April 09, 2008 -Pfizer Inc said today that it updated the United States product labeling for EXUBERA® (insulin human [rDNA original]) Inhalation Powder to include a warning with safety information about lung cancer cases observed in patients who used Exubera. This update is based on an ongoing review of the data from the Exubera clinical trial program and post-marketing experience by Pfizer and the Food and Drug Administration (FDA). Since the inception of the program, Pfizer has continuously monitored respiratory safety. Over the course of the clinical trial program, 6 of the 4,740 Exubera-treated patients versus 1 of the 4,292 patients not treated with Exubera developed lung cancer. In addition there was a post-marketing report of lung cancer in one Exubera-treated patient. The update to the labeling states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera... Pfizer's Press Release -
