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FDA wants to make sure that the next time your child has ear pain requiring a prescription drug, the product has been approved by FDA as safe and effective.
That’s why FDA is notifying companies to stop marketing 16 unapproved prescription drugs labeled to relieve ear pain and swelling. These ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by FDA for safety, effectiveness and quality.
For years, health care providers have prescribed—and pharmacies have sold—these drug products whose labels did not disclose that they weren’t approved by FDA.
“If we don’t know whether these drugs have any benefits, we should not accept any possible risk of side effects,” says FDA’s Charles E. Lee, M.D.
Why FDA Is Taking This Action
FDA is taking this action under its Unapproved Drugs Initiative, which seeks to protect consumers from drugs that are not proven safe, effective and of high quality.
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. FDA has received a few reports that these products had caused local allergic reactions of the ear, eye, face, neck and mouth. They can also cause itching, stinging, burning and irritation of the ear.
Unapproved prescription ear drug products containing these ingredients are covered by FDA’s action:
- benzocaine and antipyrine
- benzocaine, antipyrine and zinc acetate
- benzocaine, chloroxylenol and hydrocortisone
- chloroxylenol and pramoxine
- chloroxylenol, pramoxine and hydrocortisone
The quality of these drugs is uncertain. When FDA approves a drug, we review the manufacturing processes to ensure that the drugs are of consistent quality and purity, Lee says. That’s not the case with these unapproved ear drops.
What’s especially worrisome is that some of these products are prescribed for young children and infants, the population most susceptible to ear infections.
“It’s very basic—drugs that are used in children should be tested in children,” Lee says. “These products haven’t been shown to be effective in anyone, and there’s no proof that they work.”
FDA-Approved Alternatives Available
Parents and other consumers still will have many other treatment options.
FDA’s action affects only a small percentage of the drugs prescribed to treat pain and swelling that result from otitis media (middle ear infections), otitis externa (outer ear infections), and excess buildup of earwax. There are many FDA-approved drugs for middle and outer ear infections, plus other over-the-counter (OTC) products that are effective for prevention of swimmer’s ear and earwax buildup.
“We want consumers, doctors, health care providers and pharmacists to know about this problem and that they have better choices,” Lee says. “It’s not a difficult change. Use the products that we know are safe and don’t pose a danger to your health.”
What to Do Next
If you think you’re using unapproved prescription ear drops, contact your health care provider to discuss alternatives. FDA’s action will not affect legally marketed ear drops.
If you are experiencing side effects from unapproved products, consult your health care provider as soon as possible. FDA urges you to report that information online. You or your health care provider can also report an illness or injury related to the use of these products by calling 1-800-FDA-1088.