(Adds FDA comment, adverse event details)
June 25 The U.S. Food and Drug Administration
warned on Wednesday that popular acne products sold
over-the-counter under brand names such as Proactiv and
Neutrogena can cause rare but serious and potentially
life-threatening allergic reactions.
The FDA said consumers should stop using their topical acne
product and seek emergency medical help if they experience
hypersensitivity reactions such as throat tightness, difficulty
in breathing, feeling faint or swelling of the eyes, face, lips
or tongue. (1.usa.gov/TwSCNt)
The agency said non-prescription products containing the
active ingredients benzoyl peroxide or salicylic acid and
marketed under brands such as Proactiv, Neutrogena, MaxClarity,
Oxy, Ambi, Aveeno and Clean & Clear, as well as store brands,
were of concern.
The agency said it has received 131 reports of such
hypersensitivity reactions from consumers or manufacturers, with
the majority since 2012.
The hypersensitivity reactions may occur within minutes to a
day or longer after product use, the FDA said. It noted these
serious allergic reaction differ from local skin irritation
reactions mentioned on most of the products' labels.
"There is currently no mention of the possibility of these
very severe allergic reactions on the product labels," Mona
Khurana, a medical officer at FDA said in a statement.
The products are available as gels, lotions, face washes,
solutions, cleansing pads, toners, face scrubs and other
The FDA said new users of topical acne products should use
a small amount on one or two affected areas of the skin for
three days to test for sensitivity reactions.
(Reporting by Esha Dey in Bangalore and Bill Berkrot in New
York; Editing by Maju Samuel and Meredith Mazzilli)