The Food and Drug Administration in the USA is calling on parents to ensure that the next time your child has ear pain requiring a prescription drug, make sure the product has been approved by FDA or regulatory body and has been declared as safe and effective.
The FDA has begun notifying companies to stop marketing 16 unapproved prescription drugs labeled to relieve ear pain and swelling. These ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by FDA for safety, effectiveness and quality.
For years, health care providers have prescribed—and pharmacies have sold—these drug products whose labels did not disclose that they weren’t approved by FDA.
“If we don’t know whether these drugs have any benefits, we should not accept any possible risk of side effects,” says FDA’s Charles E. Lee, M.D.
Using a product that has not been shown to be effective, especially when we have evidence of some safety concerns, is risky to the public health. FDA has received a few reports that these products had caused local allergic reactions of the ear, eye, face, neck and mouth. They can also cause itching, stinging, burning and irritation of the ear.
Unapproved prescription ear drug products containing these ingredients are covered by FDA’s action:
• benzocaine and antipyrine
• benzocaine, antipyrine and zinc acetate
• benzocaine, chloroxylenol and hydrocortisone
• chloroxylenol and pramoxine
• chloroxylenol, pramoxine and hydrocortisone
The quality of these drugs is uncertain. When FDA approves a drug, we review the manufacturing processes to ensure that the drugs are of consistent quality and purity, Lee says. That’s not the case with these unapproved ear drops.