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New Statin Warnings Include Brain-Related Effects

The cholesterol-reducing drugs known as statins are popular, but the FDA wants Americans to know there are some side effects.
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Since 2009, Miller-McCune has taken a couple bites of the apple surrounding statins – a class of drugs used to lower cholesterol in the bloodstream – and whether there might be some unacknowledged health concerns for some users. Just about anything a human might ingest, from aspirin to water, might prove harmful in some cases, but we looked at statins because they were so popular (in 2009, we estimated 13 million in the U.S. alone were prescribed statins, and that figure is now believed to be north of 20 million) and yet there was little discussion of the drugs’ risks.

And there are side effects. Even what might be construed as boosting statin use, like the JUPITER clinical trials, noted side effects, but found the benefits of wider use likely exceeded the worries. But contrarians, as we termed them, remained concerned about overuse, (“Cholesterol Contrarians Question Cult of Statins”) and looked at things like memory loss, cognitive decline and neuromuscular disease (“Statins, Lou Gehrig and Big Questions”) as possible side effects that mitigated against a prescription free-for-all. (If you need convincing that these are commonly prescribed, look at the brand names involved: Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor, Zocor, Advicor, Simcor, and Vytorin …)

“I see that the bar for ‘high cholesterol’ keeps lowering,” our Tom Jacobs quoted biophysicist Yeon-Kyun Shin of Iowa State University. “There is a limit that the human brain can tolerate, which certainly depends on a lot of factors like age. Therefore, I certainly see the danger. More research needs to be done to determine how much cholesterol is high enough to take medication. I don’t think we have enough data to go lower and lower, which is a dangerous and baseless campaign.”

This week, the U.S. Food and Drug Administration changed the labeling for statins, specifically adding warnings about the possibility of memory loss and other brain-related effects, an increase in the risk of Type 2 diabetes and concerns about muscle injury in conjunction with one type of statin, lovastatin (sold as Mevacor). And on the positive side, the FDA reduced the requirement for periodic monitoring of liver enzymes in favor of a check before prescribing the drugs.

The FDA isn’t panicked over the drugs, to be sure. “The value of statins in preventing heart disease has been clearly established,” the agency’s Dr. Amy G. Egan was quoted. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

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