The FDA's latest watch list includes over-the-counter (OTC) acne products containing benzoyl peroxide, salicylic acid, or both because of reported hypersensitivity and anaphylactic reactions. Both agents treat acne by exfoliating dead skin cells that clog pores. In addition, benzoyl peroxide kills bacteria and salicylic acid reduces inflammation. Skin reactions and allergic reactions have been associated with both agents. Being placed on the watch list does not mean the agents actually pose the reported health risks. Rather, it means that the FDA will investigate whether there is a causal connection. If the FDA does find a causal connection, the agency would consider a response such as gathering more information, amending the drug's label or requiring a risk evaluation and mitigation strategy.
The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs. Patients who have questions should contact their health care provider. FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.
[1] FDA Surveillance: "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2013", 1/27/2014.
The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs. Patients who have questions should contact their health care provider. FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.
[1] FDA Surveillance: "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2013", 1/27/2014.
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