Advisory Committee Rejects OTC Mevacor

December 14, 2007

A joint FDA Nonprescription Drugs and Endocrinologic and Metabolic Advisory Committee voted 10–2 with one abstention recommending the FDA not approve Merck’s OTC-switch application for statin Mevacor.

The meeting was the third held to consider the Mevacor (lovastatin) switch application.

The committees also voted 11–2 that a Merck consumer self-selection study did not demonstrate that OTC consumers could appropriately make a decision on whether to take the drug.

Eileen Craig, a reviewer for the FDA’s Division of Metabolism and Endocrinology Products, asked the committees whether they were concerned that some patients on more potent statins, such as Pfizer’s Lipitor (atorvastatin calcium) and AstraZeneca’s Crestor (rosuvastatin calcium), would switch to OTC Mevacor.

More than 30 percent of participants in studies supporting the switch application who were taking lipid-lowering therapies said they thought it would be appropriate for them to take Mevacor, the FDA said. Of those subjects, 55 percent indicated they would replace their current medication with OTC Mevacor.

Craig also asked whether the committees were concerned that 28 percent of subjects identifying themselves as eligible for OTC Mevacor would add it to their current treatment regimen, thereby increasing their risk of side effects such as myopathy or rhabdomyolysis.

The company said the addition of Mevacor would have only a marginal effect on cholesterol levels and consumers would not likely continue taking the drug after their first cholesterol test.

Committee member Thomas Pickering, an assistant professor of medicine at Columbia University Medical Center, said the OTC Mevacor would meet an unmet medical need and that he was not concerned with consumers being able to appropriately decide to use the product.