Unapproved Children’s Ear Drops May Not Be Safe or Effective, FDA Warns

Federal health regulators are warning that a number of prescription ear drops for children are being sold by pharmacies nationwide that have never been approved. Following at least one death and a number of adverse events, these unapproved children’s ear drops may pose potential safety concerns. 

The FDA published a federal register notice (PDF) this week, announcing that it plans to take enforcement action against the makers of at least 16 prescription ear drop products sold for children, known as otic products.

The children’s ear drops are commonly labeled as prescription drugs to relieve ear pain, inflammation and ear infections. However, the labels fail to warn that the drugs have been released without FDA approval.

The FDA warns that these drugs are not proven to be either safe or effective, and have never been tested on children. In addition, since they were made without FDA approval or oversight, they could be contaminated or poorly manufactured or may not even contain the active ingredients they claim to contain.

According to the FDA, at least five adverse event reports have been linked to unapproved prescription ear drop products, including at least one case of a serious blood disorder known as methemoglobinemia, which resulted in the death of an infant. Other reports involve allergic reactions such as angioedema of the ear, eye, face, neck, and mouth.

The FDA has posted a Consumer Update website to explain the risks to parents and caregivers.

The unapproved otic products have one of the following combinations of active ingredients:

• Benzocaine
• Benzocaine and antipyrine
• Benzocaine, antipyrine, and zinc acetate
• Benzocaine, chloroxylenol and hydrocortisone
• Chloroxylenonl and pramoxine
• Chloroxylenol, pramoxine, and hydrocortisone

“Taking enforcement actions against these unapproved products will protect patients from unnecessary risks,” Cynthia Schnedar, director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research said in a press release. “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.”

Companies selling the products have been ordered to stop immediately, and could face other enforcement actions.