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U.S. Department of Health and Human Services

Safety

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Exubera (insulin human rDNA origin) Inhalation Powder

Audience: Endocrinologists, pulmonologists, pharmacists, patients

[Posted 04/09/2008] 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 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 malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.

[April 9, 2008 - Dear Healthcare Professional Letter - Pfizer, Inc.]
[April 9, 2008 - Dear Patient Letter - Pfizer, Inc.]