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FDA panel backs inhaled insulin

WASHINGTON -- Federal health advisers yesterday recommended government approval of the first inhaled form of insulin, offering some diabetics an alternative to many of their daily injections.

The recommendation by a Food and Drug Administration advisory panel came despite questions about use of the drug in people who have lung disease or were exposed to secondhand smoke.

No specific restrictions were recommended for Exubera, but FDA officials said smokers probably would not be able to use the drug. Their blood sugar could fall dangerously low with Exubera because they absorb much more inhaled insulin in their lungs than do nonsmokers.

Some advisers also were concerned that patients might not use the device properly. Drug company representatives suggested that the inhaler was not any more complicated than the injections many diabetics now must rely on.

Panel members twice voted 7-2 to recommend FDA approval of Exubera for each of the two most common types of diabetes. The drug is being produced by Pfizer, Sanofi-Aventis, and Nektar Therapeutics.

The FDA usually follows the recommendations of its advisory committees, but is not required to.

The advisers questioned the drug companies about the long-term effects of distributing insulin to the body through the lungs, rather than directly into the blood stream.

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