January 24, 2021

Volume XI, Number 24

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January 21, 2021

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FDA Warns of Rare but Potentially Severe Side Effects in Acne Drug Products

On June 25, 2014, the U.S. Food and Drug Administration (FDA) warned of rare but potentially serious allergic and hypersentivity reactions with certain over-the-counter acne drug products. The agency’s announcement applies to those products containing benzoyl peroxide or salicylic acid. According to the agency, there is uncertainty as to what is specifically causing the side effects and whether they are caused by the active ingredients, inactive ingredients, or a combination of both. What is known, however, is that from 1969 through January 2013, 131 adverse reaction events have been reported to the FDA. Although there is no reported event that resulted in death, 44 percent resulted in hospitalization.

Warnings and Precautions

If your company manufactures such products, it is hopefully already in full compliance with the final monograph for acne drug products which requires specific warnings and statements. The FDA is now suggesting that manufacturers also warn new users to first test the acne product on a small area of skin for three days before using as directed. Accordingly, it is the time to (1) audit your labels to make sure you are in fact in compliance with the final monograph as it is likely more attention will be given to such products in the coming months, and (2) update your labels with this new precaution.

Read the FDA’s complete safety announcement here.

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©2020 Greenberg Traurig, LLP. All rights reserved. National Law Review, Volume IV, Number 183
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