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.