Exubera Gets Lung Cancer Warning

Yael Waknine

April 09, 2008

April 9, 2008 — Updated labeling for insulin human (rDNA origin) inhalation powder now warns smokers regarding a potential risk for lung cancer, the US Food and Drug Administration (FDA) warned today. The product is marketed as Exubera by Pfizer under license from Nektar Therapeutics. The product is marketed as Exubera under license from Nektar Therapeutics.

Data from the company's clinical trial program have revealed that 6 of 4740 patients taking inhaled insulin developed lung cancer compared with 1 of 4292 patients who received an active comparator (incidence, per 100 patient years exposure, 0.13 vs 0.02). Postmarketing reports also identified 1 case of lung cancer.

All patients who were diagnosed with lung cancer had a prior history of cigarette smoking, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program. However, the data were insufficient to establish a causal role for the product.

Pfizer previously announced that it would cease marketing the product because it did not meet either consumer needs or the company's financial expectation. Today's announcement coincides with that of Nektar Therapeutics stating that it has terminated all negotiations with potential partners for inhaled insulin.

"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Joe Feczko, MD, Pfizer's chief medical officer.

Insulin inhalation powder is indicated to improve glycemic control in adult patients with diabetes mellitus.

Adverse events associated with use of inhaled insulin should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.