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Over the counter? No

December 22, 2008|Erin Cline Davis

Statins are available only by prescription in the U.S. -- in contrast to the United Kingdom, where in 2004 a low dose (10 milligrams) of simvastatin, sold as Zocor Heart Pro by Merck & Co., was approved for sale without a prescription, although still not exactly over the counter. Patients must consult with a pharmacist to determine whether they qualify for statin treatment.

Merck has thrice applied for, and thrice been denied, Food and Drug Administration approval to sell a 20-milligram dose of lovastatin, called Mevacor Daily, over the counter in the U.S.

In the most recent denial, issued in December 2007, an expert panel advised the FDA that Mevacor could be a safe and effective option for lowering cholesterol but that there was not enough evidence that consumers could safely judge whether they were good candidates for statin therapy.

Members of the panel also expressed concern that people at high risk for heart disease might choose to bypass doctors in favor of a low-dose statin available over the counter, resulting in too little treatment.

Some physicians are enthusiastically in favor of over-the-counter statins. Dr. Antonio Gotto, dean of Weill Cornell Medical College in New York City, says he has supported such a move every time Merck has made its application and is still in favor of it.

Though he says that he does not think everyone should be on a statin and that people should try changes in diet and exercise before turning to a medication, he notes that the recently reported JUPITER trial (see main story) showed that the drugs could provide a definite benefit to some people with low cholesterol.

"I think they are one of the safest classes of drugs that have been approved," he says.

But Dr. Mary Malloy, co-director of the adult lipid clinic and director of the pediatric lipid clinic at the UCSF Medical Center, says that despite the JUPITER results, she would be opposed to granting a statin over-the-counter status.

"It is, after all, a drug," she says. "A physician needs to help a patient determine if they need it. And someone needs to follow them to make sure they don't have side effects."

-- Erin Cline Davis

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