The FDA Says it Will Take Action Against Companies That Manufacture and Sell Unapproved Ear Drops

The U.S. Food and Drug Administration (FDA) announced July 1 that the agency will take enforcement action against companies that manufacture and/or distribute unapproved prescription ear drop products (otis products) labeled to treat ear pain, infection and inflammation.

The agency said in a press announcement on its website that the unapproved ear drops contain the active ingredients benzocaine and hydrocortisone, neither of which has been evaluated by the FDA for safety, effectiveness or quality. The labels don’t inform the public that they lack FDA approval, and health care professionals may also be unaware of this information.

In a federal register notice published July 1, the FDA said it informed the companies that they must stop manufacturing the unapproved ear drops or the agency would carry out enforcement actions against the firms through seizure, injunction and/or criminal proceedings. FDA-approved prescription ear drops or legally marketed otic products are not affected by today’s action.

The unapproved ear drops contain the following ingredients:

-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.”

Patients taking unapproved drugs are at greater risk for other health problems because the products’ ingredients lack proven safety and effectiveness information. Unapproved products may be contaminated or manufactured incorrectly, which could result in patients taking the wrong dose, even when taken according to the instructions on the drug’s label.

Companies that wish to continue marketing these unapproved otic products must first gain the FDA’s approval. The firms may submit a new drug application (NDA) or an abbreviated new drug application (ANDA) for the FDA to consider.

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