Inhaled Insulin Safety Setback

By | 2022-02-07T17:58:34-05:00 May 26th, 2008|0 Comments

In the wake of an increased incidence of lung cancer reported among patients using the inhaled insulin Exubera, the manufacturer and the Food and Drug Administration has required new precautions and labeling changes. Exubera is a short-acting insulin administered at mealtime through a hand-held oral inhaler.

While Exubera is the only inhaled insulin product currently approved for use in the U.S., the manufacturer ceased marketing the product late last year due to unsatisfactory sales revenue. Some patients, however, remain on Exubera therapy, using “stockpiled” medication or by obtaining medication from pharmacies that still have stock on hand.

The safety concerns and recent labeling changes were prompted by clinical trial data that revealed six newly diagnosed cases of primary lung malignancies among Exubera-treated patients compared to one among patients not treated with Exubera. Final data analysis has not been performed that clearly links drug use to cancer risk. The issue is further complicated by the fact that all patients who were diagnosed with lung cancer had a prior history of cigarette smoking.

Patient teaching: Remind patients who remain on Exubera that smoking is an absolute contraindication to Exubera use. Patients exhausting their supply of Exubera will need alternative treatment for hyperglycemia. For many, this will require initiating insulin injection therapy for the first time.

Review current drug information before administering and monitoring medications.


Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.

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