MONDAY, June 30, 2014 (HealthDay News) -- An inhaled medication, Afrezza (human insulin), has been approved by the U.S. Food and Drug Administration to treat adults with diabetes. The rapid-acting, inhaled insulin is designed to be used within 20 minutes of beginning a meal, the agency said.
Diabetes affects an estimated 25.8 million people in the United States, including 7 million who haven't been diagnosed, the FDA said in a news release. Serious complications could include heart disease, blindness and damage to the nerves and kidneys.
Afrezza's safety and effectiveness were evaluated in clinical studies involving more than 3,000 people, of whom about two-thirds had type 2 diabetes and the rest had type 1 diabetes.
The drug is not meant to replace long-acting insulin, and must be used in combination with long-acting insulin in people with type 1 disease, the FDA said. It should not be used to treat diabetic ketoacidosis or by smokers, the agency added.
Afrezza has a boxed label warning that users with chronic obstructive pulmonary disease (COPD) could develop a respiratory condition called acute bronchospasm. The drug, therefore, shouldn't be used by people with COPD or other forms of chronic lung disease such as asthma, the FDA said.
The most common side effects of the drug are hypoglycemia (low blood sugar), cough and throat pain or irritation.
The FDA said it ordered several post-approval studies to evaluate the drug's use among children and the potential risk of developing lung cancer.
Afrezza is manufactured by MannKind Corp., based in Danbury, Conn.
To learn more about this approval, visit the FDA.