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FDA Warns About Toxic Effects of Eye Drops and Decongestant Sprays in Young Children

The Food and Drug Adminisration (FDA) is warning parents to keep  over-the-counter (OTC) eye drops used to relieve redness or nasal decongestant sprays away from places where children can get a hold of them.

FDAAccording to the FDA, these products—which contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline (known as imidazoline derivatives)—are dangerous, if ingested by children. The products are sold under various brand names such as Visine, Dristan and Mucinex, as well as in generic and store brands.

“In the hands of young children who are apt to swallow them, they can cause serious health consequences,” says pharmacist Yelena Maslov, Pharm.D., at the Food and Drug Administration (FDA).

Maslov explains that one teaspoon of eye drops or nasal spays containing imidazoline derivatives is equal to about 5 mL, and that harm has been reported from swallowing as little as 1 mL to 2 mL. “Children who swallow even miniscule amounts of these products can have serious adverse effects,” she says.

Between 1985 and 2012, FDA identified 96 cases in which children ranging from 1 month to 5 years accidentally swallowed products containing these ingredients. Cases were reported by both consumers and manufacturers to government databases monitored by FDA. According to some case reports, children were chewing or sucking on the bottles or were found with an empty bottle next to them.

The FDA reports there were no deaths reported, but more than half of the cases (53) reported hospitalization because of symptoms that included nausea, vomiting, lethargy (sleepiness), tachycardia (fast heart beat), and coma.

“Under reporting of these types of events is common, so it is possible there are additional cases that we may not be aware of,” says Maslov.

These products are only meant for use in the eyes or nose. In the eyes, the ingredients work by narrowing blood vessels to relieve redness from minor eye irritations. In the nose, they constrict blood vessels to relieve nasal congestion due to the common cold, hay fever, or allergies.

In January, 2012, the U.S. Consumer Product Safety Commission (CPSC) proposed a rule to require child-resistant packaging for all products containing at least 0.08 mg of an imidazoline derivative. However, this rule has not been finalized. In addition, FDA’s Division of Medication Error Prevention and Analysis (DMEPA) is partnering with CPSC to warn consumers about the need to keep these products safely out of the reach of children.

If a child accidentally swallows OTC redness-relief eye drops or nasal decongestant spray, call your local poison control center (1-800-222-1222) immediately. Experts are available all day, every day at these centers. If necessary, poison center staff will immediately help get emergency medical services to your home. Program this number into your home and cell phones so you will have it when you need it. Post it on the fridge so it is in plain sight.

To help avoid a child’s accidental exposure to any medication, parents and other caregivers should:

  • Store medicines in a safe location that is too high for young children to reach or see.
  • Never leave medicines or vitamins out on a kitchen counter or at a sick child’s bedside.
  • If a medicine bottle does have a safety cap, be sure to re-lock it each time you use it.
  • Remind babysitters, house guests, and visitors to keep purses, bags, or coats that have medicines in them away and out of sight when they are in your home.
  • Avoid taking medicines in front of young children because they like to mimic adults.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

 

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