Otherwise Safe Eye Drops and Nasal Sprays Pose Danger When Ingested by Children

By Marguerite McDonald, MD, FACS

Most people consider the over-the-counter eye drops and nasal sprays that they see advertised on TV and pick up at the drugstore to be perfectly safe. And for most people, when correctly used by adults, they are.

But, in the hands of toddlers and young children, these drops and sprays can become dangerous – so much so that the U.S. Food and Drug Administration (FDA) has warned that when children accidentally swallow redness-reducing eye drops or nasal decongestant sprays, the result can be serious harm.

In a review of such incidents between 1985 and 2012, the FDA identified 96 cases of accidental ingestion of eye-whitening eyedrops by children between the ages of 1 month and 5 years. While no deaths were reported, some of the ingestions produced serious adverse events, including decreased heart rate, decreased respiration, sedation, nausea, vomiting, lethargy, mydriasis, hypothermia and even coma. Fifty-three cases required hospitalization.

All the cases were reported to the FDA’s Adverse Electronic Injury System (AERS) and the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance (NEISSS-CADES) databases.

According to the reports, all the products that produced serious symptoms when ingested included the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline, which are included in a variety of products sold under various brand names.

The reports indicated that the children ingested the medication either by sucking or chewing on the bottles, or were found with an empty bottle next to them. In four cases, the child found the product in various places around their homes.

Only a very small ingested amount of these medications can cause serious symptoms. The amounts ingested ranged from 0.6 mL to 1.5 bottles (these products typically are sold in 15 mL and 30 mL bottles). A study by Spiller et al¹ indicates that ingesting 2 mL to 5 mL of tetrahydrolozine 0.05 percent solution can produce coma in a child. Two other articles^2,3 report that 1.5 mL to 3 mL ingested produced severe adverse events such as central nervous system and respiratory depression and bradycardia in an infant and a 2-year-old child.

In 2012, the U.S. Consumer Product Safety Commission proposed requiring child-resistant packaging for redness-relief eye drops and for nasal decongestant sprays. The proposed rule included products containing xylometazoline, although products with that ingredient are not currently sold in the United States. However, the proposal seemingly acknowledges that a growing number of American consumers are ordering medications online that were manufactured in other countries.

The rule is not in effect yet; in the meantime, physicians are encouraged to remind patients to take the following steps to prevent unintentional poisonings:

Keep medicines and household chemicals in their original child-resistant containers.
While most nasal sprays and eye drops are sold in tamper-resistant packaging, some do not come in child-proof containers. Therefore, it is important to store them, and other potentially hazardous substances, out of a child’s sight and reach.
Keep the national Poison Help Line number, 800-222-1222, handy in case of emergency.
When hazardous products are being used, never let young children out of your sight, even if this means taking them with you when answering the phone or doorbell.
Leave original labels on products and read the labels before use.
Always have a light on when giving or taking medications, to be sure you are administering the proper medicine and dosage.
Avoid taking medicine in front of children. Refer to medicine as "medicine," not "candy."
Clean out the medicine cabinet periodically and safely dispose of unneeded and outdated medicines.
In addition, do not put decorative lamps and candles that contain lamp oil where children can reach them. Lamp oil can be very toxic if ingested by children.

Reference(s):

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.

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