FDA Targeting Companies that Market Unapproved Prescription Ear Drops

FDA Targeting Companies that Market Unapproved Prescription Ear Drops
July 1, 2015

Your doctor and pharmacist might be prescribing ear drops that haven't been approved by the Food and Drug Administration (FDA).

The agency is notifying companies to stop marketing 16 unapproved prescription drugs labeled to relieve ear pain and swelling because they have not been evaluated by the FDA for safety, effectiveness, and quality.

The FDA is only targeting specific medications prescribed to treat pain and swelling that result from otitis media (middle ear infections), otitis externa (outer ear infections), and excess buildup of earwax.

The FDA says that for years health care providers have prescribed – and pharmacies – have sold ear infection medication whose labels did not disclose that they weren't approved by the FDA.

While vitamins and supplements are not subject to FDA scrutiny, prescription medication is to ensure it has been proved safe, effective and of high quality. The FDA has received reports that some of these unapproved products caused local allergic reactions, itching, stinging, burning and ear irritation.

Most often these products are prescribed for young children and infants, who are most susceptible to ear infections.

"It's very basic—drugs that are used in children should be tested in children," the FDA's Charles E. Lee said in a statement. "These products haven't been shown to be effective in anyone, and there's no proof that they work."

Consumers who are using ear drops and question their validity should discuss alternatives with their doctors. Any side effects from these products should be reported to the FDA.