Saturday, November 10, 2012

FDA Votes For Degludec

The FDA recently approved the new insulin degludec, and the vote was 8 to 4. I thought the 4 who voted against made an excellent case for why it should not be approved, or at least not yet, and I strongly advise you to avoid using degludec, at least until larger studies show that what looks like an increase in heart attacks isn't. Because I think that at the least, there's evidence that there's not enough evidence to say it's safe.

The FDA votes against medications are usually on one of three grounds.
3. Possible human error would lead to problems. For instance, if U500 insulin was accidentally given instead of U100 insulin.
2. Not enough safety evidence, or trials were done poorly.
1. Medication's side effects are a really big deal compared to possible benefits.

In my opinion, a no vote because of #3 is something a consumer should be aware of but is not a reason to avoid a medication- after all, you know what user error you want to avoid. #2 is sometimes nitpicky, but if a medication doesn't hold big promise, then this is a reason to avoid it. #1 should really make you pay attention.
For degludec, members of the committee raised issues #1 and #2, because the studies were not well done and because the risk of heart attack was higher in the group using degludec vs glargine.

I started wondering what committe votes looked like for other insulins. Unfortunately, I didn't find them. So here's an FDA fact for you: in was founded in 1938, and prior to that, there was no review process required before the release of a drug in the United States or much of anywhere else.

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