FDA Should Deny Over-The-Counter Access to Risky Cholesterol Drug

Dec. 13, 2007

FDA Should Deny Over-The-Counter Access to Risky Cholesterol Drug

Public Citizen Testifies About Dangers of Mevacor

WASHINGTON, D.C. –   Making the cholesterol medicine Mevacor available over the counter could lead to widespread and possibly dangerous, inappropriate use of the drug, a fear backed up by the maker’s own data, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, told federal regulators Thursday.

A Food and Drug Administration (FDA) analysis of a recent Merck study shows that up to 93 percent of the people deciding on their own to purchase Mevacor should not take the drug, Wolfe said at a joint FDA and Center for Drug Evaluation and Research hearing.

Merck, which has seen its share of the cholesterol-drug market plummet because of competition from generic brands, has applied to make Mevacor available over the counter (OTC). Like other drugs in the “statins” classification, Mevacor (generically known as lovastatin) is used to help lower cholesterol, which may prevent a first heart attack if used by the right group of people.

“Merck is again engaged in its desperate effort to gain OTC approval for a drug that could well cause more harm than benefit were it to be approved,” Wolfe told the joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee.

Despite Merck’s assertion that consumers can properly assess the warnings, the FDA analysis of Merck’s data shows that many people who shouldn’t be taking Mevacor – such as women of childbearing age, some people who have already had heart attacks and strokes and people whose heart risk is too low to warrant the use of a statin – would buy Mevacor if it were available without a prescription.

This could cause serious problems for women who become pregnant while on the drug. A National Institutes of Health report shows that cholesterol drugs like Mevacor can cause birth defects. If approved, it would be the only over-the-counter drug allowed that falls under the FDA’s “Category X,” which is for drugs where the risks to pregnant women and fetuses outweigh the benefits.

For consumers who have already had heart attacks or strokes, the Merck study results indicate some would switch from their prescription medicine to Mevacor, which in many cases would be a weaker drug than they need.

Additionally, the analysis of the Merck data shows that 21.5 percent of people deciding on their own to purchase Mevacor over the counter did not need the drug.

“This large proportion of purchasers would therefore be exposed to the risks of Mevacor – such as liver damage, muscle damage and other adverse effects – without evidence of any benefit,” Wolfe testified.

“As in earlier testimonies at the 2000 and 2005 FDA advisory committee meetings, we strongly oppose the switch of lovastatin or any other statin to OTC status,” Wolfe said. “With each look at the latest evidence, the case against a switch becomes clearer.”

READ Wolfe’s testimony.

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