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FDA Targets Unapproved Eardrops


For years, physicians may have been unknowingly prescribing unapproved eardrops used to treat ear pain and swelling, to parents for their children’s ear aches. The drugs have not been evaluated for safety, quality and effectiveness says the U.S. Food and Drug Administration (FDA).

The agency notified the drugs' makers to stop marketing the drops following a few reports of local allergic reactions of the ear, eye, face, neck and mouth. The drops can also cause itching, stinging, burning and irritation of the ear, according to an FDA news release.

"If we don't know whether these drugs have any benefits, we should not accept any possible risk of side effects," said the FDA's Dr. Charles Lee in the news release.

The FDA did not release the names of the companies or the medications involved, but did note, "unapproved prescription otic [ear] drug products containing the following ingredients are covered by this action:

·      Benzocaine;

·      Benzocaine and Antipyrine;

·      Benzocaine, Antipyrine, and Zinc acetate;

·      Benzocaine, Chloroxylenol and Hydrocortisone;

·      Chloroxylenol and Pramoxine;

·      Chloroxylenol, Pramoxine, and Hydrocortisone.

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

The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.  The FDA’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use, the agency said.

The FDA recommends that you check with your doctor if you think your child may have been prescribed one of these products or has exhibited side effects. You can ask for an alternative medication that has been FDA approved.

Sources: Margaret Farley Steele,

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