The Verdict Is In- - -Mevacor® Will Not Be Sold OTC

A Food and Drug Administration Panel voted 20 to 3 on January 14th of this year not to allow the statin, Mevacor® (lovastatin) to be sold as an over-the-counter (OTC) drug. Merck, the company that manufactures the popular statin drug, cited that if individuals with high cholesterol levels were able to have better access to the drugs, the risk of heart disease and other risk factors associated with high cholesterol levels would be lower.

A study performed by Merck and published in the November issue of the American Journal of Cardiology indicated that patients would appropriately chose the OTC medications. These results, and the rise of obesity and heart disease in the United States, looked favorable for the US to have an OTC cholesterol medication. Great Britain launched its first OTC statin drug, simvastatin, late last year with mixed criticism.

However, when the studies were reviewed again by the FDA panel, it was noted that only 10% of the individuals who selected Mevacor® actually met the criteria to be on the drug. The FDA fears that, if Mevacor® is available to patients OTC, patients will not comply with the directions, recognize potential side effects, and gain follow up treatment from their health care practitioner concerning their cholesterol levels. Additionally, critics of the OTC conversion of statin drugs voiced their concerns of individuals taking the drug who do not need to take them, which would include pregnant women, children, and individuals who are not at risk for heart disease.