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The Food and Drug Administration (FDA)
today approved Symlin, an injectable medicine to control blood sugar
for adults with type 1 and type 2 diabetes. 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.
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Symlin will
be the only therapy for the treatment of type 1 diabetes other than
insulin. Patients with type 2 diabetes already have several other
types of oral therapies available.
The safety
and efficacy of Symlin were studied in approximately 5000 patients.
Overall Symlin therapy was associated, in patients with both types
of diabetes, with improvements in the control of blood glucose and
with weight loss. So-called "tight" control of blood sugar is
desirable in all patients with diabetes in order to reduce risks for
long-term adverse consequences of the disease, including blindness,
kidney disease, and vascular disease.
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Symlin is
to be used only in combination with insulin to help lower blood
sugar during the 3 hours after meals. Symlin will have a Medication
Guide (FDA-approved patient labeling) and a Risk Minimization Action
Plan (RiskMAP) due to three areas of concern. First, the principle
risk associated with Symlin therapy is hypoglycemia, and this risk
is greatest in patients with type 1 diabetes and in patients with
gastroparesis (motility problems of the stomach-a long-term
complication of diabetes). Second, the potential for medication
errors, specifically mixing of Symlin with insulin in the same
syringe, which can alter the activity of the insulin, is addressed
in the Medication Guide and in physician labeling. Finally, the
potential for off-label use in patients where the benefit/risk
profile has not been characterized or demonstrated is also a concern
and will be monitored by the sponsor.
The
Medication Guide informs patients that Symlin should only be used if
they 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; and
understand how to adjust Symlin and insulin doses.
Symlin
should not be used if patients cannot tell when their blood sugar is
low, have gastroparesis (slow stomach emptying), or are allergic to
pramlintide acetate, metacresol, D-mannitol, acetic acid, or sodium
acetate.
Side
effects associated with Symlin include but are not limited to
nausea, vomiting, abdominal pain, headache, fatigue and dizziness.
Symlin has
not been evaluated in the pediatric population.
Symlin is
manufactured by Amylin Pharmaceuticals, Inc. of San Diego,
California. |
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