FDA warns about unapproved ear drops


Steve Wolf still remembers how his son Dashton used to howl from the pain of his chronic ear infections.

"They'd keep him up all night. He'd be crying all night. We'd be calling the emergency room, calling his doctor," he explained.

Wolf says the doctor gave him  medication including prescription ear drops that silenced the suffering.

"We found a combination of remedies worked best, combining antibiotics for infection, pain killers like benzocaine to treat the pain," he said.

But that ingredient is now the target of a Food and Drug Administration warning which says ear drops with benzocaine can lead to dangerous side effects. It turned fatal in one severe case when a baby was given the drops, despite warnings not to use in infants younger than one year. 

Benzocaine is one of six drugs that are 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. And the FDA is simply pulling the medical community back in to say, Wait a minute. There can be serious complications to these medicines," said Dr. Jack C. Borders, Jr., Director of Pediatric Otolaryngology.

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," Borders said. "The trouble is we don't really have hard and fast data to prove that."

Pharmacist Dr. Zain Razvi says he's pulling these ear drops from his shelves,  now that he heard the manufacturer didn't follow FDA rules to test the drops. And, the FDA says manufacturers have to stop making them.

"I would say in my own personal opinion, my own clinical judgment, it's not worth it. It's not going to help you. Now I can't even say that it's not going to harm you," Razvi said.

Razvi says 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," he said. "It will be as equally effective for ear pain and much more effective than this product."

Meantime, Wolf still thinks the unapproved drops offer the best relief for his son's ear aches, though it's doubtful he'll be able to find them for much longer.

"As a parent having used these medications, we found them safe and effective," Wolf said.

The FDA says patients should return drops with ingredients on the warning list, and ask their doctor for a substitute prescription.

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