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FDA MedWatch-Exubera (insulin human rDNA origin) Inhalation Powder-Prescribing Information Updated To Include Information About Primary Lung Malignancies In Patients In Clinical Trials

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ROCKVILLE, Md., April 10, 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 the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.

Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and Dear Patient Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#exubera

Posted: April 2008


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