Unapproved ear drops warning

Earaches for any child can be painful and parents may worry about what medicine is best to give their kids. Now, a new warning from the FDA claims that some pediatricians and pharmacists are giving out unapproved medicine.

Steve Wolf still remembers how his son Dashton Wolf 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 said.

Steve says the doctor gave him  medication including prescription eardrops that silenced the suffering.

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

But that ingredient is now the target of an FDA warning which says ear drops with benzocaine can lead to dangerous side effects that 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.

Doctor Borders, a Director of Pediatric Otolaryngology, supported 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. the trouble is we don’t really have hard and fast data to prove that,” he explained.

Pharmacist Zain Razvi says he has pulled these ear drops from his shelves.

“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,” he said.

The pharmacist said he will 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 Dr. Razvi.

But Steve still thinks the unapproved drops offer the best relief for his son’s ear aches, though he is doubtful he will be able to find them for much longer.

“As a parent having used these medications, we found them safe and effective,” he said.

The FDA says patients should return drops with ingredients on the warning list and ask their doctor for a substitute prescription. Since medicine labels don’t list whether or not they are FDA approved, you can head to the FDA’s website to find out.