FDA Warns of Serious Adverse Events from Accidental Ingestion by Children of Over-the-Counter Eye Drops and Nasal Sprays

 The FDA is warning the public that accidental ingestion (swallowing) by children of over-the-counter (OTC; available without a prescription) 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 the FDA occurred in children five 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. 2 mL to 5 mL of tetrahydrozoline 0.05% solution is capable of producing coma in a child. 1.5 mL to 3 mL produced severe adverse events such as central nervous system and respiratory depression, and bradycardia in a 25-day-old infant and a 2-year-old child.


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. To protect young children from ingesting these products, earlier this year the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule requiring child-resistant packaging for redness-relief eye drops and nasal decongestant sprays.


See the FDA Safety Announcement