FDA Advisory Committee Looks at Efficacy and Labeling of OTC Tinea Pedis Products

On May 2, 2004, a joint meeting of the Nonprescription Drug Advisory Committee and the Dermatologic & Ophthalmic Drugs Advisory Committee was held to review labeling issues for the treatment of interdigital tinea pedis. Confusion regarding clinical trial methods (especially end-points), a large number of lack-of-efficacy reports (based on March 2004 FDA Adverse Event Reporting System data) and reports of cellulitis were the primary concerns. The article indicates that many manufacturers have not followed previous FDA recommendations for clinical trial criteria and the FDA is looking for ways to "ensure products are safer, cleaner and more effective." A brief discussion regarding efficacy results reminds the reader that patient misuse (primarily lack of adherence to therapy for sufficient time) also plays a role in the lack of efficacy reports. The joint committee's new recommendations to manufacturers are listed below.

1. Conduct dose-response studies for multiple concentrations of active ingredient.
2. Agree on the lowest acceptable rate of cure that is meaningful.
3. The phrase "Cures most athlete's foot" is misleading and should be removed.
4. Add information regarding symptom relief and delay in response relative to end of treatment.

The committee discussed but did not make a decision on whether to single out patients with diabetes or immunocompromised systems for a warning regarding an increased risk of secondary infections. http://www.medscape.com/viewarticle/479012?src=search Return to Top