Januvia Okayed for Use With Sulfonylureas
Januvia, also known as sitagliptin phosphate, is a DPP-IV inhibitor. It prevents, or inhibits, DPP-IV from inactivating GLP-1. GLP-1 is a naturally produced hormone that increases insulin secretion in response to food.
Unfortunately, it disappears rapidly from the body because DPP-IV breaks it down. We want to keep it around, and that's why a DPP-IV inhibitor like Januvia is helpful in controlling diabetes. (See "The Incretin Saga: Mimetics, Enhancers, and Inhibitors" for a primer on how this all works.)
Januvia was approved last year for use by itself and for adding to metformin or the thiazolidinediones (Actos and Avandia) if those weren't enough to do the job alone. Now the FDA has also approved Januvia as an initial therapy with metformin and as an add-on to sulfonylureas or to a combination of both a sulfonylurea and metformin when those two drugs aren't providing adequate control.
Januvia's manufacturer, Merck, also updated the drug's Warning and Precautions label to advise patients to stop taking Januvia if they develop an allergic reaction. The bolstered warning was based upon reports of rare hypersensitivity reactions in patients taking Januvia, including anaphylaxis, angioedema, and Stevens-Johnson syndrome. The FDA indicated, however, that it was not overly concerned by the reports.
Source: Reuters; FDA, October 2007Click Here To View Or Post Comments