FDA Takes Action Against Makers of Unapproved Rx Ear Drops

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA is mandating that drug companies stop manufacturing unapproved otic drops that are labeled for prescription use to relieve ear pain, infection, and inflammation. These products are frequently given to young children, the agency notes, and healthcare providers may not know that they are unapproved.

The products in question contain any of the following active ingredients:

• Benzocaine

• Benzocaine and antipyrine

• Benzocaine, antipyrine, and zinc acetate

• Benzocaine, chloroxylenol, and hydrocortisone

• Chloroxylenol and pramoxine

• Chloroxylenol, pramoxine, and hydrocortisone

The FDA has received at least five reports of allergic reactions to these products, including angioedema of the ear, eye, face, neck, or mouth. In addition, a fatal case of methemoglobinemia was reported in an infant who received otic drops containing benzocaine.

Clinicians are encouraged to report adverse events related to these products to the FDA's MedWatch program (see link below).

Cornelius W. Van Niel, MD, associate editor of NEJM Journal Watch Pediatrics and Adolescent Medicine, says: "I — and I'm sure many other pediatricians — rely on these products often. In my experience, they help limit the unnecessary use of antibiotics for many children with uncomplicated middle ear infections. Anecdotally, my patients have never had any problems with them."