What Your Doctor May Not Be Telling You About Ertaczo
If you’ve ever had athlete’s foot, you know how annoying it is and how much someone might want to get rid of it. There are many remedies for this fungal infection, both prescription and over the counter. If you’re considering the prescription remedy Etraczo, there are some things you should know about this medication.
What is Ertaczo?
Ertaczo is a treatment for tinea pedis, commonly known as athlete’s foot, approved for sale by Johnson and Johnson in the United States in 2003.1
Does Ertaczo work? Are advertising claims about it true?
In 2009, the FDA issued Johnson and Johnson a warning letter regarding a print ad for Ertaczo that made unsupported claims about what Ertaczo could treat and left out warning and risk information.2
Drug companies are required to submit advertising and marketing materials to the FDA for review. Johnson and Johnson waited six months to submit this ad to the FDA for review.
The ad claimed Ertaczo “Wipes Out Tinea,” but Ertazco’s proven rate of complete cure in two studies was only between 13.1% and 27.2%.
The also claimed that Ertaczo “wipes out tinea with a three-pronged attack” that included a “fungicidal” and “anti-itch,” but the studies it cited to support those claims do not support them. Ertaczo does not contain an anti fungicide which is effective against athlete’s foot and it doesn’t contain any ingredients shown to reduce itching in humans. 2
Besides unsupported claims, the ad omitted or minimized required information on contraindications and required “Warnings and Precautions” information.
What should I go over with my doctor before deciding to take Ertaczo?
Some people may not be able to use Ertaczo and you should discuss with your physician whether it's right for you. Some people are sensitive to antifungals and they should not use Ertaczo. Ertaczo should never be used to treat opthalmic (eye), oral or vaginal fungal infections. The FDA suggests that your doctor examine the infected tissue by microscope or by culture before prescribing Etraczo.3
What if I’m already using Ertaczo?
Follow your doctor’s directions when using Ertaczo and talk to your doctor if you experience any irritation or your condition does not improve. If Etraczo is not right for you, your doctor can help you find another remedy.
Learn everything you can about Ertaczo before you start taking it.
Back to Articles
1 Food and Drug Administration Approval Letter, http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-385_Ertaczo_Approv.pdf. Etraczo is today sold in the United States by Valeant Pharmaceuticals International, Inc. http://www.ertaczo.com/
2 Food and Drug Administration Warning Letter (21 August 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM180194.pdf
3 Food and Drug Administration Approved Labeling (2003), http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-385_Ertaczo_Prntlbl.pdf