BY | June 26, 2014

FDA acne drug alert WAARNNS of life threatening allergic reactions. FDA has asked people to try it first lightly before full use.

 

The Food and Drug Administration (FDA) has warned that the using certain acne treating products that contains the active ingredients benzoyl peroxide or salicylic acid can root unusual but severe and probably life-threatening allergic reactions or vicious irritation.

 

An active ingredient is the element that formulates the medicine efficient against the disease or condition it is treating. The acne products that are sold over-the-counter (OTC) and applied on the skin (topical) are to watch out for, warns FDA.

acne fda  warning

Serious allergic symptoms vary from the less risky irritations previously mentioned in the products’ Drug Facts labels that comprises of burning, dryness, itching, peeling, redness, and slight swelling where the medicine is applied.

 

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

 

The products of apprehension are “Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean Clear, and store brands,” the FDA revealed. The products are offered as “gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.”

 

Those who experience any of the symptoms such as “throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue,” after applying the product then they should immediately stop using it, warns FDA.

 

“Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label,” the FDA advised.

 

“FDA will continue to monitor closely and evaluate this safety issue,” Khurana said. The agency is also encouraging manufacturers to use the drug label to advise consumers how to test the product’s safety before using it for the first time.

 

FDA reported that it has released a Drug Safety Communication (DSC) to notify both consumers and health care professionals of the prospective hazards of such products.

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