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NPR's Joanne Silberner has more.
JOANNE SILBERNER: FDA officials have announced the approval of the new product called Exubera with some exuberance. Steven Galson directs the Center for Drug Evaluation and Research.
STEVEN GALSON: this is a very highly innovative product that has the potential to improve the quality of life for millions of Americans with diabetes.
SILBERNER: But he was careful to say it's not for everyone.
GALSON: It will not replace all injectable insulin and should not specifically be used by smokers.
SILBERNER: Also, people with asthma or other breathing problems. And because studies have not yet been done in children, the FDA approved Exubera only for people 18 and older. Exubera is fast acting, and some people including all those with Type I diabetes will still have to take a slow-acting injectable insulin. So not all five million people who depend on insulin injections can forego their shots.
FDA: occasional low blood sugar, coughing, shortness of breath and dry mouth. But overall, it appears to be safe. The FDA's Robert Meyer.
ROBERT MEYER: Some patients were studied out as long as seven years. We have a large amount of data from the clinical trials speaking to the safety of this product overall, and the safety of this product in the lungs, as well.
SILBERNER: Exubera is a powdered form of insulin that comes with a new type of inhaler the size of an eyeglass case.
MEYER: It's sort of a device that opens up to have a clear tube at the top. And the bottom, you put in a insulin packet that contains the powder. You cock the device much the way you would almost a BB rifle. That forced air forces the insulin into an aerosol in this chamber that the patient then inhales from.
SILBERNER: Nathaniel Clark takes care of patients with diabetes and is an official with the American Diabetes Association. He said the product has some advantages and some disadvantages.
NATHANIEL CLARK: The advantage, obviously, of inhaled insulin is that it's inhaled and not injected. And the disadvantage of inhaled insulin is many patients may find it more cumbersome in comparison to the currently available injectable insulin; such as insulin pins, which have become extremely convenient and essentially painless to the size of the needle, et cetera.
SILBERNER: Joanne Silberner, NPR News, Washington.
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