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Unapproved Ear Drops Targeted by FDA

Posted 1 Jul 2015 by Drugs.com

WEDNESDAY, July 1, 2015 – The prescription drops your child is using for ear pain could be among 16 unapproved medications targeted this week by the U.S. Food and Drug Administration. These drugs, prescribed and sold for years to relieve ear pain and swelling, have not been evaluated for safety, quality and effectiveness, the agency said Wednesday. The agency notified the drugs' makers to stop marketing the drops following a few reports of local allergic reactions of the ear, eye, face, neck and mouth. The drops can also cause itching, stinging, burning and irritation of the ear, according to an FDA news release. "If we don't know whether these drugs have any benefits, we should not accept any possible risk of side effects," said the FDA's Dr. Charles Lee in the news release. The FDA did not release the names of the companies or the medications involved, but did note that "unapproved ... Read more

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