When your child next has ear pain the FDA wants to ensure they get only FDA approved prescription drugs that are effective and safe for your child.
The FDA is telling companies to cease marketing sixteen unapproved prescription drugs which have labels indicating they relieve swelling and ear pain. These drops contain active ingredients like hydrocortisone and benzocaine, but the FDA has not evaluated them for safety, quality, and effectiveness.
Pharmacies as well as health care providers have sold drugs that had labels which didn’t disclose that the product wasn’t approved by the FDA. Charles E. Lee, M.D of the FDA says that we don’t know if the drugs have any benefits and we can’t accept the chances that they may have risks.
Why FDA Is Taking Action at this Time
The FDA has its Unapproved Drugs Initiative, so it’s taking action. The FDA seeks to protect consumers from drugs that aren’t proven to be safe, of high quality, or effective.
It’s a risk to public health when a drug isn’t shown to be effective, especially if it has some safety concerns. The FDA has received reports that state the products can cause mouth, face, neck, eye, and ear local allergic reactions. Other symptoms can include burning, stinging, itching and irritation of the ear.
Unapproved ear drug products which require a prescription containing these ingredients are covered by the action of the FDA:
- benzocaine and antipyrine
- benzocaine, antipyrine and zinc acetate
- benzocaine, chloroxylenol and hydrocortisone
- chloroxylenol, pramoxine and hydrocortisone
- chloroxylenol and pramoxine
The quality of the drugs isn’t known for certain. When a drug is approved by the FDA, the drug manufacturing process is reviewed which ensure that the drug is of purity ad well as consistent quality. These unapproved ear drops have not been examines in this way. The products are prescribed for infants and small children so this is troubling. Drugs that are intended to be used on children should be tested in children. The drugs mentioned haven’t bene shown to be effective in anyone so there’s no proof that the products actually work.
Alternatives Approved by the FDA Available
There are other treatment options available for children with ear problems. The FDAs action only impacts a small percentage of drugs prescribed to treat otitis externa (outer ear infections), excess buildup of earwax, and otitis media (middle ear infections). There’s also F many OTC products available that can be used for earwax buildup or swimmers ear.
There are other solutions for ear problems and choices for consumer sot make. You need to use the products that are known to be safe and avoid the ones that haven’t been test fully for safety and effectiveness.