FDA Approves New Diabetes Drug Symlin
Injectable Drug Helps Control Blood Sugar in Type 1 and Type 2 Diabetes
Candidates for Symlin continued...
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.