Topical Acne Products May Lead to Serious, Deadly Reactions. Over-the-counter (OTC) topical acne products may lead to rare, but very serious, hypersensitivity reactions, according to a Drug Safety Communication issued by the U.S. Food and Drug Administration (FDA). The products are sold under a variety of brand names, including:
- Clean & Clear,
- Store brands
Products may be sold in a variety of delivery systems, such as:
- Face washes
- Cleansing pads
- Face scrubs
Our firm is investigating claims against the makers of these OTC topical acne treatment products for injuries individuals suffered. Some people who have used these creams have suffered serious allergic reactions that are not indicated in product labels and which are more serious than skin irritations.
Serious Reactions Require Emergency Medical Attention
Federal regulators warn that topical acne products may cause potentially life-threatening allergic reactions or severe irritation. Should an individual experience hypersensitivity reactions, emergency medical attention must be immediately sought. Hypersensitivity and other reactions may occur within minutes and may also occur one day, even longer, after use and include:
- Difficulty breathing
- Feeling faint
- Fainting, collapse
- Swelling of the eyes, face, lips, or tongue
- Tightness of the throat
- Shortness of breath
- Low blood pressure
- Itching of the face or body
Federal regulators stress that these serious hypersensitivity reactions are not the same as local skin irritations that may occur at the product application site. Local skin irritations may include redness, burning, dryness, itching, peeling, or slight swelling, and these symptoms are already included 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 review revealed 131 reports of serious allergic reactions in response to use of topical acne drugs in the past 44 years. While no cases resulted in death, 44 percent of the people affected required hospitalization. Most of the reactions occurred within as short as minutes to as long as 24 hours following first-time use of the products and involved people ages 11 to 78.
The FDA indicated that, based on the information it received in reports provided to the agency, it is unable to determine if these serious hypersensitivity reactions were caused by the acne products’ active ingredients, benzoyl peroxide or salicylic acid; the products’ inactive ingredients; or by a combination of both the products’ active and inactive ingredients.
The FDA recommends that prior to first-time use of an OTC topical acne drug product that a small amount of the product be applied to one or two small affected areas for at least three days to ensure no hypersensitivity symptoms develop. If no discomfort occurs, then the product may be used in accordance with the product’s Drug Facts label.
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