FRIDAY, Jan. 27, 2006 (HealthDay News) -- Pfizer's Exubera, an inhaled form of insulin, was approved by the U.S. Food and Drug Administration on Friday. It represents the first new insulin delivery option for America's more than 5 million diabetics since discovery of insulin in the 1920s, the agency said. Up to now, insulin has been administered by injection.
Exubera's safety and effectiveness were studied in more than 2,500 adults with type 1 and type 2 diabetes. Peak insulin levels were achieved in an average of 49 minutes, versus an average of 105 minutes with some regular insulins that were injected, the FDA said.
Pharmacists will be required to accompany Exubera prescriptions with an FDA-approved information guide, the agency said. "Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly," the FDA said in a statement.
Exhubera should not be used by current smokers or by those who quit within the last six months, the agency said. It's also not recommended for people with asthma, bronchitis, or emphysema.
Pfizer will conduct long-term studies of the drug's effectiveness and safety, especially among patients with underlying lung disease, the FDA said.
To learn more about diabetes, visit the American Diabetes Association.