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FDA Turns Down OTC Statins

Posting Date: 01/31/2005

A panel of experts for the FDA has turned down a high-profile prescription drug switch. This time it was for Mevacor (lovastatin), the first of the statin-type cholesterol-lowering medications.

Merck, the maker of Mevacor, wanted permission to sell the drug over the counter. Experts believe that many of the people who should take a statin drug to get their cholesterol down don?t do so. The cost of a physician visit and a prescription may be a barrier for some of these individuals at high risk of a heart attack.

Most cardiologists love statins. One we know has suggested that they should be in the water supply. Another recommended ?statin shakers? that would replace salt shakers in steak restaurants. Presumably the steak lover would shake some Lipitor or Zocor on his steak to counteract the effect of the saturated fat in the meat.

But the FDA panel turned thumbs down on OTC Mevacor because it concluded patients could not safely undertake such a program without medical supervision. This is in contrast to what regulators have done in Britain.

There, Zocor (simvastatin) is available without prescription. It is not exactly over the counter, though. A pharmacist must be consulted first and if the patient qualifies, then the drug can be dispensed from behind the counter. Many pharmacies in the United Kingdom have cholesterol-testing equipment available so that they can actually measure levels of blood cholesterol on the spot.

Behind-the-counter dispensing is not unusual in other countries. Some anti-inflammatory arthritis medicines require a pharmacist to counsel the patient and determine whether it will be safe for long-term treatment.

Emergency contraceptives are also available behind the counter in other countries and even some states in the U.S.

But the FDA has long resisted the concept. It insists on an all-or-none approach: for the agency, drugs are either safe enough for anyone to buy at a convenience store without a prescription, or they are so risky that only a doctor can guide their appropriate use.