FDA: Use Only Approved Prescription Ear Drops

FDA wants to make sure that the next time your child has ear pain requiring a prescription drug, the product has been approved by FDA as safe and effective. That’s why FDA is notifying companies to stop marketing 16 unapproved prescription drugs labeled to relieve ear pain and swelling. These ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by FDA for safety, effectiveness and quality. For years, health care providers have prescribed—and pharmacies have sold—these drug products whose labels did not disclose that they weren’t approved by FDA. Why FDA Is Taking This Action FDA is taking this action under its Unapproved Drugs Initiative, which seeks to protect consumers from drugs that are not proven safe, effective and of high quality. FDA’s action affects only a small percentage of the drugs prescribed to treat pain and swelling that result from otitis media (middle ear infections), otitis externa (outer ear infections), and excess buildup of earwax. There are many FDA-approved drugs for middle and outer ear infections, plus other over-the-counter (OTC) products that are effective for prevention of swimmer’s ear and earwax buildup. What to Do Next If you think you’re using unapproved prescription ear drops, contact your health care provider to discuss alternatives. FDA’s action will not affect legally marketed ear drops. If you are experiencing side effects from unapproved products, consult your health care provider as soon as possible. FDA urges you to report that information online. You or your health care provider can also report an illness or injury related to the use of these products by calling 1-800-FDA-1088.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm453087.htm?source=govdelivery...