Companies who are marketing unapproved product to treat ear wax, as well as eye drops, face action from the U.S. Food and Drug Administration (FDA). Pharmtech reports the FDA is concerned about products marked to relieve ear pain, infection, and inflammation. This is because the problematic products have not been properly tested so that such claims can be verified. The labels affixed to such products do not warn nurses, clinicians and consumers that the products have not been FDA approved.
Another cause of concern is that the products contain active ingredients that have not been evaluated in a controlled manner. Such ‘actives’ include benzocaine and hydrocortisone. Other ingredients of concern are chloroxylenol and pramoxine. The suspicious products may contain one of these ingredients or two in combination. The combinations in question, and the ones for consumers to be wary of, are:
benzocaine;
benzocaine and antipyrine;
benzocaine, antipyrine, and zinc acetate;
benzocaine, chloroxylenol, and hydrocortisone;
chloroxylenol and pramoxine; and
chloroxylenol, pramoxine, and hydrocortisone.
Benzocaine is a local anesthetic. It is more commonly used in cough drops. Hydrocortisone is a medicine which is used in dermatitis and eczema. Neither are necessarily well-suited for ear drops.
According to FDA products containing these ingredients have these products have “caused local allergic reactions of the ear, eye, face, neck and mouth.” Furthermore, they have also triggered “itching, stinging, burning and irritation of the ear.”
The types of actions that the federal agency could take include seizure of good, injunctions to stop a company from trading and even criminal proceedings. This forms part of the FDA’s Unapproved Drugs Initiative. This campaign focuses on drugs with potential safety risks and drugs that lack evidence of effectiveness.
