II. Background
- In U.S., FDA forced manufacturers to stop producing Auralgan, Aurodex, A/B Otic...
- Original formulation used benzocaine, antipyrine (phenazone, an nsaid) and Glycerine (for drying) and had a long safety record
- Manufacturer changed the formulation (substituted polycosanol for Glycerin) and added acetic acid without FDA approval
- FDA cited that these agents were unapproved and without evidence of benefit or safety
- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm
- https://www.entandallergyspecialists.com/ent-and-allergy/fda-rightly-pulls-auralgan-off-market-forcefully/
III. Indications
IV. Adverse Effects: Benzocaine related (in Aurodex, Auralgan)
V. Precautions
- Risk of Methemoglobinemia
- Not recommended in age under 2 years
- Given lack of topical alternatives, age limit Handicaps the Acute Otitis Media Observation protocol
- Avoid overuse and stop if topical reaction
- Benzocaine (in Aurodex) is a common cause of Contact Dermatitis
- Avoid "new" Auralgan containing U-polycosanol 410 (uproven benefit)
- Costs $150 instead of old generic version price of $2
- Write to allow pharmacist to substitute with Generic Drug (either Aurodex or Benzocaine with Antipyrine)
VI. Dosing
- Use 2-4 drops three to four times daily
VII. Reference
- (2014) Presc lett 21(6): 36
- (2008) Presc Lett 15(5): 26