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Pramlintide approved for diabetes

United States of America - The Food and Drug Administration (FDA) has approved an injectable medicine, Pramlintide powder acetate (Symlin®), to control blood sugar for adults with type 1 and type 2 diabetes. Pramlintide, a synthetic analogue of the naturally occurring human hormone amylin, is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugar on intensive insulin therapy alone.

Pramlintide 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 pramlintide has been studied in approximately 5000 patients. Overall, pramlintide therapy was associated, in patients with both types of diabetes, with improvement in the control of blood glucose and 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.

Pramlintide is to be used only in combination with insulin to help lower blood sugar during the 3 hours after meals. pramlintide will have a Medication Guide (FDA-approved patient labelling) and a Risk Minimization Action Plan (RiskMAP) due to three areas of concern. First, the principle risk associated with pramlintide therapy is hypoglycaemia, 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 pramlintide with insulin in the same syringe, which can alter the activity of the insulin, is addressed in the Medication Guide and in physician labelling. 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.

Pramlintide 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 pramlintide include but are not limited to nausea, vomiting, abdominal pain, headache, fatigue and dizziness.

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