FDA warns of serious allergic reactions with acne products (updated)

Rohto Pharmaceutical

25/06/2014 19:29

(Adds FDA comment, adverse event details) 
    June 25 (Reuters) - 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. (http://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 
formulations.   
     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) 
 ((esha.dey@thomsonreuters.com)(within U.S. +1 646 223 8780, 
outside U.S. +91 80 6749 1130)(Reuters Messaging: 
esha.dey.thomsonreuters.com@reuters.net)) 
 
Keywords: FDA WARNING/