J&J Warned About Misleading Ads for Athlete’s Foot Cream Ertaczo

The Food and Drug Administration has warned Johnson & Johnson about promotional materials placed in medical journals, which the agency says overstated the efficacy of the company’s Athlete’s foot cream Ertaczo.

Ads for Ertaczo contain “unsubstantiated efficacy claims” and omit important risk information about the anti-fungal product, according to an FDA warning letter sent to the company on August 21. Also, the ads were not cleared by the FDA before publication, as required by law, the FDA said.

Ertaczo, known generically as sertaconazole nitrate, is a topical cream approved by the FDA for treatment of interdigital tinea pedis – a condition more commonly called Athlete’s foot — in immunocompetent patients 12 years and older.

Ads Overstated Product’s Effectiveness

The medical journal ads in question included claims such as “TINEA STOPS HERE” and “Crush. Kill. Destroy,” which misleadingly suggested that Ertaczo is approved for use in all patients regardless of age or the nature of the bacterial organism causing the infection. Also, the claims overstate the effectiveness of the product, the FDA found.

The journal ads also were flagged for suggesting that Ertaczo has anti-itch properties, the FDA ruled. An article cited as evidence of the properties does not present any clinical data in human patients with Athlete’s foot, so the claim falls short of the substantial evidence required to support such claims of clinical benefits.

The Ertaczo ads also are misleading because they omit some risk information, according to the FDA.

“Because the advertisement omits these important risks, it misleadingly suggests that Ertaczo is safer than has been demonstrated by substantial evidence or substantial clinical experience,” the FDA said in the warning letter.

The FDA is asking Johnson & Johnson to immediately pull the offending ads for Ertaczo and to submit a written response to the warning letter on or before Sept. 4, 2009 stating whether the company plans to comply with the request.

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