July 1, 2015 — The manufacturers of 16 unapproved prescription otic ear drops have been told to stop selling their products after the FDA received five reports of allergic reactions and one infant who died from a rare blood disorder.
The five reports involved angioedema, a severe type of swelling in the ear, eye, face, neck, and/or mouth. The FDA also received one report of an infant who died from methemoglobinemia, a blood disorder linked to benzocaine. Other adverse event reports included burning, stinging, tenderness, swelling, and hypersensitivity reactions.
Ingredients in the unapproved otic ear drops include benzocaine, hydrocortisone, antipyrine, zinc acetate, chloroxylenol, and pramoxine.
The products are available with a prescription for children with ear infections, pain, swelling, “swimmer’s ear,” excessive ear wax, and other conditions. Doctors may be unaware that the products lack FDA approval because they are not labeled as such. The labels also do not mention all potential side effects.
Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, warned:
“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.”
Benzocaine has already been linked to methemoglobinemia in children. The FDA issued a warned for over-the-counter benzocaine teething gels back in 2011, and again in 2012 with the warning “Benzocaine and Babies: Not a Good Mix.”
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