Pfizer has informed that it has updated the US product labeling for Exubera ( Insulin human ) Inhalation Powder to include a warning with safety information about lung carcinoma 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 ( FDA ( Food and Drug Administration ).
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.
Exubera has shown in clinical trials to be a safe and effective medicine in the treatment of adults with type 1 or type 2 diabetes.
Diabetes currently affects an estimated 230 million people worldwide and nearly 21 million in the United States. Despite the existence of available therapies for diabetes, millions of patients do not achieve or maintain acceptable blood sugar levels which can leave them at increased risk for the complications of diabetes.
Exubera is a prescription medicine that you breathe in through your mouth using the Exubera Inhaler. It is a short-acting Insulin that helps to control high blood sugar in adults with diabetes. In type 1 diabetes patients, Exubera should be taken with longer-acting Insulin; in type 2 diabetes patients, Exubera may be used by itself or with diabetes pills. Some patients with type 2 diabetes mellitus will need to take some longer-acting Insulin in addition to Exubera. ( Xagena )
Source: Pfizer, 2008