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Merck & Co Inc's third bid for OTC sales of the cholesterol-lowering drug Mevacor (lovastatin) was rejected by FDA advisors. The company had previously tried for OTC sales in 2000 and 2005.
Too many of the wrong individuals would use the drug if it no longer required a prescription, FDA advisors concluded in a 10-2 vote December 13, 2007, against OTC sales. "The patients couldn't figure out whether the drug was for them," commented one FDA advisor, William Shrank, MD.
The advisors also were surprised by the results of a study of almost 1500 potential patients who wanted to purchase the drug even though they were bad candidates. Of the participants who wanted the medication, 25% did not have enough risk of heart disease to qualify. The patients (30%) at very high risk wanted Mevacor; these are patients who should be under the care of a physician.
Still, >30% of patients already taking the prescription cholesterol-lowering drug said they wanted an OTC version. Half of the group said they would stop the more potent drug in favor of lowdose Mevacor. To the agency's advisors, it raises questions about previously protected patients setting themselves up for a heart attack.
Merck's Edwin Hemwall, PhD, executive director for the company's worldwide nonprescription regulatory and scientific affairs, said after the meeting, "We are disappointed. We felt we presented a compelling case."
The FDA is not required to follow its advisors' recommendations but usually follows them.