FDA rejects sale of over the counter statinsBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7484.164-d (Published 20 January 2005) Cite this as: BMJ 2005;330:164
- Owen Dyer
An expert advisory panel at the Food and Drug Administration last week rejected a proposal to permit over the counter sales of Merck's statin lovastatin (Mevacor), arguing that the risk of the drug could outweigh its benefits in many potential users.
If Merck's proposal had been accepted, lovastatin would have become the first long term preventive treatment to make the switch from prescription to over the counter status in the United States.
The decision is not binding, but the FDA hardly ever rejects the opinions of its own expert advisers. Although several leading cardiologists had publicly backed the proposal, the advisory panel voted against approval by a resounding margin of 20 to 3.
During the panel's public testimony session, several of the members who eventually voted against …