OTCs Today
Mary Warner
Cerumen, or earwax, consists of a mixture of sebum, an oily secretion from the exocrine glands, and a milky, fatty fluid from the apocrine glands. It’s a naturally occurring substance that cleans, protects, and lubricates the ear canal. But when too much cerumen is present or becomes impacted, it can cause pain and itching.
Cerumen contains various antimicrobial substances (lysozymes) and has an acidic pH, which helps inhibit bacterial and fungal growth, and is important in the dark, moist, ear canal. Normally, cerumen is eliminated or expelled by natural migration out of the ear canal assisted by jaw movement, but narrow or irregularly shaped ear canals, the presence of excessive hair, irritation from hearing aids or ear plugs, the use of cotton-tipped swabs, atrophy of the ceruminous glands with aging, or a genetic tendency, can result in excessive cerumen in the ear canal. The presence of a foreign object in the ear seems to stimulate more wax production by the cerumen glands, but more research is needed to determine if hearing aid use increases the likelihood of an obstruction of the ear canal.
Patients with blocked ear canals often complain of ear fullness, dull pain, or itching, but may also experience tinnitus, dizziness, vertigo, cough, hearing loss, and hearing aid malfunction or feedback.
Cerumen-softening agents
The only FDA-approved nonprescription earwax-softening agent is carbamide peroxide 6.5% in anhydrous glycerin. It can be used alone or in conjunction with warm water irrigation to remove the loosened cerumen by adults and children 12 years or older. As carbamide peroxide is exposed to moisture, hydrogen peroxide and oxygen are released, resulting in a weak antibacterial effect and mechanical loosening of cerumen. The anhydrous glycerin solvent acts to soften and penetrate cerumen to help loosen excessive earwax.
For correct administration, 5 to 10 drops of the solution are placed in the affected ear(s) without the applicator tip entering the ear canal. The solution should remain in the ear canal for several minutes to allow effective softening of excessive earwax, followed by rinsing with warm water using an otic bulb syringe. Carbamide peroxide may be administered twice daily for up to 4 days.
Other options to reduce the buildup of cerumen in the ear canal include hydrogen peroxide and docusate, neither of which are FDA-approved to treat excessive/impacted cerumen.
Nonpharmacologic therapy
Earwax should only be removed by the patient when it has migrated to the outermost portion of the ear canal. Reusable ear-cleaning tools, or curettes, are available for manual earwax removal by adults.
Ear candling, a homeopathic remedy to remove excessive cerumen, is not recommended for any patient. Instructions for these products indicate that a hollow ear candle is inserted into the ear canal and the candle’s external protrusion is then lit on fire. While the hypothesis is that the flame of the burning candle creates negative pressure sufficient to draw cerumen from the ear canal and into the hollow area of the candle, this procedure can be dangerous, resulting in ear canal obstruction, hearing loss, tympanic membrane perforation, otitis externa, and burns to the patient’s hair, face, or ear.
FDA has posted consumer alerts and video warnings advising against the use of all candling products. In addition, FDA’s Center for Device and Radiological Health has indicated that product labeling for ear candling products is “false and misleading,” with no scientific evidence to support the practice.
What to tell your patients
Ensure that patients understand that inappropriate methods of removal of excessive or impacted cerumen, including use of cotton swabs, can push wax deeper into the ear and damage the ear canal or tympanic membrane, potentially resulting in a middle ear infection. Caution patients that self-removal of ear wax can result in damage to the ear canal. If patients experience pain or bleeding after repeated attempts to remove ear wax or if symptoms persist, a medical referral is necessary. Finally, ensure that patients are aware of the significant danger in ear candling and strongly advise against such means to remove excess cerumen.
For further information, see Chapter 30 of APhA’s Handbook of Nonprescription Drugs, available through the APhA bookstore at www.pharmacist.com or in PharmacyLibrary (www.pharmacylibrary.com). ■