Committees reject OTC status for Tagamet, Rogaine - heartburn and baldness drugs not recommended for over-the-counter sale because of possible drug interactions - Brief Article

FDA Consumer, Oct, 1994

FDA advisory committees voted last July against a switch from prescription to over-the-counter (OTC) status for the heartburn drug Tagamet (cimetidine) and baldness treatment Rogaine (minoxidil 2 percent topical solution).

Meeting jointly, the agency's Nonprescription Drugs Advisory Committee and Gastrointestinal Drugs Advisory Committee rejected OTC use for Tagamet because of potential interactions with other prescribed drugs.

The nonprescription committee rejected an earlier try in 1993 by marketer SmithKline Beecham to switch Tagamet to OTC status on the basis of insufficient data.

In the case of Rogaine, the nonprescription committee recommended against granting OTC status based on the product's limited effectiveness and the panel's concern for safety of patients who may misuse the product or misdiagnose the reason for their hair loss. Rogaine is marketed by Upjohn Co.

FDA advisory committees are composed of experts from outside the agency. Committee recommendations play a major role in FDA decisions, although the agency is not bound to follow these recommendations.