Drug Discontinuation Communication: Benzocaine and Antipyrine (Auralgan) Otic Drops

Situation

Auralgan (benzocaine and antipyrine) otic drops are no longer manufactured. 

Background

The 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. 

Assessment

Auralgan (benzocaine and antipyrine) is the most commonly prescribed otic drop within SHF affected by this decision. Currently, Seton pharmacies have diminished all inventory of Auralgan. Auralgan and similar products are no longer manufactured and wholesalers no longer stock these products.    

Recommendations

Unfortunately, there are no specific alternative products to recommend at this time. Prescribers may consider systemic pain relief with acetaminophen, ibuprofen, and/or warm compress to the ear(s). 

Effective:  Immediately (Emailed to Seton Med-Staff Oct 26, 2015)

 

References:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm