The FDA Ponders Over-the-Counter Status for Two Cholesterol-Lowering Drugs
WebMD News Archive
Jul. 11, 2000 (Washington) -- Millions of Americans might soon have easier access to two powerful weapons against heart disease, the nation's leading cause of death.
Later this week, a committee of expert federal advisors will review and vote on whether to support the approval of over the counter applications for Merck's Mevacor (lovastatin) and Bristol-Myers Squibb's Pravachol (pravastatin), two cholesterol-lowering drugs that belong to a class of drugs called HMG CoA reductase inhibitors, or 'statins'. If the committee supports these applications, the drugs eventually could become available without a prescription.
Federal regulators previously have rejected the notion of selling cholesterol-lowering drugs over the counter, but some advocates believe the time has arrived.
More emphasis must be placed on the wider use of preventive measures, notes Jerome Cohen, MD, professor of cardiology at St. Louis University Medical School. At a recent public hearing aimed at determining what classes of drugs, if any, should be available over the counter, Cohen observed that the benefits of easier access clearly outweigh any potential side effects.
Elevated levels of bad, or LDL, cholesterol is a key risk factor in heart disease, and studies have shown that statins lower LDL cholesterol levels by as much as 60%, depending upon the dosage and drug formulation, he pointed out to FDA officials.
But the outcome of this meeting is anything but certain. To support their application, the sponsors of Pravachol and Mevacor will need to show that their drugs are safe and effective at lower doses, that consumers are able to self-diagnose their condition, and that the over-the-counter dose would not require follow-up tests, according to experts.
Consumers' diagnostic abilities can be addressed by conducting behavioral studies, counters the Consumer Healthcare Products Association, an organization representing makers of over-the-counter products. However, the question of whether these drugs are safe must be addressed through follow-up tests, says the American College of Cardiologists (ACC). Consumers should also have a reasonable expectation of improvement in cholesterol levels, for which there is no guarantee at these lower doses that would be sold over the counter, the ACC adds.
While the ACC will not take a position regarding any specific product, statins do require monitoring for potential liver damage, Edward Frohlich, MD, FACC, a representative of the ACC, recently cautioned FDA officials. Moreover, consumers will have no guarantee that these drugs are working without follow-up tests, he said at the recent FDA meeting, while noting that additional risk factors, such as a person's lifestyle, could be masked by their use of these products.
A wildcard in the statins' favor might be the continuing saga surrounding the dietary supplement Cholestin, which contains the same active ingredient as Mevacor. In 1998, the FDA banned its maker from importing the powder, but in February 1999, a federal judge ordered the FDA to lift its ban, leading to the suggestion that there should be a proven alternative available to consumers.