Trusted & Validity:All our courses are developed by a team of authorized U.S. board certified and licensed medical doctors.

Our nationally recognized certificates are signed by authorized board certified U.S. medical doctors.

Nationally Accepted Certification
American Academy of CPR & First Aid, Inc.®

Online CPR Certification Blog

FDA Targets Unapproved Otic Drops

Aug
08

Date: August 8th, 2015

A lot of the ear drops that doctors have been prescribing for years have never been approved by the Food and Drug Administration as treatments for ear pain. The true benefits of these drugs have not been researched, and the possible side effects of using them have not been determined.

How do I know if I am using a Suspect Ear Drop on my Children?

The ear drops in question do not have the Food and Drug Administration stamp of approval on their packaging. The drops that the Food and Drug Administration are concerned about represent a very small fraction of the drugs that are prescribed to alleviate pain of middle ear infections, outer ear infections, and conditions of waxy build up in the ear canal.

There are many different medications sold over the counter and by prescription that have been evaluated and approved by the Food and Drug Administration. If a drug has FDA approval, the drug manufacturers will prominently display this fact on their packaging.

Possible drug side effects

There have been reports of patients using these drops experiencing itching in the ear canal, burning sensations, stinging, redness of the ear or ear canal, and irritation to the inner ear, and any skin the drop has come into contact with.

Ingredients found in the suspect ear drops

The eardrops that are under question may contain one or more of the following ingredients.

  • Benzocaine
  • Zinc acetate
  • Antipyrine
  • Chloroxylenol
  • Pramoxine
  • Hydrocortisone

What this means to parents

Basically a parent should simply make sure that the medication they are using to treat their children’s symptoms has the Food and Drug Administration approval for use in children, and for the condition the child has.

Ask your doctor or pharmacist if the medication they are giving you has FDA approval for use in that manner. You are the spokes-person for your child, and if the medicine is not FDA approved, then you should consider asking for a different medication, or asking the doctor if they are certain that the medicine is safe.

Watch for any signs of adverse reactions from your child when they begin using a medication. Even if they are using a medication that has been approved by the food and drug administration. At the first sign of a reaction to a medication discontinue the usage until you can see a doctor.

What this means for health care professionals

As health care professionals, you have to be diligent in making sure you know what drug companies have not yet received the approval from the food and drug administration. There is a great deal of pressure from drug companies for doctors to write prescriptions for their products, but you will need to be certain that the drugs you prescribe are FDA approved, and safe for the usage by children. Note that even for the adults, it is still very dangerous and unethical to administer drugs that are not FDA-approved. They could cause serious effects that could warrant the application of adult CPR.

What this means for the medications in question

The medications that are under scrutiny will have to be tested and proven to be effective for the treatment purpose they are prescribed for.

Leave a Reply


− 2 = 6

Security verified Seal Certified Seal Privacy Seal Business Verified Seal