FDA approves new diabetes drug
Thursday, March 17th 2005, 1:14 pm
By: News On 6
WASHINGTON (AP) _ A new drug for diabetics who can't adequately control their blood sugar with insulin was approved by the Food and Drug Administration on Thursday.
The FDA said the drug, Symlin, is intended for use in addition to insulin in patients with either type 1 or type 2 diabetes.
Symlin, made by Amylin Pharmaceuticals, Inc. of San Diego, Calif., is intended only to be used, in combination with insulin, to help lower blood sugar during the three hours after meals, FDA said.
The agency said the primary risk associated with Symlin therapy is low blood sugar, and this risk is greatest in patients with type 1 diabetes and in patients with stomach problems.
Side effects associated with Symlin included nausea, vomiting, abdominal pain, headache, fatigue and dizziness.
The FDA warned against mixing Symlin with insulin in the same syringe, which can alter the activity of the insulin.
It said the drug has not been tested for use in children.
FDA said the drug will come with a medication guide that advises patients that Symlin should only be used if they are already using their insulin as prescribed, but still need better blood sugar control. It also must advise that individuals follow their doctor's instructions exactly, follow-up with their doctor often, l test their blood sugar levels before and after every meal and at bedtime, and understand how to adjust Symlin and insulin doses.