why was auralgan discontinued

by Ernesto Turner IV Published 3 years ago Updated 3 years ago

Why was auralgan discontinued? On July, 2, 2015 the FDA asked all manufacturers of antipyrine and benzocaine otic products (Auralgan and Aurodex brand names) to stop selling these products because they have not been proven to be safe and effective. Click to see full answer. Correspondingly, is auralgan off the market?

On July, 2, 2015 the FDA asked all manufacturers of antipyrine and benzocaine otic products (Auralgan and Aurodex brand names) to stop selling these products because they have not been proven to be safe and effective.

Full Answer

Why was Auralgan taken off the market?

FDA rightly pulls Auralgan off market…forcefully. The FDA had US marshalls confiscate all supplies of Auralgan for illegally marketing it even after warnings, which the maker ignored. Auralgan is a well-known, old fashioned ear medicine used for decades by ENT doctors to ease pain in patients with ear infections.

Are there any alternative products for Auralgan?

Auralgan and similar products are no longer manufactured and wholesalers no longer stock these products. 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).

What happened to Auralgan in SHF?

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.

Are benzocaine and antipyrine (Auralgan) otic drops still available?

Drug Discontinuation Communication: Benzocaine and Antipyrine (Auralgan) Otic Drops Auralgan (benzocaine and antipyrine) otic drops are no longer manufactured.

Is auralgan off the market?

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

Is auralgan over the counter?

Auralgan is a prescription medicine used to treat the symptoms of inflammation of the middle ear (Acute Otitis Media) and to remove earwax (cerumen). Auralgan may be used alone or with other medications.

Is auralgan ear drops safe?

Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: burning/stinging/redness/new pain in or around the ears. This medication has rarely caused a very serious (possibly fatal) blood disorder (methemoglobinemia).

How long can you use auralgan?

Eardrops should be used within 1 or 2 months of opening, although the time period may vary from one product to another. Ask your pharmacist how long you can keep this medication. Generally, this medication is used only as needed.

What ear drops help with ear infection?

Ciprofloxacin and dexamethasone combination ear drops is used to treat ear infections, such as acute otitis externa and acute otitis media.

Can you use auralgan for swimmers ear?

Auralgan helps to remove wax in the ear canal, as well as provide pain relief for swimmer's ear. It can also be used as an add-on product when you have otitis media.

Can lidocaine be used in the ear?

Anesthesia of the ear canal is produced by injection of lidocaine hydrochloride into the skin of the lateral external ear canal. Ear canal, tympanic membrane, and middle ear surgeries are performed with this injection.

Do they make numbing ear drops?

Anesthetic (Numbing) Ear Drops Anesthetic ear drops can help alleviate pain and swelling caused by ear infections. They aren't often recommended, though, because they do not treat the infection, and other pain relievers can be used such as acetaminophen or ibuprofen.

Can kids use auralgan ear drops?

Conclusion: In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes.

How fast does auralgan work?

Other Medical Therapies for Acute Otitis Media Topical benzocaine (Auralgan Otic, Americaine Otic) provides additional but brief (30 to 60 minutes) improvement in pain control compared with acetaminophen or ibuprofen and appears to be more effective in children older than 5 years.

What is auralgan used for?

Auralgan is a well-known, old fashioned ear medicine used for decades by ENT doctors to ease pain in patients with ear infections. Its been around so long that it has a well established record of efficacy and safety as well as a generic form that is very inexpensive.

How does acetic acid help ear infections?

Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow.

What is antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

Antipyrine/benzocaine is a combination product used for cleaning the ear canal and for treating middle ear infections. It reduces pressure, congestion, inflammation, pain, and discomfort in the ear.

What is the dosage for antipyrine and benzocaine otic (Auralgan, Aurodex - discontinued)?

To clean earwax, 3 to 4 drops of antipyrine and benzocaine octic solution is placed into the ear canal three times a day for 2 to 3 days.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

ohiovolffemtp

Auralgan got pulled by the FDA after making excessive claims. The old generic AB Otic was still available for awhile, but now it's gone too. Does anyone have any alternatives for topical analgesia for ear complaints? Thanks

ERCat

I just spoke to a pharmacist about this after one of my Rx bounced back. He said there isn't any alternative at the moment! Bummer... Hopefully others have some good ideas?

ljkdhall

Not sure if anyone is still following this topic, but instill a drop or two of viscous lidocaine into the ear canal, ordered pretty much the same way you would order the Auralgan

ohiovolffemtp

I use proparicaine in the ED, do you send pt's home with a Rx for the viscious lido?

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15. /app/View/Composers/SidebarView.php:12
16. /vendor/laravel/framework/src/Illuminate/View/Concerns/ManagesEvents.php:124
17. /vendor/laravel/framework/src/Illuminate/View/Concerns/ManagesEvents.php:162
20. /vendor/laravel/framework/src/Illuminate/View/Concerns/ManagesEvents.php:177

Metadata
Bindings	0. 15663
Backtrace	21. view::2dd102cf0462e89a4d4d8bc77355d767652bf9aa:15 23. /vendor/laravel/framework/src/Illuminate/Filesystem/Filesystem.php:108 24. /vendor/laravel/framework/src/Illuminate/View/Engines/PhpEngine.php:58 25. /vendor/livewire/livewire/src/ComponentConcerns/RendersLivewireComponents.php:69 26. /vendor/laravel/framework/src/Illuminate/View/Engines/CompilerEngine.php:61

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Backtrace

21. view::2dd102cf0462e89a4d4d8bc77355d767652bf9aa:15
23. /vendor/laravel/framework/src/Illuminate/Filesystem/Filesystem.php:108
24. /vendor/laravel/framework/src/Illuminate/View/Engines/PhpEngine.php:58
25. /vendor/livewire/livewire/src/ComponentConcerns/RendersLivewireComponents.php:69
26. /vendor/laravel/framework/src/Illuminate/View/Engines/CompilerEngine.php:61

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