Warning: Nasal Sprays, Eye Drops Pose Serious Risk to Young Children

On Oct. 25, 2012, the Food and Drug Administration (FDA) issued a safety announcement calling attention to accidental poisonings in children who swallowed over-the-counter (OTC) eye drops or nasal sprays containing the active ingredient tetrahydrozoline, oxymetalozine or naphazoline.

These active ingredients are found in many OTC eye drops (to treat red eyes due to minor eye irritation or allergies) and nasal sprays (to relieve stuffy noses due to colds or hay fever). They work by constricting blood vessels both in the outer lining of the eyes (the conjunctiva) and the mucous membranes inside the nose.

OTC eye drops and nasal sprays are available under several well-known brand names, such as VISINE, AFRIN, NEO-SYNEPHRINE, DRISTAN and MUCINEX, and in several less-expensive generic and store-brand versions. For a list of the most commonly used brands, see the FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm325257.htm.

The FDA warned that accidental ingestion by a child of as little as 1 or 2 milliliters — a fraction of a teaspoon — of nasal sprays or eye drops could result in serious, potentially life-threatening adverse events. The agency’s warning was based on an analysis of 96 cases, reported between 1985 and 2012, of children accidentally swallowing one of these products. The children’s ages ranged from 1 month to 5 years. While no deaths were reported, 53 of the children (55 percent) were hospitalized for signs of toxicity, including nausea, vomiting, sleepiness, rapid heart rate and coma.

Yelena Maslov, an FDA pharmacist, emphasized that “underreporting of these types of events is common, so it is possible there are additional cases that we may not be aware of.” The FDA has often estimated that only 1 out of 10 adverse drug reactions is actually reported.

To read the full FDA consumer safety announcement, visit the FDA’s website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm325220.htm.

What You Can Do

All pediatric poisonings from accidental ingestion of prescription and OTC medications are preventable adverse events. If you have young children living in your home or if you visit the homes of relatives or friends who have young children, take appropriate precautions to ensure that children cannot access and accidentally ingest your medications.

Ideally, medication bottles and containers should include child-resistant caps and should be kept in a locked container box or cabinet out of the reach of small children. Never leave medicines on a counter or table accessible to children. The FDA also advises that you avoid taking medicines in front of young children, who like to imitate adults.

The FDA has made available on its website (at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm272905.htm) an educational video that reviews how to prevent harm to children by locking up your medicine.

If you suspect that a child accidentally ingested a prescription or OTC medication, immediately contact your local poison-control center (1-800-222-1222) and a health care provider. If the child appears to be having a serious reaction to the medication, immediately call 911.

It is important to report to MedWatch: The FDA Safety Information and Adverse Event Reporting Program any serious adverse event in children as a result of unintentional poisoning with a prescription or OTC medication.