Over-The-Counter Eye Drops and Nasal Sprays: Serious Adverse Events from Ingestion by Children

Posted on October 25, 2012 by

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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.

List of Products*

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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 © 2012 US Food Safety Corporation. No copyright claim is made for portions of this blog and linked items that are works of the United States Government, state governments or third parties

Posted in: Family safety