Drug companies must stop producing or marketing unapproved prescription ear drops, the U.S. Food and Drug ordered Wednesday. The drops are often used to treat childhood ear infections but are not FDA-approved and may not be safe.
Even medical professionals may not realize that they’ve prescribed an unapproved drug, the FDA said, because the label doesn’t say so.
“These products haven’t been shown to be effective in anyone, and there’s no proof that they work,” said FDA medical officer Charles E. Lee in a statement.
One infant died following a blood reaction to the unapproved ingredient benzocaine, according to the FDA report published Wednesday. Less serious reactions include hypersensitivity, itching, stinging, burning and irritation.
The drops are prescribed to treat ear infections, fluid, inflammation and excessive earwax. But they contain ingredients that are not approved for safety, effectiveness and quality. The products may be contaminated or provide the wrong dose.
“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,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
Ear drops containing these ingredients are not approved by the FDA:
benzocaine and antipyrine
benzocaine, antipyrine and zinc acetate
benzocaine, chloroxylenol and hydrocortisone
chloroxylenol and pramoxine
chloroxylenol, pramoxine and hydrocortisone
The action doesn’t affect products that are FDA-approved or those that are legally sold over-the-counter. Parents or patients who think they’ve been prescribed an unapproved drug should contact their healthcare provider.
Gavin Stern is a national digital producer for the Scripps National Desk.