FDA Warns Parents: Use Only Approved Prescription Ear Drops
By Marissa Rodriguez
Earaches are a common issue for many toddlers and young children, and many parents see no issue heading to the doctor for eardrops at the first signs of pain. But a new consumer update from the U.S. Food and Drug Administration (FDA) warns parents to double check that prescription to make sure the drug listed is approved by the agency.
As part of their Unapproved Drugs Initiative, the FDA is notifying companies to end their marketing of some 16 drugs that claim to soothe ear pain and swelling, but that have not been approved by the agency. The initiative aims to keep consumers safe from drugs that the agency hasn’t tested for safety, effectiveness and quality.
The agency is targeting some 16 unapproved drugs that contain benzocaine and hydrocortisone as their active ingredients. They are marketed to children, but haven’t been tested in that group or evaluated by the FDA.
“It’s very basic—drugs that are used in children should be tested in children,” says the FDA’s Charles E. Lee, M.D. “These products haven’t been shown to be effective in anyone, and there’s no proof that they work.”
While the FDA warns that they aren’t sure the drugs are effective, they have revealed that they have received some reports from consumers of the drugs causing adverse effects and allergic reactions “of the ear, eye, face, neck and mouth. They also cause itching, stinging, burning and irritation of the ear.”
What’s more, their labels don’t disclose that they are not approved, according to the report.
Parents should be relieved to know that several approved options will still be available to them including both approved prescriptions and over-the-counter medications.
The FDA urges people who suspect they are using unapproved eardrops to contact their health care provider to discuss a different treatment. Those experiencing negative side affects should contact their provider and report them to the FDA via their online system.
Read the FDA consumer update in its entirety.