Earaches can be painful for any child, and parents may worry about what medicine is best to give their kids.
A new warning from the Food & Drug Administration claims that some pediatricians and pharmacists are giving out unapproved medicine.
[WEB EXTRA: Search Approved Drugs | FDA Ear Drop Warning | FDA Takes Action]
Steve Wolf said he still remembers how painful his son Dashton's chronic ear infections were.
"They'd keep him up all night," said Wolf. "He'd be crying all night. We'd be calling the emergency room, calling his doctor."
Wolf said the doctor gave Dashton medications including prescription ear drops that worked right away.
"We found a combination of remedies worked best, combining antibiotics for infection, painkillers like benzocaine to treat the pain," said Wolf.
But that ingredient is now the target of an FDA warning. The agency said ear drops with benzocaine can lead to dangerous side effects; a baby died after being given the drops.
It happened despite warnings not to use them in infants younger than one year.
Benzocaine is one of six ingredients that are allowed by regulators for certain medicines but were never evaluated by the FDA for use in ear drops.
Those ingredients are:
-benzocaine
-benzocaine and antipyrine
-benzocaine, antipyrine, and zinc acetate
-benzocaine, chloroxylenol, and hydrocortisone
-chloroxylenol and pramoxine
-chloroxylenol, pramoxine, and hydrocortisone.-
"Over the years, those medicines have been used a lot," said Dr. Jack Borders, director of pediatric otolaryngology-head and neck surgery at Children's Hospital. "The FDA is simply pulling the medical community back in to say, 'Wait a minute.' There can be serious complications to these medicines."
Borders supports the FDA clamping down on companies that make and sell 16 different prescription drops for ear pain and swelling that 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," said Borders. "The trouble is -- we don't really have hard and fast data to prove that."
The FDA wants manufacturers to stop making these drugs, but some pharmacists, like Zain Razvi, said they're already pulling these ear drops off their shelves.
Razvi said he'll recommend patients with a prescription for unapproved ear drops switch to over-the-counter pain pills or liquid.
"I think if you treat it with an oral medication that you've known to be effective for other reasons, it will be as equally effective for ear pain, and much more effective than this product," said Wolf.
But Wolf said he still thinks the unapproved drops offer the best relief for his son's earaches, even if he may not be able to find them for much longer.
"As a parent having used these medications, we found them safe and effective," said Wolf.
If you get a prescription for ear drops with benzocaine or other ingredients on the warning list, the FDA recommends you return them and ask your doctor for a substitute prescription to be on the safe side.
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