Safety of Inhaled Insulin Questioned by FDA

Federal regulators have issued a report that raises questions about the safety of an experimental inhaled insulin device that is seeking Food and Drug Administration approval.

The report is included in a briefing designed for the Food and Drug Administration advisory committee which will begin to discuss approval for the device at the start of next month.

The device in question, Afrezza, is a whistle-sized inhaler developed by MannKind Corp. that delivers "rapid-acting" insulin that reportedly takes a much faster effect on a diabetic's body than the leading insulin injectors.

It is the hope of MannKind that the device will become immediately popular for use among both type one and type two sufferers of diabetes because of the convenience and increased comfort of the product compared to some bulky insulin injection systems currently on the market.

However, the device has to get past a skeptical FDA first. Back in 2011, the FDA denied Afrezza approval, asking for two more clinical trials -- one trail for each type of diabetes -- to prove that a second-generation version of the device that had been in works was equivalent in effectiveness and safety as the initial product the FDA had first received reports on.

Following these latest trails and an analysis of all available data on the Afrezza devices, called the Dreamboat and the MedTone, new questions about the safety of the insulin delivery approach have been raised.

The FDA review found that four cases of lung cancer occurred in patients who used the devices during trials. However, two of these patients were found to have had a prior history of heavy tobacco product use. The two remaining cancer patients has no history of smoking, but experts from the FDA reasoned that compared to the sample size of the combined trials, the likelihood of a natural development of lung cancer without the influence of Afrezza matched the numbers that were seen.

Still, FDA experts write that the possibility that the devices increase the risk of lung cancer in users should still be considered and warrants discussion.

A briefing for the FDA advisory committee was published on Friday and the committee will meet to discuss approval of the device on April 1.

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