Ear Drops - Warning

[GF Lover]

Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality

 

AUDIENCE: Family Practice, Consumer, Pediatrics

 

ISSUE: FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. 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.

Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.

Unapproved prescription otic 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.

 

BACKGROUND: FDA informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

RECOMMENDATION: Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

Complete and submit the report Online: www.fda.gov/MedWatch/report

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA news release, at:

 

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[anastunya]

These otic products do not contain gluten. The FDA wants to control everything that touches our body. This will just make products more expensive, not safer, as the FDA is in league with Big Pharma. Ear pain drops have helped millions of children over the decades.

[kareng]

These otic products do not contain gluten. The FDA wants to control everything that touches our body. This will just make products more expensive, not safer, as the FDA is in league with Big Pharma. Ear pain drops have helped millions of children over the decades.

I don't think anyone said they contain gluten - but even if they did, they aren't ingested.

Knowing Colleen, I think she saw this notice and thought it might be helpful for some people.

Perhaps some over sight on products marketed as medication or supplements would keep people from wasting money on useless or dangerous cures?

Please note - this isn't a place to discuss conspiracy theories.

[LauraTX]

The problem when people use things that may not work is that something like an ear infection can go without proper treatment and lead to permanent life altering consequences for a child, like deafness.  It is important to share info like this.  Nothing to do with gluten or other conspiracy theories, the OP was just giving other parents a heads up.