FDA warns patients, parents about dangerous ear drops

FDA warns patients, parents about dangerous ear drops

(NPN) - The Food and Drug administration has issued a warning on ear drops that some pediatricians and pharmacists are prescribing to ail children's ear aches.

The FDA's warning targets a particular ingredient in the ear drops, benzocaine, which the organization says can lead to dangerous side effects. The ingredient has even proven to be fatal, as a at least one baby has died after receiving the drops that are not intended for infants.

Benzocaine is one of six drugs that are allowed by regulators for certain medicines, but were not evaluated for use by the FDA in ear drops.

"Over the years, those medicines have been used a lot," said Jack C. Borders, Jr., the director of Pediatric Otolaryngology at the Children's Hospital of Georgia. "And the FDA is simply pulling the medical community back to say, 'wait a minute.' There can be serious complications to these medicines."

Borders said he supports the FDA clamping down on companies that make and sell 16 different prescription drops for ear pain and swelling, none of which were approved by the FDA.

"There are a lot of pediatricians 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 the ear drops from his shelves after learning that the manufactures didn't follow FDA rules.

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

The pharmacist said he'll recommend patients use an alternative treatment.

However, Steve Wolf said the ear drops have worked for his son's chronic ear aches.

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

The FDA is asking patients to return ear drops that contain ingredients on the warning list and ask their doctor for a substitute prescription.

The warning list can be found here.

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