The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA), together with 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.
ACTIONS THAT HEALTHCARE PROFESSIONALS SHOULD FOLLOW:
REPORT ADVERSE DRUG REACTIONS TO THE SFDA
The public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the internet at: