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Inhaled insulin increases lung cancer risk
Apr 10, 08 Clinical Updates FDA warningsClinical trials of the inhaled insulin Exubera found increased cases of lung cancer, Pfizer Inc and Nektar Therapeutics said on Wednesday.
Over the course of the clinical trials, Pfizer said 6 of the 4,740 Exubera-treated patients versus 1 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 updated the Exubera 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 there were too few cases to determine whether the development of lung cancer is related to Exubera use.
Pfizer said it will stop marketing Exubera in October. Sales of the drug have been negligible.
The warning in the label stemmed from an ongoing review of data from the Exubera clinical trial program and post-marketing experience by Pfizer and the U.S. Food and Drug Administration, Pfizer said.
NEW YORK (Reuters)
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