The FDA is set to consider approval of Pfizer’s inhaled insulin drug Exubera. A year or two ago it would have been an easy decision –the drug is a convenient alternative to injected insulin. But in the post-Vioxx era it’s being looked at differently. After all, the drug doesn’t work better than injected insulin, and has some safety concerns. The safety issues appear minor –a slight drop in breathing capacity that apparently stabilizes over time– but who knows what will happen in a much larger population once the drug is approved?
So the question becomes: in the post-Vioxx era, how will the FDA weigh the added convenience of inhaled insulin –which is a big deal to some people– with the probably small but less certain risk? Personally, I’d vote for the drug’s approval and put the responsibility in the hands of physicians and pharmacists to help patients evaluate what is best for them.September 8, 2005