The U.S. Food and Drug Administration has announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.
The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. 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.
In a federal register notice published today, the agency informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today's action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.
Unapproved prescription otic drug products containing the following ingredients are covered by this action:
- benzocaine and antipyrine;
- benzocaine, antipyrine, and zinc acetate;
- benzocaine, chloroxylenol, and hydrocortisone;
- chloroxylenol and pramoxine; and
- 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."
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.
Companies making and selling unapproved otic drug products covered by this action that are not currently listed with the FDA must stop manufacturing and shipping the products immediately. Companies that wish to market the drug products covered by this action can submit a new drug application (NDA) or an abbreviated new drug application (ANDA) for the FDA to consider approval of these products.
Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives. Today's action is part of the FDA's Unapproved Drugs Initiative, which seeks to reduce consumer exposure to drugs that are not proven to be safe, effective and of high quality.
Consumers and health care professionals are encouraged to report adverse events or medication errors from the use of unapproved prescription products to the FDA's MedWatch Adverse Event Reporting Program.