FDA Issues Drug Safety Communication about Accidental Ingestion by Children of OTC Eye Drops and Nasal Sprays
Published: Oct 25, 2012
The U.S. Food and Drug Administration (FDA) is warning the public that accidental ingestion by children of over-the-counter (OTC) eye drops used to relieve redness and nasal decongestant sprays can result in serious harm. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. These products are sold under various brand names, as generics, and as store brands.
The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as coma, decreased heart rate, decreased breathing, and sedation (sleepiness) have occurred. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children. Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach.
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