Jump to full article: MedPage Today, 2008-04-10
Author: Michael Smith, North American Correspondent, MedPage Today
Intro: The FDA has warned that more cases of lung cancers have been reported in patients treated with the inhaled insulin Exubera than in controls in clinical trials.
The warning is another blow to the star-crossed Exubera, which was hailed as the only new method of delivering insulin in 80 years when it was approved in 2006 (See: FDA Okays Inhaled Insulin for Type 1 and 2 Diabetes).
However, less than two years later, Pfizer, the drug's maker, said it was phasing the drug out because patients and doctors had been slow to accept it (See: Citing Lack of Acceptance, Pfizer Pulls Plug on Inhaled Insulin).
Some patients continue to use Exubera, especially those on Pfizer's extended transition program, initiated when the company pulled the plug on the medication.
In the clinical trials, the FDA said, there have been six newly diagnosed cases of primary lung cancers among Exubera patients and only one among controls treated with comparator medications.
. . .
The FDA said there have been "too few cases to determine whether the emergence of these events is related to Exubera" and the agency pointed out that all patients diagnosed with lung cancer had a history of cigarette smoking.
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