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FDA mulls verdict on statin sales


The Food and Drug Administration (FDA) is deciding if it should approve Mevacor (lovastatin) as the first over-the-counter statin in the US.

Merck is trying for a third time to get the regulator to green light a low-dose version of the cholesterol-busting drug which can be sold in pharmacies.

The manufacturer argues that of the 20 million Americans with moderately high cholesterol who qualify for statin treatment, only six million currently receive it.

And it believes that a nonprescription option will encourage many more to give it a try.

“This is a real opportunity,” Merck’s Dr Edwin Hemwall told the FDA panel.

He acknowledged that selling Mevacor over the counter will mark a major shift in health policy, but he added: “This is a significant step. We commit to do it responsibly.”

However, FDA scientists said a Merck study of almost 1,500 potential customers who read warnings labels to decide if they were proper candidates found 25% wrongly believed they would benefit.

And 30% of people with heart disease, diabetes or history of stroke who took part in the trial wanted to buy the drug, even though they need to be assessed by a doctor.

Copyright © PA Business 2007



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