Unapproved ear drop products will be taken down by FDA

U.S. Food and Drug Administration announced unapproved ear drop products will be handled closely and actions will be taken against those who manufacture and/or market them.

Certain Unapproved ear drop products, professionally known as otic products, have been marketed as OTC (Over The Counter) widely in the USA. These ear drop products claim to ear relieve pain, ear infections and inflammation. These products contain active ingredients, and have not been evaluated by FDA for safety, effectiveness or quality.

Among other ingredients, the main ingredients which FDA monitors and evaluate are the active ingredients, affecting the body. These ingredients include:

• benzocaine;
• benzocaine and antipyrine;
• benzocaine, antipyrine, and zinc acetate;
• benzocaine, chloroxylenol, and hydrocortisone;
• chloroxylenol and pramoxine; and
• chloroxylenol, pramoxine, and hydrocortisone.

The new enforcement and actions do not affect FDA-Approved prescription products, and it does not affect legally marketed OTC products. As part of the new enforcement, the FDA plans to seize, issue of injunction and criminal proceedings.

The FDA’s aim with these new actions is to “protect patients from unnecessary risks”, said FDA’s Cynthia Schnedar. “There are many FDA approved prescription products to treat ear infections, so we expect little to no impact on patients from the removal of these unapproved and potentially unsafe products”, she added.

Unapproved prescription otic products are given frequently to toddlers and young children, suffering from ear infections and other conditions that cause ear pain and swelling. The unapproved products endanger the users, since there is no information on their safety or their effectiveness. Due to lack of supervision and evaluation, even when used according to labeled directions of use, patients are expose to various risks. The full announcement can be found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm

From a patient’s point of view, it is important to check each and every product or treatment one might use. It is important to know as much as possible on the treatment - how it works, what side effects it may have, and if there are active ingredients - what is their effect. it is even more important when used simultaneously with other drugs. If you are not familiar with a drug or Over The Counter product you are about to use, please consult your doctor before you do so.