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You might be using eardrops that haven't been tested for effectiveness and safety

by , 09 July 2015

This week, the US Food and Drug Administration (FDA) announced that there are 16 brands of eardrops out there that they haven't approved. Scary thing is all 16 are prescription drops…

The FDA says the unapproved drops remain unevaluated for pain relief, swelling, effectiveness and safety. So needless to say, it's important to make sure you're not using these eardrops!

Read on to find out more about this array of unapproved eardrops.

FDA says unapproved eardrops can be harmful

The FDA reported that the unapproved eardrops on the market can cause allergic reactions. Not only in your ears, but also your eyes, face, neck and mouth. They also reported that the drops might cause itching, stinging, burning and irritation of the ear.
“If we don’t know whether these drugs have any benefits, we shouldn’t accept any possible risk of side effect,” said Dr Charles Lee of the FDA in a news release.

So wait – what are the names of the unapproved eardrops?

Unfortunately, the FDA didn’t release the name of the companies or medications involved. But they did note that “unapproved prescription drug products containing the following ingredients are covered by this action: Benzocaine; benzocaine and antipyrine; benzocaine, antipyrine, and zinc acetate; benzocaine, chloroxylenol, and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine, and hydrocortisone.
The drugs’ packaging also won’t disclose that the drops aren’t FDA-approved, Dr Lee noted.
Dr Lee said what’s most worrisome is that some of these products are prescribed for young children and infants – those most likely to develop ear infections.

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“It’s very basic – drugs that are used in children should be tested in children,” Dr Lee said. “These products haven’t been shown to be effective in anyone, and there’s no proof that they work.”

What to do if you think your doctor’s prescribed you unapproved ear drugs

Dr Lee suggests asking him or her for alternatives. 
Also, if you or a family member is experiencing side effects from eardrops, contact your doctor immediately.

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