FDA: Unapproved Substances In Eardrops Can Cause Serious Side Effects
NEW YORK (CBSNewYork) -- Earaches can be painful for any child, and parents may worry about what medicine is best to give their kids.
Now, a warning from the Food and Drug Administration has some pediatricians and pharmacists giving out unapproved medicine.
Steve Wolf still remembers how his son, Dashton, used to howl from the pain of his chronic ear infections.
"They'd keep him up at night. He'd be crying through the night," Wolf said. "We'd be calling the emergency room; calling his doctor."
Wolf said the doctor gave him medication, including prescription eardrops, that silenced the suffering.
"We found a combination of remedies worked best, combining antibiotics to fight the underlying infection; painkillers such as benzocaine to treat the pain," Wolf said.
But benzocaine is now the target of an FDA warning. The agency warned that ear drops with the substance can lead to dangerous side effects.
In one case, benzocaine ear drops were even fatal, when a baby was given the drops despite warnings not to use them in infants younger than one year of age.
Benzocaine, a local anesthetic, is one of six drugs that are allowed by regulators for certain medicines. The others include benzocaine and antipyrine; benzocaine, antipyrine and zinc acetate; benzocaine, antipyrine and hydrocortisone; benzocaine, chloroxylenol and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine and hydrocortisone.
But those drugs were never evaluated by the FDA for use in ear drops.
"Over the years, those medicines have been used a lot. And the FDA is simply pulling the medical community back in to say, 'Wait a minute,'" said pediatric otolaryngologist Dr. Jack C. Borders Jr. "There can be serious complications to these medicines."
The FDA is clamping down on companies that make and sell 16 different prescription drops for ear pain and swelling, but were never approved by the FDA.
"There are a lot of pediatricians, a lot of doctors in this country, that will say the medicines on that list have been effective for their patients," Borders said. "The trouble is we don't really have hard and fast data to prove that."
Pharmacist Zain Razvi said he is pulling some ear drops from his shelves now that he has heard that the manufacturer didn't follow FDA rules to test the drops.
The FDA said manufacturers have to stop making them.
"Now I can't even say that it's not going to harm you," Razvi said.
The FDA said patients should return drops with ingredients on the warning list, and ask their doctor for a substitute prescription.
Guidelines from the Academy of Pediatrics recommend treating ear pain with over-the-counter pain medicine, and not using antibiotics unless you child has a high fever or there is a fluid buildup and discharge in the middle ear.
Medicine labels do not list whether they are FDA approved, but information is available at FDA.gov.