FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays

Safety Announcement
Additional Information for Consumers and Parents/Caregivers
Additional Information for Health Care Professionals
Data Summary
List of Products
References

Safety Announcement

[10-25-2012] The U.S. Food and Drug Administration (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 (see List of Products below).

Facts about OTC redness-relief eye drops and nasal decongestant sprays

These products contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline.
In the eyes, these ingredients work by narrowing blood vessels to relieve redness due to minor eye irritations. In the nose, they work by narrowing blood vessels to relieve nasal congestion due to the common cold, hay fever, or allergies.
These products are safe when used in the eyes or the nose as directed, but if ingested, they may cause serious and life-threatening adverse events.

The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger (see Data Summary below). 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.

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.

To protect young children from ingesting these products, earlier this year the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule¹* requiring child-resistant packaging for redness-relief eye drops and nasal decongestant sprays.

*The proposed rule also covers products that contain xylometazoline; however products containing xylometazoline are not currently marketed.

Additional Information for Consumers and Parents/Caregivers

Serious harm may result from accidentally swallowing over-the-counter (available without a prescription) redness-relief eye drops or nasal decongestant sprays containing the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. These products are intended for use in the eyes or nose only.
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.
Store these products out of reach of children at all times (see List of Products below).
Report side effects or medication errors from the use of these eye drops or nasal decongestant sprays to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

Additional Information for Health Care Professionals

Cases of accidental ingestion of over-the-counter redness-relief eye drops or nasal decongestant sprays containing the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline have resulted in serious adverse events in young children 5 years of age and younger.
Advise parents and caregivers to call the National Capital Poison Center (1-800-222-1222) and to seek emergency medical care immediately if their child accidentally swallows these eye drops or nasal decongestant spray.
Advise consumers to store these products out of reach of children at all times.
Report adverse events or medication errors involving these eye drops or nasal decongestant sprays to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

Data Summary

FDA identified 96 cases of accidental ingestion of products containing tetrahydrozoline, oxymetazoline, or naphazoline by young children, reported between 1985 and October 2012 to the Agency’s Adverse Event Reporting System (AERS and FAERS) databases and to the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database. The children ranged in age from 1 month to 5 years. Fifty-three cases reported hospitalization due to symptoms including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma.
The cases reported that the children were either chewing or sucking on the bottles or were found with an empty bottle next to them. In five cases, the children were found playing with the bottle; the case reports did not state if the children had ingested the drug, however they exhibited symptoms associated with ingestion of the products. In four cases, the child gained access to the product by finding it in various places around his or her home.
Sixty-two cases reported the name of the product that had been ingested; these cases included various tetrahydrozoline, oxymetazoline, and naphazoline products. Thirty-one of the 62 cases also reported an amount of the product that was ingested. The amounts ranged from 0.6 mL to one and one-half bottles (these products are packaged in 15-mL and 30-mL bottles). An article in the medical literature by Spiller et al.¹ states that 2 mL to 5 mL of tetrahydrozoline 0.05% solution is capable of producing coma in a child. Additionally, two literature reports indicate that a 1.5 mL to 3 mL volume 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.^2,3

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.

References

Spiller HA, Rogers J, Sawyer TS. Drug facilitated sexual assault using an over-the-counter ocular solution containing tetrahydrozoline (Visine®). Legal Medicine 2007;9:192-5.
Katar S, Taskesen M, Okur N. Naloxone use in a newborn with apnea due to tetrahydrozoline intoxication. Pediatr Int 2010;52:488-9.
Tobias JD. Central nervous system depression following accidental ingestion of Visine eye drops. Clin Pediatr (Phila). 1996;35:539-40.