The insulin, called Afrezza, is a rapid-acting insulin and is meant to be taken at mealtime or soon after.
“Today’s approval broadens the options available" for delivering insulin in people with diabetes, Jean-Marc Guettier, MD, director of the FDA's Division of Metabolism and Endocrinology Products, says in a news release.
The FDA estimates that 18.1 million people have diabetes. About 7 million more are undiagnosed, the agency says.
This is the third time the drug was up for FDA approval. Its maker, MannKind Corporation, conducted additional safety studies after the first two attempts.
Patients with type 1 diabetes will need to use the drug in combination with long-acting insulin. Patients with type 2 diabetes will use it in combination with oral medications.
Afrezza carries a warning as it may cause a sudden tightening of the chest. It is not recommended for people with asthma or COPD. It is also not recommended for people that smoke or for the treatment of diabetic ketoacidosis.
"Our expectation is it should be priced comparably to current fast-acting insulins delivered in pen form," says Matthew Pfeffer, a spokesman for MannKind.
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If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.
People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.
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However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.
Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.
Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.
One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.
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