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[personal profile] walkitout
This is from back in March:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205215.htm

And this is from today:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258338.htm

There's some secondary coverage of associated guidelines:

http://www.webmd.com/cholesterol-management/news/20110608/fda-zocor-simvastatin-dose-limit

Basically, a particular statin can be prescribed at a variety of dosage levels. The FDA is saying you can no longer _start_ anyone at the highest dose. If someone has been on that dose for 12 months, they can keep taking it. Think of this as ratcheting back. What to do if someone meets criteria for upping the dose to that point (that is, cholesterol persistently higher at the next notch down)? Prescribe something else instead, says the FDA.

Statins have been a Can Do No Harm blockbuster category for at least a decade now. We've been in an era in which more people are prescribed higher amounts of these drugs (right down to let's-just-put-it-in-the-water jokes). For the entire time frame, there have been persistent reports of really severe muscle damage associated with the drugs. This is the _FIRST_ (AFAIK) limit put on prescribing these drugs.

About fucking time.

If history rhymes, expect further ratcheting back, as more and more attention is paid to Rhabdomyolysis and we start realizing it wasn't really all that rare as we thought it was.

ETA:

http://www.ehow.com/facts_5021450_myopathy-rhabdomyolysis.html

To be clear, the FDA is not drawing attention to rhabdomyolysis, possibly because it's incredibly embarrassing to realize that attempts to reduce cholesterol in otherwise asymptomatic people is resulting in people taking advantage of the dialysis benefit. For one thing, people might not take your advice as seriously next time. Instead, the FDA is pointing to the much more common and much less serious (initially) myopathy.

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