FDA Warns about Prescription Eardrops with Unapproved Ingredients and Announces Enforcement Action

Prescription eardrops that contain unapproved ingredients can be dangerous to children and the Food and Drug Administration (FDA) has announced enforcement against the companies that manufacture and sell these products.

The unapproved prescription otic (ear) products, which contain active ingredients such as benzocaine and hydrocortisone, are frequently given to young children who have ear infections or other conditions that cause ear pain and swelling. But these medications can be dangerous to the children they are supposed to help because they have not been evaluated for safety or effectives, an FDA news release explains.

The products may be contaminated or may have been manufactured incorrectly, which could result in the child receiving the wrong dose, even when the drops are administered according to the label directions, the FDA says. The unapproved prescription eardrops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality, an FDA news release reports. 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.

In July, the FDA published a notice in the federal register to inform companies that make the unapproved eardrops that they must stop manufacturing unapproved prescription products or be subject to enforcement actions that could include “seizure, injunctions and/or criminal proceedings.” The agency says the action does not affect FDA-approved prescription otic products, or legally marketed over-the-counter products.

The products that have been targeted in the FDA action are those that contain the following ingredients and combinations:

• benzocaine
• benzocaine and antipyrine
• benzocaine, antipyrine, and zinc acetate
• benzocaine, chloroxylenol, and hydrocortisone
• chloroxylenol and pramoxine
• chloroxylenol, pramoxine, and hydrocortisone.

Benzocaine is a local anesthetic that helps relieve pain. It is an approved ingredient in a number of medicines but it has not been evaluated or approved for use in eardrops. CBSNewYork reports that benzocaine eardrops were fatal for a baby who was given the drops despite warnings not to use them in infants younger than one year of age. Pediatric otolaryngologist Dr. Jack C. Borders Jr. said these medicines can produce “serious complications.” The FDA action targets 16 different prescription drops for ear pain and swelling that were never approved by the FDA.

Dr. Borders said these medicines have been widely used and many doctors feel these medicines have been effective for their patients. But, Borders explains, “we don’t really have hard and fast data to prove that.”

The FDA recommends that parents who have drops that contain ingredients on the list should ask their child’s doctor for a different prescription. Guidelines from the Academy of Pediatrics recommend treating ear pain with over-the-counter pain medicine. Antibiotics should not be prescribed unless the child has a high fever or there is a fluid buildup and discharge in the middle ear, CBSNewYork reports.

 

 

 

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