Steve Wolf remembers how his son used to howl from the pain of his chronic ear infections.
"They'd keep him up all night," he said. "He'd be crying all night. We'd be calling the emergency room, calling his doctor."
Wolf said the doctor gave his son medication, including prescription ear drops that silenced the crying.
"We found a combination of remedies worked best, combining antibiotics for infection, pain killers like benzocaine to treat the pain," Wolf said.
But over the summer, that key ingredient became the target of an FDA warning that says ear drops with benzocaine can lead to dangerous side effects. In one case, those side effects turned deadly when a baby was given the drops despite warnings not to use on infants younger than one year.
Benzocaine is one of six drugs allowed by regulators for certain medicines but were never evaluated by the FDA for use in ear drops.
"Over the years those medicines have been used a lot," Dr. Jack Borders Jr. said. "And 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 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," he said. "The trouble is we don't really have hard and fast data to prove that."
Pharmacist Zain Razvi said he's pulling these ear drops from his shelves now that he's learned the manufacturer didn't follow FDA rules to test these drops.
"I would say in my own personal opinion, my own clinical judgment, it's not worth it," Razyi said. "It's not going to help you. Now I can't even say that it's not going to harm you."
Instead Dr. Razvi says he'll recommend patients switch to over-the-counter pain medications 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," Razvi said.
Wolf thinks the unapproved drops offered the best relief in his son's case.
"As a parent having used these medications, we found them safe and effective," Wolf said.
Click here to learn more from the FDA about Benzocaine and babies
