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Inhaled Insulin Afrezza: FAQ

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With Afrezza, "there is also less weight gain," Bode says. He credits that to the shorter time Afrezza remains in the body.

In another study, researchers found that people with type 2 diabetes who weren't getting enough control of blood sugar with oral medications did better when they added inhaled insulin before meals.

Both studies were presented at the American Diabetes Association meeting in June.

The FDA approved Afrezza's safety and effectiveness based on about 3,000 people, including 1,000 with type 1 diabetes and about 2,000 with type 2.

What about side effects?

In the Afrezza clinical trials, the most commonly reported side effects were low blood sugar, cough, and throat pain or irritation, according to the FDA.

The drug will carry a warning that it could cause sudden tightening of the chest, known as acute bronchospasm.

It is not recommended for people with asthma or COPD, or in smokers. It isn't recommended to treat diabetic ketoacidosis, a serious complication when the body makes high levels of blood acids known as ketones.

The FDA is also requiring further study to evaluate the potential risk of lung cancer.

Is this a game-changer for people with diabetes?

Some experts think so, but others are taking a wait-and-see approach.

"I think it is," Campbell says. He says the inhaler for Afrezza is better designed and easier to use than a more cumbersome one used with another inhaled insulin, Exubera, he says.

Exubera was approved by the FDA in 2006 but withdrawn from the market by its maker, Pfizer, in 2007, in part due to low sales.

Health care providers had to spend a half hour or so just to explain how to use the Exubera inhaler, Campbell says. The Afrezza inhaler, he says, ''is really small, easy to use, and it takes less than a minute to train a patient how to use the insulin."

Marie McDonnell, MD, director of the Brigham Diabetes Program at Brigham and Women's Hospital, says Afrezza has promise if "we can show there is no risk to the lung tissue and the mouth and esophagus."

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