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 and antipyrine
- benzocaine, antipyrine, and zinc acetate
- benzocaine, chloroxylenol, and hydrocortisone
- chloroxylenol and pramoxine
- chloroxylenol, pramoxine, and hydrocortisone
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.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Antipyrine and benzocaine otic is used to relieve ear pain and swelling caused by middle ear infections. It may be used along with antibiotics to treat an ear infection. It is also used to help remove a build up of ear wax in the ear. Antipyrine and benzocaine are in a class of medications called analgesics. The combination of antipyrine and benzocaine works by reducing pain and discomfort in the ear.
How should this medicine be used?
Antipyrine and benzocaine otic comes as a solution (liquid) to place into the ear. When antipyrine and benzocaine is used to relieve ear pain, it is usually used every 1 to 2 hours as needed. When antipyrine and benzocaine is used to help in the removal of ear wax, it is usually used 3 times daily for 2-3 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use antipyrine and benzocaine otic exactly as directed.
Antipyrine and benzocaine otic is for use only in the ears.
To use the eardrops, follow these steps:
- Hold the bottle in your hand for 1 or 2 minutes to warm the solution.
- Place the prescribed number of drops into your ear.
- Be careful not to touch the tip to your ear, fingers, or any other surface.
- Moisten a small piece of cotton with the drops and insert into the outer ear.
- Repeat steps 2-4 for the opposite ear if necessary.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using antipyrine and benzocaine otic,
- tell your doctor and pharmacist if you are allergic to antipyrine or benzocaine or any other medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you have a hole in your ear drum(s) or ear tube(s). Your doctor will probably tell you not to use this medication.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using antipyrine and benzocaine otic, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
This medication is usually used as needed. If your doctor has told you to use antipyrine and benzocaine otic regularly, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use extra solution to make up for a missed one.
What side effects can this medication cause?
Antipyrine and benzocaine otic may cause side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. Antipyrine and benzocaine otic should be disposed of 6 months after the bottle is opened.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
If someone swallows antipyrine and benzocaine otic, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
§ These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs (http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).