FDA says statin cannot be sold “over the counter”BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7255.198/b (Published 22 July 2000) Cite this as: BMJ 2000;321:198
- Scott Gottlieb
- New York
An advisory committee to the US Food and Drug Administration rejected a request by the US pharmaceutical company Merck for its cholesterol lowering drug lovastatin to be sold “over the counter” (without a doctor's prescription).
In issuing the rejection, the panel said no evidence showed that it could be used safely and effectively in a consumer setting.
Lovastatin, introduced in 1987, works by inhibiting hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase, which stimulates the production of cholesterol in the …