The FDA is warning healthcare professionals and 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 and fatal adverse events. The FDA has reviewed cases of accidental ingestion occurring in children <5 years old.
The involved eye drops and nasal sprays contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. Ingestion of only 1–2mL can lead to serious adverse events such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma.
These products are sold under various brand names, as generics and store brands (eg, Visine AC, Opti-clear, All Clear Ophthalmic Solution, Naphcon A, Afrin, Mucinex Nasal Spray, Neo-Synephrine, and Sinex Nasal Spray).
The FDA recommends that consumers store these products out of reach of children at all times. If a child accidentally swallows these eye drops or nasal decongestant spray, call the National Capital Poison Center (800) 222-1222 and seek immediate medical care.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325729.htm.