In a recently published Federal Register notice, FDA threatened action against companies that manufacture or distribute certain unapproved eardrop products labeled for prescription use.
In a recently published Federal Registernotice, FDA threatened action against companies that manufacture or distribute certain unapproved eardrop products labeled for prescription use.
The products, known as otic products, are sold as relief for ear pain, infection, and inflammation. FDA said these products are often given to young children suffering from ear infections and other conditions that cause ear pain and swelling.
However, FDA said the unapproved and misbranded eardrops contain active ingredients such as benzocaine and hydrocortisone, and that the agency has not evaluated the products for safety, effectiveness, or quality.
Additionally, the labels on these products do not disclose that they have not received FDA approval.
FDA said companies manufacturing or distributing these otic products will be subject to product seizure, injunction and/or criminal proceedings.
Specifically, the unapproved otic drug products targeted contain benzocaine; benzocaine and antipyrine; benzocaine, antipyrine, and zinc acetate; benzocaine, chloroxylenol, and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine, and hydrocortisone.
“FDA has received at least five adverse event reports of allergic reactions to these drug products, including angioedema of the ear, eye, face, neck and/or mouth,” according to the Federal Register notice. “We are also aware of at least one case of methemoglobinemia associated with the administration of an otic product containing benzocaine in an infant, which resulted in death.”