Merck & Co., Inc. said certain US advisory panels urged the US Food and Drug Administration (FDA) to reject Merck's request to sell its cholesterol lowering drug Mevacor over the counter.
Mevacor is a prescription medicine that is approved in the US for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularisation procedures in healthy men and women with average or moderately elevated cholesterol levels.
The joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval of the over-the-counter (OTC) use of Mevacor (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.
"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.
The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.
According to the prescribing information, Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant.
Muscle pain or weakness in patients taking prescription Mevacor could be signs of a serious side effect. The most common adverse events reported with Mevacor 20 mg taken once daily were diarrhoea, flatulence, headache and myalgia.
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