October 25, 2012 — In response to dozens of adverse event reports, the U.S. Food and Drug Administration (FDA) has published a Safety Communication to warn parents and caregivers to keep eye drops and nasal decongestant sprays out of the reach of children. If a child swallows even a tiny amount of the product, they can suffer life-threatening coma or death. Most of the products do not have child-resistant caps, although the Consumer Products Safety Commission (CPSC) proposed a requirement earlier this year.
From 1985 until October 2012, there were 96 reported cases of children swallowing eye drops or nasal decongestant sprays. Of these children, 53 had to be hospitalized. Most of the children were between one month and 5 years old, and caregivers discovered them sucking or chewing on a bottle, or near an empty bottle.
The active ingredients in these products (tetrahydrozoline, oxymetazoline, or naphazoline) narrow blood vessels — in the eyes, this reduces redness, and in the nose, it relieves congestion.
Unfortunately, the drugs can have life-threatening complications if they are swallowed. According to the FDA: “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.” Studies in medical literature suggest that as little as 2-5 mL of tetrahydrozoline 0.05% solution could induce a coma in a young child.
If the drugs are ingested, they may cause the following adverse symptoms:
- Nausea, vomiting
- Decreased breathing
- Sleepiness, sedation, lethargy, or stupor
- Increased heart rate (tachycardia) or decreased heart rate (bradycardia)
- Increased blood pressure (hypertension) or decreased blood pressure (hypotension)
- Dilated pupils (mydriasis)
- Low core body temperature (hypothermia)
- Drooling
- Coma
FDA recommends that parents and caregivers should keep eye drops and nasal decongestant sprays out of the reach of young children at all times. If a child ingests the products, parents should seek emergency medical attention immediately and call the National Capital Poison Center (1-800-222-1222).
Do I have a Product Liability Lawsuit?
The Schmidt Firm, PLLC is currently accepting nasal decongestant and eye drop induced injury cases in all 50 states. If your child or somebody you know has been injured by ingesting an eye drop or nasal decongestant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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