If this does get pulled, it won't be because of the deaths, or at least not primarily -- the media will make it about the deaths, the politicians will make it about the deaths, but the people actually looking at this in-depth to make decisions will not. It would be because if this drug was presented to the FDA as a new drug today, it wouldn't be approved. To be approved today, a prescription-strength pain med would need to be able to show that it either does a better job at relieving pain than OTC pain meds (or in comparison to other prescription pain meds), and/or that it has a lower rate of significant side effects. With what we know from current research, neither is the case with this particular class of meds.
When it was approved, the minimal efficacy of the drug seemed "good enough" in comparison to a) the other meds out there, and b) what we knew about the side effects. Since then, more pain meds have entered the market that show better results with fewer side effects, and we've learned more about this class of meds in terms of both effectiveness and and side effects.
I do think there have been several recent cases where drugs have been inappropriately pulled -- often due to politics and public pressure -- but I just don't see this as being one of them. The data here justifying this reaction is *far* more solid than the data for the SSRI warnings, for the rotavirus vaccine pull, or for the nacrolepsy drug pull.
As a researcher, is this a removal I'd be lobbying the FDA for? Not likely -- I think the shortcomings of these drugs are pretty widely known, and that most docs are prescribing them knowing what they're getting into. There are far bigger fish for me to fry. But there are drug pulls I have and will lobby against, and this wouldn't be one of them, not by a long shot.
| Year | Number of comments posted |
|---|---|
| 2006 | 2 |
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