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September 9, 2005
US Panel Recommends Exubera inhaled insulin
Good news for insulin users: an advisory panel voted 7-2 to urge the Food and Drug Administration to approve an inhaled insulin (Exubera).
Here's more from the Washington Post:
The FDA will consider the panel's advice. While the agency is not required to follow advisory panel recommendations, it usually does.About 12 percent of adult diabetics take insulin and oral medications, and 19 percent take insulin only, according to the American Diabetes Association.
Exubera's approval has been held up over concerns it might hamper lung function. In clinical studies, patients experienced a small decrease in lung capacity in the initial weeks of treatment. The changes did not worsen during two years of study and were reversible if Exubera was stopped, Pfizer said.
Exubera patients were more likely to report coughing but most cases were mild, Pfizer and FDA officials said.
While smokers or lung disease patients could be warned against taking Exubera, many diabetics might have undiagnosed lung problems, noted panel member Dr. James Stoller, a Cleveland Clinic pulmonologist. He voted against Exubera and called for more data about effects on lung disease.
Posted by Diabetologica at September 9, 2005 7:40 AM