FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events.
The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported.
Serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma 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.
BACKGROUND: 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. These products are sold under various brand names, as generics, and as store brands (see List of Products, included in the Drug Safety Communication, below).
RECOMMENDATION: Consumers should 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 (1-800-222-1222) and seek emergency medical care immediately.
|Products containing tetrahydrozoline||Products containing naphazoline||Products containing oxymetazoline|
|Visine Original||Visine A||Visine L.R.|
|Visine A.C.||Ak-Con Ophthalmic Solution||12 Hour Nasal Decongestant Nasal Spray|
|Visine Advanced Relief||Napha Forte Ophthalmic Solution||Afrin Extra Moisturizing Nasal Spray|
|Visine Totality||Naphazoline HCl Ophthalmic Solution||Afrin No Drip Severe Congestion Nasal Spray|
|Visine Maximum Redness Relief Formula||All Clear Ophthalmic Solution||Afrin No Drip Sinus Nasal Spray|
|Walgreens Redness Reliever Advanced Eye Ophthalmic Solution||All Clear AR Maximum Strength Ophthalmic Solution||Afrin No Drip Sinus Extra Moisturizing Nasal Spray|
|Tyzine Nasal Spray||Opcon-A Ophthalmic Solution||Afrin Original Nasal Spray|
|GNP Original Eye Drops||Naphcon A Ophthalmic Solution||Afrin Severe Congestion Nasal Spray|
|Opti-clear Ophthalmic Solution||Walgreens Eye Allergy Relief Drops||Dristan 12 Hour Nasal Spray|
|Tetrahydrozoline HCl Ophthalmic Solution||Equaline 12 Hour Nasal Spray|
|Today’s Health Original Eye Drops||Equaline 12 Hour Extra Moisturizing Nasal Spray|
|Leader Eye Drops Regular Formula Ophthalmic Solution||Equate Nasal Spray|
|GNP 12 Hour Nasal Spray|
|GNP 12 Hour No Drip Nasal Spray|
|GoodSense 12 Hour Nasal Spray|
|Leader 12 Hour Nasal Spray|
|Maximum Strength Nasal Decongestant Nasal Spray|
|Mucinex Full Force Nasal Spray|
|Mucinex Moisture Nasal Spray|
|Nasal Relief Spray|
|Neo-Synephrine 12 Hour Nasal Spray|
|Publix Nasal Spray|
|Select Brand Nasal Spray|
|Sinex Nasal Spray|
|Sudafed OM Nasal Spray|
|Today’s Health Nasal Relief Nasal Spray|
|Tope Care 12 Hour Nasal Spray|
|Walgreens Anefrin Nasal Spray|
*List may not be all-inclusive. Check the Drug Facts label on the package to determine the active ingredients of any over-the-counter product.
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