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In April 2008, Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through through your mouth using the Exubera inhaler, that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancy (lung cancer) in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among patients in clinical trials receiving other treatments for diabetes. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases, however, to determine whether the emergence of these lung cancer events is related to the use Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.

Other important safety information about Exubera includes:

• Exubera is a rapid-acting insulin indicated for the treatment of adults with diabetes mellitus for the control of hyperglycemia (high blood sugar). In patiens with type 1 diabetes, Exubera should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, Exubera can be used as monotherapy or in combination with oral agents or longer-acting insulins.

• Exubera is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting Exubera therapy. If a patient starts or resumes smoking, Exubera must be discontinued immediately due to the increased risk of hypoglycemia (low blood sugar) and an alternative treatment must be used.

• Exubera is contraindicated in patients with unstable or poorly controlled lung disease because of wide variations in lung function that could affect the absorption of Exubera and increase the risk of hypoglycemia or hyperglycemia. The use of Exubera in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of Exubera in this patient population has not been established.

• Hypoglycemia is the most commonly reported adverse event of insulin therapy, including Exubera.

• In clinical trials, treatment with Exubera was associated with small, non-progressive declines in pulmonary function relative to comparator treatments. Because of the effect of Exubera on pulmonary function, all patients should have pulmonary function tests (e.g., spirometry) assessed prior to initiative therapy with Exubera, after 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms.

• The long-term safety and efficacy of Exubera in pediatric patients have not been established.

• In clinical studies, respiratory adverse events included cough, which tended to occur within seconds to minutes after Exubera inhalation. The incidence of cough decreased with continued Exubera use. Other respiratory adverse events included:

  • dyspnea - shortness of breath
  • pharyngitis - inflammation of the pharynx (sore throat)
  • increase in sputum production
  • epistaxis - nosebleed

• Non-respiratory adverse events reported in Exubera-treated patients include hypoglycemia, chest pain, and dry mouth.

Side Effects of Insulin Therapy