FDA Approves New Diabetes Drug Symlin

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

Medically Reviewed by Brunilda Nazario, MD on March 17, 2005
From the WebMD Archives

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.

According to Amylin, studies show that Symlin injections prior to meals help lower blood sugar after meals, leading to less fluctuation during the day and better long-term blood sugar control when compared with insulin alone.

"Side effects associated with Symlin included but are not limited to nausea, vomiting, abdominal pain, headache, fatigue, and dizziness," says the FDA.

The FDA notes three areas of concern that will appear in Symlin's labeling and medication guide:

Hypoglycemia (low blood sugar). This is the principle risk with Symlin therapy, says the FDA. Hypoglycemia risk was highest in people with type 1 diabetes and patients with gastroparesis.

Potential for medical error. Specifically, mixing Symlin with insulin in the same syringe can alter the activity of the insulin, says the FDA.

Potential for off-label use. The FDA voices concern about Symlin use by patients other than those who have been studied. The drug's maker, Amylin Pharmaceuticals, will monitor that, says the FDA.

Show Sources

SOURCES: FDA. WebMD Feature: "Health in 2005: What May Come." Amylin Pharmaceuticals. Reuters.

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