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Adverse Effects of Statins Much More Common Than Appreciated, Author Says

MedWatch data suggest risk of cognitive disturbance

Family physician Duane Graveline, MD, a former astronaut, used to prescribe statin drugs enthusiastically to lower cholesterol. Then he took them as a patient. When he published his experience with transient global amnesia in Peoples Pharmacy, he received approximately 30,000 emails describing the adverse effects of statins.

After the FDA’s MedWatch database became available, Graveline compiled adverse-event reports related to statins. His findings have been published in the spring 2015 issue of the Journal of American Physicians and Surgeons.

Physicians often dismiss reports of weakness or cognitive decline in statin patients, Graveline said. They may attribute these complaints to aging or say “statins don’t do that.”

Further, a recent FDA posting downplayed the risk of cognitive impairment as “generally not serious” and reversible within a few weeks of stopping statin therapy.

The FDA’s deputy director for safety, Amy Egan, MD, MPH, has advised patients not to stop taking statins if they experience “cloudy thinking.” Graveline notes, however, that an amnesic state so brief that the patient doesn’t notice it can be dangerous in an airline pilot or a heavy-equipment operator. He counted almost 9,000 MedWatch reports in the category of severe cognitive disturbance for atorvastatin (Lipitor, Pfizer) and rosuvastatin (Crestor, AstraZeneca) alone between 2006 and 2013.

Statins block an essential metabolic pathway, Graveline explains, leading to a deficiency in coenzyme Q10 (also known as ubiquinone) and dolichols. These factors are critical to the function of mitochondria, the body’s energy producers.

Accelerated aging appears to be a common feature of statins’ adverse effects, Graveline notes.

The most commonly reported adverse effects are muscle pain and weakness. The MedWatch database includes nearly 11,000 cases of rhabdomyolysis (the breakdown of muscle fibers), with approximately 1,000 deaths from kidney failure as breakdown products clogged the kidneys.

Both patients and physicians need to be better informed about the potential adverse effects of statin therapy, Graveline concludes. In his opinion, physicians must carefully assess the risks and benefits of treatment, and consider achieving the inflammation-reducing effects of statins with lower doses or alternate means.

Sources: PR Newswire; March 9, 2015; and Journal of American Physicians and Surgeons; Spring 2015.

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