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FDA Warns that Eardrops with Benzocaine are Not Approved

Aug 13, 2015

The U.S. Food and Drug Administration (FDA) is warning that eardrops with benzocaine were never approved by the agency and may carry serious side effects. CBS New York reports that there was one case in which the drops were fatal; they were given to a baby despite warnings that they should not be used in children younger than one year of age.

Benzocaine has been approved as a local anesthetic, but the FDA has never evaluated whether or not it is safe to use in eardrops.The agency is coming down on 16 companies that make unapproved prescription ear drops. "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 pediatric otolaryngologist Dr. Jack C. Borders Jr., according to CBS New York. "The trouble is we don't really have hard and fast data to prove that."

"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,'" Dr. Borders said. "There can be serious complications to these medicines."

Pharmacist Zain Razvi told CBS New York that he is taking the product off the shelves in light of the news. "Now I can't even say that it's not going to harm you," he said.

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