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FDA Mulls Over-the-Counter Cholesterol Drug
Jan. 13, 2005 -- An FDA expert advisory panel is considering whether a popular cholesterol-lowering drug can be sold without a prescription.
The panel is scheduled to vote Friday on whether the statin drug Mevacor, sold generically as lovastatin, can be used safely without the aid of a doctor.
But FDA safety reviewers appeared to put the switch to over-the-counter status in doubt, warning that manufacturer Merck & Co. had largely failed to show that consumers could accurately determine on their own whether the medication was right for them.
Mevacor has been available with a doctor's prescription for 17 years and has been used by millions of patients. Merck officials told experts Thursday that making the drug available directly to consumers could help bring treatment to an estimated 11 to 18 million more patients at moderate risk for heart disease because of unaddressed high cholesterol.
The FDA first considered putting Mevacor over the counter in 2000. At that point the agency said there was simply no evidence to demonstrate the drug can be used safely and effectively without a prescription.
Mevacor lowers LDL "bad" cholesterol, and its effects have been shown to lessen the risk of heart attacks. Studies generally show that the drug cuts LDL by an average of 25% in patients who take it properly.
But whether patients unsupervised by their doctors will in fact take the drug as directed was a matter of intense debate at the advisory panel's first day of hearings.
FDA approval of a statin drug as an over-the-counter product would be unprecedented because it is intended to treat a chronic condition with no physical symptoms. Consumers use almost all other over-the-counter drugs to treat symptoms and can stop when the symptoms go away.
"You're taking it for a preventive strategy rather than just treating a headache or a runny nose," Alistaire Wood, MD, a professor of medicine at Vanderbilt University and chairman of the advisory panel, tells WebMD.
Conclusions Disputed
Merck wants to market 20 mg Mevacor tablets for men over 45 and women over 55 who are at moderate risk a of heart attack because of LDL levels between 130 and 170.
But company officials and agency scientists presented wildly different interpretations of data questioning whether average patients can determine on their own if they qualify for the drug.
Prescription statin drugs should not be used in pregnant women because of a potential risk of harm to the fetus seen in animal studies. The drugs also carry a risk of liver toxicity and the dangerous muscle disorder rhabdomyolysis. Other available statin drugs include Lescol, Lipitor, Pravachol, and Zocor.
One severe allergic reaction but no cases of liver damage or rhabdomyolysis were seen in a Merck study of 1,061 patients who took Mevacor for an average of six months without a prescription, leading the company to conclude that over-the-counter use carries no unique safety risks.
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