Pharmacists Should Stay Alert for Unapproved Rx Ear Drops


Following the FDA's enforcement actions against unapproved otic products, pharmacies should be seeing fewer prescriptions for these medications.

Last summer, the FDA announced its intention to take action against manufacturers and distributors of unapproved prescription ear drops claiming to relieve ear pain, inflammation, and infection.

According to the FDA, these ear drops have not been evaluated for safety, effectiveness, and quality. Because the otic products’ labels do not indicate that they are not FDA-approved, many health care professionals may be unaware of risks related to use.

Many retail pharmacies stock ear drops labeled “A/B Otic,” but following the FDA’s seizure, injunction, and other enforcement actions against unapproved otic products, pharmacies should be seeing fewer prescriptions for these medications.

Unapproved prescription otic medications affected by these FDA actions include:

  • Benzocaine
  • Benzocaine and antipyrine
  • Benzocaine, antipyrine, and zinc acetate
  • Benzocaine, chloroxylenol, and hydrocortisone
  • Chloroxylenol and pramoxine
  • Chloroxylenol, pramoxine, and hydrocortisone

It is crucial for pharmacists, especially those in the retail setting, to intervene in order to ensure patient safety when they see prescriptions for these unapproved products. Many times, caregivers are overwhelmed by information provided by other health care professionals, so they arrive at the pharmacy feeling very confused and overwhelmed.

As pharmacists, it is our duty to promote patient safety and counsel patients and caregivers using the most up-to-date information. Clinical treatment guidelines from the American Academy of Otolaryngology—Head and Neck Surgery contain a list of recommended FDA-approved drops for treating diffuse acute otitis externa.

This list includes:

  • Acetic acid 2.0% solution
  • Acetic acid 2.0%, hydrocortisone 1.0%
  • Ciprofloxacin 0.2%, hydrocortisone 1.0%
  • Ciprofloxacin 0.3%, dexamethasone 0.1%
  • Neomycin, polymyxin B, and hydrocortisone
  • Ofloxacin 0.3%

These treatment guidelines also recommend that clinicians treat pain with oral analgesics based on pain severity. Although the guidelines do not specifically state which analgesics are preferred, it is reasonable to recommend acetaminophen and ibuprofen.

With these recent developments, pharmacists need to emphasize the use of oral analgesics to treat ear pain and inform patients and other heatlh care providers about unapproved otic drops. Because some clinicians may still be unaware of this recent update, pharmacists should use their clinical judgement and intervene before dispensing unapproved ear drops.


Rosenfel RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa executive summary. Otolaryngol Head Neck Surg. 2014 Feb;150(2):161-8. doi: 10.1177/0194599813517659.

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