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FDA MedWatch <fda

Sat, Feb 20, 2010 at 6:29 PM

Ear Candles: Risk of Serious Injuries-Consumers warned not to use

ear candles because they can cause burns, perforation, blockage

al

 

 

[image: MedWatch logo] [image: MedWatch - The FDA Safety Information and

Adverse Event Reporting Program]

 

*Ear Candles: Risk of Serious Injuries*

 

*Audience*: Consumers, Otolaryngological healthcare professionals

 

FDA is notifying consumers and healthcare providers of its warning not to

use ear candles - a hollow cone about 10 inches long made from a fabric tube

soaked in beeswax, paraffin or a mixture of the two - because they can

cause *serious injuries*, even when used according to the manufacturer’s

directions. According to advertised claims, a burning ear candle draws ear

wax and “impurities” or “toxins” out of the ear canal. Other claims for ear

candles include relief from sinus and ear infections, headache and earache,

as well as improved hearing, “blood purification,” improvements in brain

function, and cure cancer. FDA has found no valid scientific evidence to

support the safety or effectiveness of these devices for any medical claims

or benefits. FDA has received reports of burns, perforated eardrums and

blockage of the ear canal which required outpatient surgery from the use of

ear candles.

 

FDA is especially concerned because some ear candles are being advertised

for use in children. Children of any age, including babies, are likely at

increased risk for injuries and complications if they are exposed to ear

candles. Small children and infants may move during the use of the device,

increasing the likelihood of wax burns and ear candle wax plugging up the

ear canal. Also, their smaller ear canal size may make children more

susceptible than adults to injuries.

 

Ear candles are sold and promoted in a variety of locations, including

health food stores, flea markets, health spas and salons, as well as on

commercial web sites.

 

Consumers and health care professionals are strongly encouraged to report

injury related to the use of ear candles to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

 

- Online:

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- Phone: 1-800-332-1088

- Mail: return the postage-paid FDA form 3500, which may be downloaded

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- Fax: 1-800-FDA-0178

 

Read the complete MedWatch 2010 Safety summary, including a link to the FDA

Advice for Patients, at:

 

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yYT0mJiY= & & & 102 & & & http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAle\

rtsforHumanMedicalProducts/ucm201108.htm>

 

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