Exubera: Inhaled insulin approved by FDA

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Exubera: Inhaled insulin approved by FDA

Exubera, inhaled insulin powder, gets FDA approval. Find out what it means for you.

What happened? The Food and Drug Administration (FDA) has approved Exubera, the first inhaled insulin, for treatment of adults with type 1 or type 2 diabetes. Exubera is a fast-acting, dry powder form of human insulin that's inhaled into your lungs to regulate (lower) your blood sugar level. It's administered using a hand-held inhaler and offers a new, painless alternative to traditional insulin injections.

Clinical studies have shown that Exubera reaches a peak insulin concentration in the blood more quickly than does injected regular insulin. In type 1 diabetes, inhaled insulin may be used along with injected longer acting insulin to replace short-acting insulin taken with meals. In type 2 diabetes, inhaled insulin may be used alone, with oral (noninsulin) pills that control blood sugar or with longer acting insulin.

What does this mean to you? If used as directed, Exubera may be an effective, more convenient medication for managing your blood sugar level. It should be used as part of your comprehensive diabetes management plan.

Low blood sugar (hypoglycemia) is a potential side effect of insulin, including Exubera. If you're using Exubera, carefully monitor your blood sugar level. Other side effects associated with Exubera therapy include cough, shortness of breath, sore throat and dry mouth.

Don't use inhaled insulin if you smoke or if you quit smoking less than six months ago. Exubera is not recommended for people with pulmonary diseases, such as asthma, bronchitis or emphysema.

Studies are planned to assess the long-term safety of Exubera and to further examine risks and effectiveness of the drug in people with lung disease. Exubera is currently not recommended for children younger than age 18 or women who are pregnant. Talk to your doctor to determine if Exubera is a good option for you.

Last Updated: 07/24/2006
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