FDA Warning for Unapproved Otic Ear Drops After Infant Death

July 1, 2015 — The FDA has warned manufacturers of otic ear drop to stop selling their products after complaints of allergic skin reactions and the death of an infant from a blood disorder.

The FDA says it has received at least five reports of allergic reactions, including angioedema (severe swelling) in the ear, eye, face, neck, and/or mouth. One infant died of methemoglobinemia, a serious condition affecting the body’s red blood cells, after receiving the drops. Other risks include painful burning, stinging, tenderness, swelling, and hypersensitivity reactions.

At least 16 types of ear drops contain ingredients that have not been approved as safe and effective. These ingredients include benzocaine, hydrocortisone, antipyrine, zinc acetate, chloroxylenol, and pramoxine.

These products are frequently given to children suffering from ear infections and other conditions that cause ear pain and swelling, such as “swimmer’s ear” and earwax.

The labels do not disclose the lack FDA approval, and health care professionals may not be aware of their unapproved status. The action does not affect FDA-approved prescription products or legally marketed otic products sold over-the-counter.

According to Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research:

“Taking enforcement actions against these unapproved products will protect patients from unnecessary risks. There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products.”

This is not the first time the FDA has linked benzocaine with serious side effects in children. In 2011, the agency warned that over-the-counter teething gels containing benzocaine could lead to methemoglobinemia. Those warnings were reiterated in 2012, when the agency said “Benzocaine and Babies: Not a Good Mix.”

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