In July, the Food and Drug Administration (FDA) issued a warning to use only FDA-approved prescription ear drops in children and to avoid using a number of commonly prescribed but unapproved ear drops that may potentially be harmful to some children.
According to the FDA Consumer Update, prescribing pharmacists and healthcare providers should avoid prescribing unapproved ear drug prescriptions that contain the following ingredients:
• Benzocaine and antipyrine;
• Benzocaine, antipyrine, and zinc acetate;
• Benzocaine, chloroxylenol, and hydrocortisone;
• Chloroxylenol and pramoxine; and
• Chloroxylenol, pramoxine, and hydrocortisone.
The FDA says that the efficacy of drugs with these ingredients to treat otitis media, otitis externa, or excessive wax buildup has not been proven, and, more importantly, it has received reports of adverse effects, including allergic reactions and one report of an infant dying after receiving drops.
David E. Tunkel, MD, director of pediatric otolaryngology at Johns Hopkins Hospital in Baltimore, shares the concern that patients may use medications for treatment of ear symptoms that may have limited or unproven efficacy, and that some are recommended by health professionals.
Despite the importance of pain management for children with ear infections, he emphasized that such treatment is not well studied. Referring to the 2013 American Academy of Pediatrics (AAP) guidelines on which he was coauthor, Dr. Tunkel said that there was little evidence in the literature to support the use of topical anesthestics and analgesics.
“Children who receive ear drops for pain control may not have optimal management of the pain and the infection, and side effects can occur,” he said. “Approved antibiotic ear drops such as ofloxacin or ciprofloxacin/dexamethasone preparations are useful for treating children with otitis externa or otitis media with otorrhea.”