Aclaris Snags Untitled Letter for Misleading Statements in TV Ad

June 28, 2019

Aclaris made misleading claims in a TV ad for its seborrheic keratosis treatment Eskata and failed to include details of potential side effects, CDER’s Office of Prescription Drug Promotion said in an untitled letter to the firm.

The ad—which originally aired in September 2018 and can be viewed on Aclaris’ Facebook and LinkedIn pages—didn’t mention serious risks spelled out in the warnings and precautions for the drug, a treatment for benign skin growths known as seborrheic keratoses.

Although the video mentioned Eskata’s most common side effects and invited consumers to visit the company’s website for full safety and prescribing information, this was no substitute for risk information on serious eye disorders that can result from unintended exposure to the drug and the potential for severe local skin reactions, the agency said.

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