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