10202017Headline:

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Unapproved Ear Drops Banned by the FDA

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The U.S. Food and Drug Administration (FDA) has announced that it will take action against companies that manufacture and/or distribute unapproved prescription ear drops with labels claiming to relieve ear pain, infection, and inflammation.

The unapproved drops have not been evaluated by the FDA and contain the following active ingredients:

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

Young Children at Greater Risk

Such unapproved prescription otic drug products are often prescribed to young children suffering from ear infections, swimmers ear, and other conditions that cause pain and swelling. These patients may be at greater safety risk because there is no proven information regarding effectiveness, or the products may be contaminated or made incorrectly, or their use can result in incorrect dosage, even when the directions on the label are carefully followed.

Unapproved Drugs May or May Not be Harmful

The FDA is not saying that the unapproved products are harmful, only that it has not evaluated the products safety because the drops have not been evaluated and approved. The companies making and marketing the drugs covered in this action are required by the FDA to stop manufacturing and shipping the products immediately, and if they wish to market the drugs in the future, they must submit a new drug application or an abbreviated new drug application to the FDA for consideration.

The FDA is taking this action for several reasons, including protecting consumers from drugs that are not proven safe, effective, and because of the risk of potential side effects. Consumers are encouraged to use one of the many FDA-approved drugs for middle and outer ear infections or over-the-counter products that have been proven to be effective for the prevention of swimmer’s ear and earwax buildup, and are urged to contact their health care provider to discuss alternatives that do not contain the unapproved ingredients.

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    […] Unapproved Ear Drops Banned by the FDA Such unapproved prescription otic drug products are often prescribed to young children suffering from ear infections, swimmers ear, and other conditions that cause pain and swelling. These patients may be at greater safety risk because there is no … Read more on Legal Examiner […]