Pfizer has report that clinical trials of the inhaled insulin Exubera found increased cases of lung cancer.
The lung-cancer news is a setback to Exubera, which held the promise of letting diabetics avoid needle sticks.
Pfizer has reported that six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.
Pfizer will update the product's labeling to include a warning with safety information about lung cancer cases found in patients who used Exubera, which U.S. regulators approved in January 2006.
The warning states all patients who developed lung cancer had a history of cigarette smoking, and that too few cases existed to determine whether the development of lung cancer is related to Exubera use.
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