Dark Side of Statins Part 3 FDA Steps In

I'd like to think that the Food & Drug Administration (FDA) values my opinion enough to read this blog but that's a pipedream.  However, last month I did point out a series of studies demonstrating an association between statins and diabetes.  Granted all the studies were observational in nature, thus perfect for developing hypotheses, rather than randomized controlled trials useful for declaring cause & effect.  Still, earlier today, the FDA apparently found the evidence compelling enough to make label changes to warn of the possibility of hyperglycemia.  

One bit of good news:  we don't have to worry about regularly and routinely monitoring liver functions anymore (except as a prior to initiation).  And from the glass is half full/empty department, the FDA is finally admitting to the possibility of cognitive effects (memory impairment, etc) associated with statin use which had been widely reported in the blogosphere but officially denied until now.  So, no, you weren't imagining it but the reality is we don't know what to do.  On the other hand, this does open the doorway to more studies to determine who's at greater risk and why.  And hopefully to determine how to mitigate said risk.  Of course, this is truly ironic since statin use has also been associated with lower risk of dementia.  Hopefully, we'll get to the bottom of this sooner rather than later.

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