Afrezza: FDA Clears Use for Children 6 and Older With Type 1 or Type 2 Diabetes

Afrezza is a fast-acting insulin that you breathe in as you start a meal. It lowers blood sugar by helping your muscles and fat use sugar and by telling your liver to make less sugar. It is approved to improve blood sugar control in adults and in children 6 and older with diabetes. You must use it only with the Afrezza inhaler. This is not an injection. You take it right when you begin eating. This approval now includes younger people. The FDA cleared Afrezza for children and teens 6 to 18 years old who have type 1 diabetes (T1D) or type 2 diabetes (T2D). That makes Afrezza another mealtime choice for some families who want an option that is inhaled instead of injected.

Why Was It Approved?

In studies of adults with T1D, Afrezza was used at meals together with a long-acting basal insulin. It met the study goal for being close enough to injected rapid-acting insulin for A1c change, but the injected option lowered A1c more. In adults with T2D already taking oral diabetes medicines, Afrezza reduced A1c more than placebo. These results supported that Afrezza can help manage after‑meal blood sugar. Afrezza was also studied in children and teens 6 to 17. When added to basal insulin, Afrezza did not match injected mealtime insulin for A1c change at 26 weeks, which was the main goal of that study. Lung function changes on breathing tests were similar between groups over that time. Overall, safety in kids looked like what was seen in adults. Side effects to know about include low blood sugar, cough, and throat pain or irritation. Serious low blood sugar can happen. In studies of T1D, diabetic ketoacidosis (a dangerous buildup of acids in the blood) happened more often with Afrezza than with the other treatments studied. If you have T1D, you should always use Afrezza together with a basal insulin.

What Do I Need to Know?

You inhale Afrezza at the start of each meal using only the Afrezza inhaler. Your health care provider will train you on how to use it. After training, some older children may be able to use it on their own if the health care provider agrees. Replace the inhaler about every 15 days.

Do not use Afrezza if you have long‑term lung disease, such as asthma or chronic obstructive pulmonary disease (COPD). Before starting, your health care provider will check your health and test your lungs with a breathing test. Afrezza is not recommended if you smoke or have recently stopped smoking.

Your health care provider will test your lungs again about six months after starting and then every year, even if you feel fine. Watch for low blood sugar. Know the signs, have a plan to treat it, and check your levels more often if you are at higher risk or do not feel warning signs as clearly.

Do not use Afrezza to treat diabetic ketoacidosis. If you have T1D, always use Afrezza with a basal (long‑acting) insulin. Get help right away if you have trouble breathing after a dose or signs of a severe allergic reaction, such as swelling, rash, or fainting.

Many medicines can raise or lower how well Afrezza controls your blood sugar or can hide signs of low blood sugar. Share a full list of your medicines with your health care provider and pharmacist, including any inhalers. Ask how to time doses and monitor your sugars when starting, stopping, or changing other medicines.