FDA challenges drug maker’s claims on athlete’s foot remedy
The maker of the antifungal cream Ertaczo (sertaconazole nitrate) received a violation letter from the FDA last week regarding misleading advertisements for the prescription medication, which is used primarily to treat interdigital tinea pedis — more commonly known as athlete’s foot.
While Johnson & Johnson claims the cream eliminates the infection that causes athlete’s foot, clinical trials have shown it to be only modestly effective against tinea. The ads included claims such as “Tinea Stops Here” and “Crush. Kill. Destroy.”
So, what exactly is athlete’s foot — and what medication is your best choice for treating it?
Athlete’s foot is a fungal infection that can lead to intense itching, cracked skin, scaling and redness. It can occur on wet skin especially between the toes, or on dry skin around the heels and rest of the foot.
Your best treatment option depends on the condition’s type and severity. In many cases, athlete’s foot can be treated effectively by over-the-counter topical medications like Lamisil AT, Micatin, Lotrimin AF or Tinactin.
For more severe cases or those that don’t respond to OTC remedies, prescription topicals are the next option. These include Naftin, Mentax, Monistat Derm, Lotrimin and Ertaczo.
When your athlete’s foot doesn’t respond to topical medications, your doctor may prescribe oral antifungal pills, such as Lamisil, Sporanox, and Diflucan.
Which treatment is best for you? There are a large number of antifungal medications on the market, with different active ingredients, so the options are many. One study did find that so-called allylamines (such as Lamisil and Naftin) cured more athlete’s foot infections than azoles (such as Ertaczo and Lotrimin).
As always, however, your best option is to consult with your doctor based on your individual symptoms.
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September 4th, 2009 at 5:57 pm
This article could be improved somewhat by mentioning along with the brand name, the generic in parentheses. That way, those that are unfamiliar with the products, would be able to figure out what exactly is being highlighted. As we well know in the OTC market, drugs marketed today as containing one ingredient could very well contain something else tomorrow.
In describing what causes Athlete’s Foot, it might be wise to mention the usual etiological suspects and how tinea pedis is different from the organisms for which the new drug was indicated.
Also, there is some doubt in one’s mind that itraconazole Sporonox would be used to treat Athlete’s Foot at several dollars a tablet.
After reading the linked article, it merely seems as if the company is being slapped for failing to get FDA-approved ads into print. Not such a bad idea to attempt to start policing the printed copy; there’s a lot that drug manufacturers must attempt to get away with if there is no policy in place to run the final draft by the FDA. You’d think that Johnson & Johnson would’ve not been involved in this kind of stunt, though. Must be someone new or change in leadership in the organization?