In a July 1st press release, the U.S. Food and Drug Administration (FDA) announced that it plans “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.” According to the announcement, active ingredients such as benzocaine and hydrocortisone are used in the unapproved ear drops. The FDA has not evaluated these products for safety or efficacy, and the products do not indicate that they are not FDA-approved.
The FDA states that healthcare professionals may not know that these ear drop products lack FDA approval since it is not disclosed on the label. The agency stated in a federal register notice that companies will be “subject to enforcement actions, including seizure, injunction and/or criminal proceedings” if they do not stop manufacturing unapproved otic products. According to the announcement, unapproved otic products contain the following ingredients:
- benzocaine and antipyrine
- benzocaine, antipyrine, and zinc acetate
- benzocaine, chloroxylenol, and hydrocortisone
- chloroxylenol and pramoxine
- chloroxylenol, pramoxine, and hydrocortisone.
Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said “Taking enforcement actions against these unapproved products will protect patients from unnecessary risks,” according to the release. “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.”
Young children who suffer from ear infections and other conditions that cause ear pain and swelling are often given unapproved otic products. Unapproved drugs carry greater risks because the FDA has not received adequate evidence that the product is safe and effective. There may be issues with quality control, including contamination and other manufacturing violations, that can cause incorrect doses to be administered even when direction are followed closely.