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
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 liver. The drug is currently prescribed to reduce cholesterol levels for patients whose total cholesterol level is greater than 240 mg/dl (6.2 mmol/l) and to slow the progression of coronary atherosclerosis. The drug's manufacturer wanted to market a 10 mg dose over the counter to people without heart disease who have a total cholesterol of 200–240 mg/dl (5.2-6.2 mmol/l) and a low density lipoprotein cholesterol level of 130 mg/dl (3.4 mmol/l) or higher.
To support its application for selling lovastatin over the counter, Merck presented four clinical studies, including one five year, placebo controlled trial of 6605 adults, ostensibly representing the potential population for over the counter sales. That study, known as the AFCAPS/TexCAPS trial, showed that the use of 20 mg or 40 mg lovastatin over five years reduced the risk of a first coronary event by about 37%, compared with placebo. The study also showed that lovastatin reduced the risk of unstable angina by 32% and reduced the need for coronary angioplasty by about 33%.
The FDA reviewers observed that the clinical trials submitted for approval tested a 20 mg and 40 mg dose rather than the proposed 10 mg dose and that the prescription dose required professional monitoring for signs of liver toxicity, as well as occasional adjustment for optimal effectiveness.
The panel's chief reviewer, Dr Mary Parks, said that there were uncertainties regarding consumers' ability to use an over the counter version of lovastatin safely and effectively. She noted that some consumers might unilaterally decide to take the equivalent of a prescription dose, which raised the safety issues facing the prescription dose, including liver toxicity.
The committee said that, although there was evidence that the over the counter dose would lower low density lipoprotein cholesterol levels, no evidence existed that an over the counter version of lovastatin would provide a clinical benefit in this low risk population.
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