 diabetes. Several oral medicines are already available for people with type 2 diabetes.

 

Candidates for Symlin

Symlin has not been evaluated for use by children. The FDA says the drug should only be used if patients:

  • Are already using their insulin as prescribed but still need better blood sugar control
  • Will follow their doctor's instructions exactly
  • Will follow up with their doctor often
  • Will test their blood sugar levels before and after every meal, and at bedtime
  • Understand how to adjust Symlin and insulin doses

Symlin should not be used if patients:

  • Can't tell when their blood sugar is low
  • Have a complication called gastroparesis, which slows the absorption of food and makes blood sugar control erratic
  • Are allergic to pramlinitide acetate, metacresol, D-mannitol, acetic acid, or sodium acetate

Symlin's safety and effectiveness were studied in about 5,000 patients. Overall, the drug was associated with improvements in blood sugar control and weight loss. Benefits were seen with both types of diabetes, says the FDA.

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If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

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