FDA Approves First Inhaled Insulin

FDA recently approved Exubera, the first inhaled insulin product. It's a powdered form of recombinant human insulin that is self-administered using a specially designed inhaler. Exubera, manufactured by Pfizer, is intended to treat types 1 and 2 diabetes in patients over the age of 18. For patients with type 1 diabetes, Exubera can replace the short-acting insulin that is generally taken with meals, because with the inhaled form of insulin, patients can achieve peak levels of insulin quicker than with the injectable form. But Exubera doesn't replace their longer-acting insulin -- Type 1 diabetics will still have to take injections for that. With type 2 diabetics, Exubera can be used alone, or in combination with oral antidiabetic drugs or longer-acting injectable insulin. Because Exubera is a fine powder that could have an affect on the lungs, the drug isn't recommended in patients with underlying lung diseases such as poorly controlled asthma, COPD or emphysema. And it should not be used by smokers. It's also recommended that patients receive a baseline pulmonary function test prior to starting Exubera, with repeat tests after six months on the drug and then every year thereafter, even if there are no pulmonary symptoms. Pfizer will do long-term studies of the drug to continue to look at safety issues, such as the effect of Exubera on patients with underlying lung disease. Every time patients fill a prescription for Exubera, they'll be given a Medication Guide. The Guide explains how the drug is to be used, contraindications, and possible side effects. It also lets patients know about possible effects on the lungs, and about the need for periodic lung function tests.