The statin revolution began in 1987, when lovastatin was approved by the Food and Drug Administration. Since then, this class of drugs has transformed cardiac medicine, says Allen Taylor, chief of cardiology at MedStar Georgetown University Hospital. “Cardiovascular disease affects one in two people. This is the one drug that works.”
But these drugs are not without risks. Golomb has amassed thousands of reports at her Web site Statineffects.com, detailing adverse reactions from statins. She says that cognitive problems are the second-most-common side effect reported in her database, after muscle pain. In a 2009 report in the journal Pharmacotherapy, Golomb described 171 patients who’d reported cognitive problems after taking statins.
The idea that a cholesterol-lowering drug could make your brain fuzzy might sound crazy, and Golomb says the notion was greeted with suspicion at first. But eventually the FDA received enough such reports that last February it ordered drug companies to add a new warning label about possible memory problems.
No one knows how common the cognitive side effects are. Golomb says the data that she’s collected are all self-reported and voluntary. And the FDA’s MedWatch database is similarly built of mostly voluntary reports, though drugmakers are required to submit to the FDA adverse events that they know about. So without more systematic tracking, it’s impossible to measure how commonly these side effects occur. Many doctors believe the problem is fairly rare, posing little risk for the tens of millions of people using statins every day to keep their cholesterol levels in check.
“It’s not a very common side effect,” says Orli Etingin, an internist and professor in women’s health at Weill Cornell Medical College in New York. “But it’s definitely real. Typically, it’s a fairly high-functioning woman who is having difficulty remembering and multi-tasking.”
Taylor points out that clinical trials on statin use have never turned up memory problems and that researchers once held hopes that the drugs might actually prevent cognitive decline. However, a 2002 clinical trial designed to determine whether statins might decrease the risk of memory problems in elderly patients found no difference in cognitive function between participants who took pravastatin and those who didn’t.
“I’m very skeptical [of the link between statins and memory problems],” Taylor says. Most patients taking statins have a greater risk of developing cognitive decline from heart disease [which can impair blood flow to the brain] than from the drugs.