The Food and Drug Administration (FDA) has announced enforcement action against companies that distribute certain unapproved prescription ear drop products labeled to relieve ear pain, infection, and inflammation.
The unapproved prescription ear drops-known as otic products-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, according to the agency’s news release.
The agency published a notice in the Federal Register on July 1, informing the companies that they must stop manufacturing unapproved prescription otic products or be subject to such actions as seizure, injunction, and/or criminal proceedings.
The action does not affect FDA-approved prescription otic products
The action does not affect FDA-approved prescription otic products, or legally marketed over-the-counter otic products. The July 1 action is part of the FDA’s Unapproved Drugs Initiative, which seeks to reduce exposure to drugs that are not proven to be safe, effective and of high quality.
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
- 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. Schnedar said the agency expects “little or no impact on patients” because there are many FDA-approved prescription products to treat ear infections.”
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
Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information for the products.
The products may be contaminated or may have been manufactured incorrectly, which could result in patients receiving the wrong dose, even when the medication is administered according to the label directions for use.
Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternative medications.
Companies making and selling otic drug products covered by this action 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 their products.
The FDA encourages consumers and health care professionals to report adverse events or medication errors from the use of unapproved prescription products to the FDA’s MedWatch Adverse Event Reporting Program.