On 14 December 2007, two advisory committees of the US Food and Drug Administration (FDA) voted against allowing lovastatin 20 mg to be sold without a prescription (over the counter, OTC).
At the joint meeting of the Nonprescription Drugs and Endocrinologic and Metabolic Drugs advisory committees, members discussed the need for more research on effectiveness and safety, and for caution before any decision. Selling these drugs without a prescription would put the burden on patients to decide whether they need them, and could increase side effects.
The proposed label had been revised to help consumers understand the medicine and to strengthen warnings about pregnancy and muscle damage. This was the third time the committees had considered lovastatin, after meetings in 2000 and 2005.
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