The Food and Drug Administration is cracking down on companies that make and distribute unapproved prescription ear drops.
The agency said there are 16 kinds of drops, known as otic products that claim to relieve ear pain, infection and inflammation, but contain ingredients that have not been approved as safe and effective, including benzocaine and hydrocortisone.
The FDA said the unapproved prescription otic drugs are being given to young children suffering from ear infections and other conditions that cause ear pain and swelling. The drops have reportedly caused allergic reactions in ears and eyes, as well as on faces, necks and in mouths. Itching, stinging, burning and irritation of the ear has also been reported.
“Using a product that has not been shown to be effective, especially when we have evidence of some safety concerns, is risky to the public health,” the FDA said in a news release.
The agency said manufacturers have been notified and will be subject to enforcement actions, including criminal proceedings if they do not stop making and/or selling the products.