FDA questions if consumers can properly use over-t

(1)

Add Your Vote

FDA questions if consumers can properly use over-the-counter cholesterol drug

By LAURAN NEERGAARD , Associated Press

Last update: December 11, 2007 - 9:50 PM

The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it's sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.

Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.

A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be "a reasonably safe and effective" option _ if consumers used it as directed.

But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly _ 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded FDA's lead medical reviewer.

Moreover, about 30 percent of people who already were diagnosed with heart disease, diabetes or had had a stroke wanted to purchase over-the-counter Mevacor, people who need a doctor's care, the FDA documents say.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Merck argues that most people made the right decision on whether they should buy OTC Mevacor even if they missed some answers.

On Thursday, Merck will present its case to the FDA's independent scientific advisers, hoping they will recommend that Mevacor become the first in the family of cholesterol-lowering "statin" drugs to be sold in this country without a prescription. Twice before, FDA has said no.



Tags:	Cholesterol-Drug

Posted By:

Evmim

Posted Today

News

All Votes: 1

Bookmark

Report abuse

Comments (0) | Who voted on this story (1) | Email this story

UnitedProject.org Inc. (c) 2006-2010 All content published on UnitedProject.org is provided for informational purposes only and is not meant to substitute for the advice, diagnosis or treatment provided by your physician or other healthcare professionals. If you think you are experiencing a medical problem or an emergency please contact your physician, local emergency room or call 911. Healthcare benefits and discounts are not insurance and not intended as a substitute for health insurance. Except when other source is cited, all content posted by members is licensed under Creative Commons Public Domain License.

This site complies with the HONcode standard for trustworthy health information:
verify here.

Site last updated 02/10/12 - loaded in 0.0819 seconds

Website and Case Management Software powered by Paas Cloud Computing Platform