New Warning for Statins

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Statins, including Pfizer Inc.’s Lipitor, are among the most prescribed drug in the world, and are currently routinely taken by millions of Americans. They are indicated for people with high blood pressure and/or high cholesterol, and have been shown to significantly reduce the risk of heart disease, heart attack, and stroke in this population. Yet the FDA has just issued new warnings concerning potential side effects: elevated blood sugar, which is a risk factor for developing type 2 diabetes, and cognitive impairment such as memory loss. The warnings will not be affixed to the outside of the bottle, but will be included in the package insert that comes with all prescription medications.

Statins


The FDA constantly monitors the medical literature and clinical trial data to keep abreast of newly reported side effects of approved drugs. Recent studies of Crestor, a statin made by AstraZeneca, revealed that it was associated with an elevated risk of developing type 2 diabetes. Memory loss has not been associated with statin use in any formal study, but comes from many anecdotal reports. People taking statins have been complaining of “fuzzy” thinking and their inability to recall words; both of these disappeared once they went off of the drug. Doctors often disregarded this complaint in their patients as a normal part of aging, but the FDA wanted people to be aware of the potential correlation.

Doctors can also belittle complaints of muscle pain in older patients. But many of these patients are taking multiple prescription drugs, and statins have in fact been shown to increase the risk of muscle injury in combination with some other drugs. Lovastatin’s new warning label clarifies this risk as well, listing which drugs should be avoided if one is taking it and noting the maximal dose of Lovastatin if these combinations cannot be avoided.

Interestingly, a warning that has been affixed to statins to date is now being removed, this one for the periodic monitoring of liver enzymes. It was there because early clinical trials suggested that statin use could lead to liver damage. Cholesterol is formed in the liver, so that is where statins do their work. But this liver damage is quite rare, and monitoring liver enzymes could not predict who might develop it or in any way prevent it. Perhaps blood sugar, levels should now be monitored instead.

Statins still clearly have enormous benefits; they are very good at lowering cholesterol, and thereby lowering the risk of heart attack and stroke. They continue to be invaluable for those at high risk of cardiovascular disease, such as those with genetic high cholesterol. Amy G. Egan, M.D., M.P.H., the deputy director for safety in the FDA’s Division of Metabolism and Endocrinology Products, put it like this [1]:

Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.

New drugs that have fewer side effects and are potentially more effective than statins are on the way. A recent study published in The New England Journal of Medicine evaluated a new drug called REGN727, a monoclonal antibody that blocks the action of a protein that helps to limit the amount of low-density lipoprotein (LDL), or bad cholesterol, that liver cells can remove from the bloodstream [2]. By blocking the inhibiting protein, liver cells can remove much greater amounts of LDL from the body. Indeed, the results of unpublished studies show that REGN727 in patients already taking Lipitor can reduce LDL by an additional 40-70% compared with those on a placebo [3].

References

  1. FDA Expands Advice on Statin Risks. U.S. Food and Drug Administration Consumer Update. 2012 Feb 29.
  2. Stein et al. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012 Mar 22;366(12):1108-18.
    View abstract
  3. Drug to Cut Cholesterol Tests Better Than Statin. The New York Times. 2012 Mar 26.
About the Author

Diana Gitig, Ph.D., is a freelance science write based in White Plains, New York. She earned her Ph.D. in Cell Biology and Genetics from Cornell University's Graduate School of Medical Sciences.

Comments

  1. “The FDA constantly monitors the medical literature and clinical trial data to keep abreast of newly reported side effects of approved drugs” what they do not “constantly monitor–if they monitor it at all, are consumer reports of adverse effects. i personally wrote the FDA letters and compliantly filled out the “adverse reporting” form reporting my husband’s cognitive dysfunction and onset of neurodegenerative disease in 2004. I never received acknowledgement or answers to my pleas to have statins investigated in reference to onset of cognitive problems and neurodegenerative diseases. I do not feel in any way assured the FDA is looking out for my husband’s nor my welfare; only the Pharmaceutical industry benefits from that. Is it not more than interesting that these new warnings did not surface until Lipitor’s patent had expired? I will continue to work for righting the wrong caused by the Pharmaceutical Industry and the FDA.

  2. There is a simple solution to the problems of side effects from drugs like lipitor. I think looking at how you can solve the problem naturally should always be the first choice of action in most circumstances. Exercise and diet could solve most of the western world’s health problems including ‘bad’ cholesterol and heart disease.