OTC Mevacor Label Illustrates New Approach Toward Approval

Over-the-counter Mevacor label features marked differences from J&J/Merck’s proposal for 10 mg lovastatin in 2000. More specific directions reflect 20 mg dose as well as narrower range of potential users; 30% of U.S. adults could be candidates for OTC statins, researcher says.

Proposed labeling for Johnson & Johnson/Merck's actual-use trial for over-the-counter Mevacor (lovastatin 20 mg) directs individuals to obtain follow-up cholesterol testing sooner than did the firm's 2000 proposal for the switch.

The Consumer Use Study of OTC Mevacor (CUSTOM) label instructs consumers to seek testing after six weeks of treatment and to discontinue the medica­tion and see a physician if their LDL cholesterol exceeds 129 mg/dL.

If the consumer's cholesterol is below 129 mg/dL, the statin is "working," the label states. The consumer should "keep taking [Mevacor OTC] daily and test your cholesterol once a year."

The label instructs consumers to eat a healthy diet and to exercise, and are cautioned that if they stop taking the drug, their "cholesterol will go back up."

FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees will meet Jan. 13-14 for a joint session that likely will focus on a statin switch (¹ (Also see "CUSTOM Study: Mevacor OTC Data May Be Boon For Switch Prospects" - Pink Sheet, 10 Nov, 2004.).

Labeling for lovastatin 10 mg in J&J/Merck's 2000 Rx-to-OTC switch application advised the consumer to test his or her cholesterol "after about eight weeks," and to continue using the product in combination with a low-fat diet and exercise "or your cholesterol may go back up."

Lovastatin 20 mg targets a narrower range of potential users who have LDL cholesterol in the 130-170 mg/dL range, plus one or more cardiovascular risk factors (e.g. smoking, high blood pressure and HDL cholesterol below 39 mg/dL). By comparison, lovastatin 10 mg labeling targeted consumers with LDL above 130 mg/dL without mentioning specific risk factors.

This more specified target group still could represent a sizeable percentage of the U.S. population, Thomas Pearson, MD/PhD, University of Rochester, notes in a November American Journal of Cardiology supplement.

Based on data from the third National Health & Nutrition Examination Survey (1988-1992), Pearson estimates approximately 30% of U.S. adults could be candidates for OTC statins, assuming the absence of coronary artery disease and total cholesterol in the 200 to 239 mg/dL range.

Pearson concludes this group "would eventually contribute to approximately one third of CAD cases" if untreated.

- Daniel Healey