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Safety Alerts for Human Medical Products > Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
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Unapproved Prescription Ear Drop (Otic)
Products: Not FDA Evaluated for Safety,
Effectiveness and Quality
[Posted 07/01/2015]
AUDIENCE: Family Practice, Consumer, Pediatrics
ISSUE:
FDA announced its intention to take enforcement action against companies
that manufacture and/or distribute certain unapproved prescription ear drop products
(known as otic products) labeled to relieve ear pain, infection, and inflammation. The
unapproved prescription ear drops contain active ingredients such as benzocaine
and
hydrocortisone, and have not been evaluated by the FDA for safety,
effectiveness and quality. The labels on these products do not disclose that they lack
FDA approval, and health care professionals may not be aware of their unapproved
status.
Unapproved prescription otic drug products are frequently given to young children
suffering from ear infections and other conditions that cause ear pain and swelling.
Patients taking unapproved drugs may be at greater risk because there is
no proven
safety or effectiveness information. These products may be contaminated or
manufactured incorrectly, which could result in patients
receiving the wrong dose,
even when administered according to the labeled directions for use.
Unapproved prescription otic drug products containing the following ingredients are
covered by this action:
benzocaine;
benzocaine and antipyrine;
benzocaine, antipyrine, and zinc acetate;
benzocaine, chloroxylenol, and hydrocortisone;
chloroxylenol and pramoxine; and
chloroxylenol, pramoxine, and hydrocortisone.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm[7/2/2015 4:13:20 PM]
Safety Alerts for Human Medical Products > Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
BACKGROUND:
FDA informed the companies that they must stop manufacturing
these unapproved prescription otic products or be subject to enforcement actions,
including seizure, injunction and/or criminal proceedings. Today’s action does not
affect FDA-approved prescription otic products, or legally marketed otic products sold
over-the-counter.
RECOMMENDATION:
Consumers who believe they are using unapproved
prescription ear drops should contact their health care provider to discuss
alternatives.
Healthcare
professionals and patients are encouraged to report adverse events or
side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form
or call 1-800-332-1088 to request a reporting form, then complete
and return to the address on the pre-addressed form, or submit by fax to 1-800FDA-0178
[07/01/2015 - News Release - FDA]
[07/01/2015 - Consumer Update - FDA]
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Page Last Updated: 07/01/2015
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm[7/2/2015 4:13:20 PM]
Safety Alerts for Human Medical Products > Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm[7/2/2015 4:13:20 PM]