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Proposed over the counter cholesterol drug still under doubt

One of the concerns that the FDA has about the proposed over the counter cholesterol treatment, Mevacor Daily, is the fact that long-term compliance may be not be achievable. The FDA is worried about the fact that data only covers the first 18 months of use whereas it would take about 6 years of compliance to reduce the cholesterol to a good level. It is well known that other over the counter medications generally have very poor compliance even over several months or even weeks. The 18 month trial showed that compliance was maintained by over half of subjects during that time. Mevacor Daily was aimed to treat people with a cholesterol level of 130-170 mg/dL and one or more heart disease risk factors such as smoking, hypertension and HDL cholesterol under 39mg/dL. There are also concerns over whether people are capable of determining whether they need the drug or if they will follow the safety instructions. For example, the drug is inadvisable for people with kidney problems.

Source: summary of medical news story as reported by FDA Advisory Committee

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About: Proposed over the counter cholesterol drug still under doubt

Date: 14 January 2005

Source: FDA Advisory Committee

URL: http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Endocrinologic+and+Metabolic+Drugs/011305_Mevacor1/011305_MevacorR1.htm

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