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FDA Approves Symlin Pen, But Forbids Symlin Use Without Bolus Insulin


Nov 14, 2007

The Food and Drug Administration (FDA) just approved pre-filled pens for administering Symlin, which was previously available only in vials. The SymlinPen 60 delivers 15, 30, 45, or 60 micrograms per dose.

The SymlinPen 120 delivers 60 or 120 micrograms per dose. Both may be stored at room temperature, up to 86 degrees, after first use.

The FDA also issued a "Not Approvable" letter forbidding the use of Symlin in patients with type 2 who are using basal insulin but are not using meal-time, or bolus, insulin. Symlin is approved for use only in type 1s or type 2s who are using meal-time boluses and need more help with their blood sugar control.

Source: Amylin Press Release, September 2007


Categories: Blood Sugar, Food, Insulin, Insulin Pumps, Medications, Pens, Symlin, Type 1 Issues, Type 2 Issues



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Comments

Posted by Anonymous on 15 November 2007

I prefer NOT to inject Gila Monster spit, thank you very much!

Posted by Anonymous on 15 November 2007

Symlin is not from Gila Monster. Actually Byetta is not the Gila Monster spit but a synthesised protein called exemtide or something like that. Byetta often reverses the symptoms of Diabetes in Type 2 patients who are not in good control on Diabetic Meds alone. So maybe you ought to rethink your premise.

Posted by Ballot on 15 November 2007

Symlin is not made from Gila Monster spit as far as I know. It has just been announced today that in recent controlled tests that Symlin and Leptin have shown a 12.05% loss in weight over an 18 week period. This is remarkable and the first time a diabetic drug has posted this kind of results with non diabetics. It will be a block buster for Amylin eventually. With symlin now in a pen it will be used by many more persons. It is a health thing and now is the time for all of us.

Posted by Anonymous on 15 November 2007

I am happy! I stopped using symlin only because going back to carrying syringes and a vial felt like going back 20 years. I started pumping in 1987-88.

Posted by Anonymous on 18 November 2007

I tried Symlin many months ago, but I quit using it for the same reason I would always skip my insulin until I started pumping. I really hate giving shots and carring all that stuff with me. I can not wait to use the pen and see if my sugar and WEIGHT gets better again.

Posted by Anonymous on 20 November 2007

Typical FDA overprotectiveness. They are "worried" that Symlin would be taken to help a Type 2 lose weight (that is, they are protecting the diet food industry). The fact that Symlin would be taken without a bolus would actually be beneficial since it would reduce the most serious of the drug's side effects--hypoglycemia. FDA Idiots!

Posted by Anonymous on 29 November 2007

Symlin is a synthetic version of the pancreatic beta cell hormone called amylin which is completely absent in all patients with type 1 diabetes. It is in no way a weight loss drug. Although some patients report a very small weight loss, some doctors have speculated that the primary reason for this is because insulin requirements drop and calorie consumption is reduced. But the average weight loss in clinical trials was pretty marginal, in both patients with type 1 as well as those with type 2 diabetes, although type 2s lost more weight on average because they had a higher BMI on average to begin with.

Posted by Anonymous on 16 July 2008

I started using symlin and I am having good results with it. I also used byetta with good results. I suggest anyone having problems should try either of them. Thankyou

Posted by Anonymous on 29 April 2011

I disagree with one of the comments. Symlin, if used under the direction of a doctor, is a great weight loss tool. I have lost over 18 pounds in the past 30 days using it. I don't have diabetes,


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