Label Changes for:

Exubera (insulin human [rDNA origin]) Inhalation Powder

September 2008

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

MEDICATION GUIDE

  • What are some of the possible side effects of Exubera?
    • In studies of Exubera in people with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All the people in these studies who developed lung cancer used to smoke cigarettes. There were too few cases to know if the lung cancer was related to Exubera.

WARNINGS

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 postmarketing 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 3800 patient-years) for Exubera-treated patients and 0.03 (1 case over 3900 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.

For current prescribing information contact Pfizer at 1-800-879-3477.

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