An advertisement for Johnson & Johnson’s (JNJ) Ertaczo, a product to treat the fungal infection known as athlete’s foot, makes unproven claims about the medicine’s effectiveness and omits key information about risks associated with the product, federal regulators said on Wednesday.
The Food and Drug Administration said Johnson & Johnson used “misleading” information and did not mention certain risks in a medical journal advertisement for its athlete’s foot cream Ertaczo.
In an Aug. 21 letter released by the FDA Wednesday, the agency said the journal advertisement broadens the approved indication, contains unsubstantiated effectiveness claims about the product, and omits important risk information. Also, the FDA said J&J failed to submit the journal advertisement under current FDA regulations.
The company has until Sept. 4 to respond to the FDA letter.
“We have received an untitled letter from the FDA, which we are currently reviewing, and are in the process of preparing our response to the FDA,” said Marc Boston, a spokesman for J&J’s Ortho Dermtalogics unit, in a statement.
The FDA said the promotional materials suggested the drug is useful in a broader range of conditions than has been demonstrated. Also, the FDA cited an omission of safety information.
“Although the journal ad presents some of the adverse events associated with Ertaczo, it fails to include the contraindication or any of the warnings and precautions information for this drug product,” the FDA said. “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 asked the company to immediately cease the advertisement.
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