The Exubera label has been updated by Pfizer and FDA ( Food and Drug Administration ).
The update resulted from Pfizer and FDA ’s safety reporting and review processes related to clinical trials program and post-marketing reports.
A new Warning was added to the Exubera prescribing information as follows:
In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies 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.
In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 ( 5 cases over 3900 patient-years ) for Exubera-treated patients and 0.02 ( 1 case over 4100 patient-years ) for comparator-treated patients.
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.
Exubera remains a safe and effective medication.
Source: FDA, 2008
Link: Xapedia - Medical Encyclopedia