The New York Times is reporting that advisors to the federal Food and Drug administration have voted 10 – 2 against recommending the approval of an over-the-counter version of the prescription drug Mevacor. The drug, made by Merck, is used for treating high cholesterol. If the FDA accepts the advisors’ recommendation — which it typically does — this will the third time it has rejected a non-prescription version of Mevacor since 2000.
The reason for the rejection? Too many people would use the drug — even those at high risk for side effects. As FDA advisor and Harvard Medical School member Dr. William Shrank put it: “The patients couldn’t figure out whether the drug was for them. ”
25% of people in the advisors’ study said they would buy the drug, even though they didn’t qualify as “high risk ” for a heart attack — meaning they would put themselves at risk for the drug’s side effects without receiving its benefits.
Among people considered high-risk for a heart attack, 30% said they would take the non-prescription of the drug. According to the FDA advisors, these high-risk patients should be under doctor supervision — not relying on an over-the-counter medication.
Heart disease is the number one cause of death in the U.S., according to the American Heart Association.