FDA: Some OTC Topical Acne Treatments May Cause Serious Reactions

Acne_Treatment_Cream-293x300The U.S. Food and Drug Administration (FDA) just issued a Drug Safety Communication concerning over-the-counter (OTC) topical acne treatment products that may cause rare, but very serious, even deadly, hypersensitivity reactions

The products are sold under a variety of brand names, including Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. The OTC topical acne treatment products may also be sold under store brands and are sold in a variety of forms, including, gels, lotions, face washes and scrubs, solutions, cleansing pads, and toners, to name some.

The potentially life-threatening allergic reactions or severe irritation may include the following symptoms:

  • Difficulty breathing
  • Shortness of breath
  • Low blood pressure
  • Feeling faint, fainting
  • Collapse
  • Swelling of the eyes, face, lips, or tongue
  • Tightness of the throat
  • Wheezing
  • Hives
  • Itching of the face or body

Should any of these hypersensitivity reactions be experienced, emergency medical attention must be immediately sought. These potentially dangerous reactions  may occur within minutes of application, but may also take place one day, even several days, after initial use. Federal regulators emphasize that these very serious hypersensitivity reactions are not the same as local skin irritations that may be experienced following product application and which may cause redness, burning, dryness, itching, peeling, or slight swelling. Local skin reactions are already discussed in the products’ Drug Facts labels.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” said Dr. Mona Khurana, medical officer at the FDA in an agency news release. “It’s important that consumers know about them, and that they know what to do if they occur.”

An FDA analysis revealed 131 reports of serious allergic reactions following use of topical acne drugs in the past 44 years; patients were 11 to 78 years of age. No cases were fatal; however, 44 percent of the people who suffered a serious allergic reaction required hospitalization. Most reactions took place within minutes to 24 hours after first-time use of the products.

According to the FDA, based on information it received it is unable to determine if serious hypersensitivity reactions were caused by the acne products’ active ingredients, which typically include benzoyl peroxide or salicylic acid. No determination was able to be made concerning the products’ inactive ingredients or if the reactions were the result of a combination of both the products’ active and inactive ingredients.

This entry was posted in Defective Products, Health Concerns, Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.