FDA targets manufacturers of unapproved prescription ear drops

The FDA has issued a federal register notice targeting manufacturers and distributors of unapproved prescription otic drug products, which are frequently given to children for the relief of ear infections, according to a press release.

The manufacturers of these unapproved products could face product confiscation, injunctions and criminal proceedings if they do not cease manufacturing immediately, according to the release.

The targeted ear drop products, labeled to alleviate ear pain, infection and inflammation, contain active ingredients which have not been assessed by the FDA. Health care providers may be unaware that these products are not approved, since the labels do not disclose their FDA status.

Unapproved products may be contaminated or manufactured incorrectly, putting patients at risk. These products are often administered to children with ear infections, ear pain and swelling.

The notice covers products that include the active ingredients benzocaine, antipyrine, zinc acetate, chloroxylenol, hydrocortisone, and pramoxine.

The FDA noted that companies cited in their notice can submit either a new drug application or an abbreviated new drug application if they would like the FDA to consider them for approval.

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