The Food and Drug Administration has issued a warning
that some common over-the-counter acne treatments can cause severe irritation or
even life-threatening allergic reactions.
The products — available as gels, lotions, face washes,
solutions, cleansing pads, toners and face scrubs — contain benzoyl peroxide or
salicylic acid. They are marketed under brand names such as Proactiv,
Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear.
The FDA says the potentially serious allergic reactions
such products can cause — throat tightness, shortness of breath, wheezing, low
blood pressure, fainting, or collapse — are not listed on their labels along
with the less serious reactions that do appear there, such as dryness, itching,
burning, peeling, redness and slight swelling.
Between 1969 and February 2013 the FDA received 131
reports of serious allergic reactions to these types of acne
products in people ages 11 to 78. Though no deaths were reported, 44 percent
of the patients required hospitalization, the FDA noted in a statement, adding that it will continue to monitor
the situation. The agency is asking manufacturers to include label information
advising first-time users on how to test the product’s safety.
While the cases of hypersensitivity reaction to the
acne products are rare, the potential for the reactions to be life-threatening
is what led to the FDA's warning, according to a spokeswoman.
"It is important for consumers and healthcare
professions to be aware of this potential serious adverse event so they can make
informed decisions about using the products," FDA press officer Stephanie Yao
said in an emailed statement to Dermatology Times. "Also,
consumers should be aware that the severity and potential consequences of these
hypersensitivity reactions may be distinct from the application site reactions,
which consumers may more readily associate with product use and for which
warnings already exist on product labels.
"As the FDA continues to monitor and evaluate this
safety issue, the agency will work with industry with regard to any future
labeling changes that would address the risk of serious hypersensitivity
reactions," Ms. Yao said.
