October 25, 2012 — The U.S. Food and Drug Administration (FDA) has published a Safety Announcement warning about the dangers of children accidentally swallowing eye drops or nasal decongestant sprays. Most of these products are sold without child-safety caps. If children swallow even tiny amounts of the product, they may suffer serious and life-threatening adverse events.
The FDA is concerned about the safety of product that contain the ingredients tetrahydrozoline, oxymetazoline, or naphazoline. These drugs narrow blood vessels, which reduces redness in the eyes, and reduces congestion in the nose. Unfortunately, when even tiny amounts are swallowed, they can have serious complications.
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.” Furthermore, medical literature states that ingestion of 2-5 mL of tetrahydrozoline 0.05% solution can cause coma in a child.
Symptoms that the products have been ingested include:
- Nausea, vomiting
- Lethargy, sleepiness, sedation, stupor
- Decreased respiration
- Rapid heart rate (tachycardia)
- Decreased heart rate (bradycardia)
- Low blood pressure (hypotension)
- High blood pressure (hypertension)
- Dilated pupils (mydriasis)
- Low body temperature (hypothermia)
Between 1985 and October 2012, the FDA has identified 96 cases of young children accidentally ingesting a nasal decongestant or eye drop, of whom 53 children required hospitalization. The children ranged in age from one month to 5 years old. They were often discovered chewing or sucking on the bottles, or found with an empty bottle next to them.
The FDA is recommending that parents and caregivers should call the National Capital Poison Center (1-800-222-1222) and seek emergency medical attention if their child swallows eye drops or nasal decongestant sprays. Furthermore, the products should be kept out of the reach of small children at all times.
Earlier this year, the Consumer Products Safety Commission (CPSC) proposed a rule that would require child-resistant packaging on eye drops and nasal decongestant sprays.
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