Consumers Union Opposes Over-the-Counter Choles...( FDA panel considers application T...),Health

FDA panel considers application Thursday; CU asks for safety review of statins

WASHINGTON, Dec. 11 /PRNewswire-USNewswire/ -- Consumers Union is urging the FDA to reject Merck's latest application to sell an over-the-counter version of the cholesterol-lowering medicine Mevacor, primarily because high cholesterol can't be self-diagnosed, many people with elevated cholesterol can bring it under control with diet and lifestyle changes, and statins are potent drugs that can have serious side effects.

Two FDA advisory panels meet in joint session Thursday to consider Merck's application. The pharmaceutical company was overwhelmingly turned down in January 2005 by a previous FDA committee for virtually the same OTC application.

Consumers Union sent a letter on Nov. 16, 2007, to FDA Commissioner Andrew von Eschenbach requesting that the agency initiate a formal review within 18 months of the adverse events caused by, and long-term safety of, statin drugs in various populations. CU is publicly releasing that letter today at http://www.ConsumersUnion.org.

"Statins are among the most widely prescribed and studied drugs in the U.S, and by all accounts they are highly beneficial," said Steven Findlay, managing editor of the Consumer Reports Best Buy Drugs project. "But there are still things we need to better understand about their benefits and risks."

"In the context of Merck's application, it is timely for the FDA to take a close look at the research on these medicines, with special attention to changes in the patterns of their use in recent years," Findlay added.

Among the issues:

-- The safety of statins over the long-term at the higher doses used more commonly today, especially among people who do not have diagnosed heart disease or multiple risk factors for heart disease.

-- The benefits versus risks of statins over the long-term in people
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