Consumers Union Opposes Over-the-Counter Choles...(ing the risks of sideeffects. (4) Sta...),Health

(4) Statins are potent drugs that carry the risk of minor and serious side effects. It is unclear whether their benefits would outweigh their risks for some populations of people who might be induced to obtain an OTC statin.

(5) An OTC version of Mevacor is unlikely to yield significant savings to consumers over prescription generic lovastatin, which is generally available for under $30 and is a $4 drug at Wal-Mart and Target.

"There is simply too much potential for inappropriate, wasteful, or excessive use of OTC Mevacor without proper and useful medical supervision," Findlay said.

In its letter to the FDA, Consumers Union points out that one in 10 adults over age 20, and one in four over age 65, currently take a cholesterol-lowering statin - about 20 million people. That number could grow to between 25 and 30 million by 2010 as more prescriptions are being written for people whose primary diagnosis is not high cholesterol or heart disease but conditions (such as diabetes and kidney disease) that put them at risk for heart disease. In some cases, such patients don't even have high cholesterol.

The letter also cites a recent study suggesting that some doctors may have grown complacent about the adverse effects of statins. A study published in the August 2007 journal of Drug Safety found that 47 percent of doctors dismissed patients' complaints of muscle weakness and pain as being associated with their statin use, even though those symptoms are well-documented side effects of statins.

The Consumer Reports Best Buy Drug free, consumer-friendly report on statins' effectiveness, safety and affordability is available at http://www.CRBestBuyDrugs.org.