FDA warns consumers to keep eye drops, nasal sprays out of reach of children
Small bottles that deliver drops of medicine to take redness out of eyes or nasal sprays to relieve congestion can be attractive nuisances for young children who are apt to put them in their mouths. However, doing so could cause serious health problems, warns the Food and Drug Administration (FDA).
Eye drops and nose sprays, including those sold over the counter, contain the active ingredients tetahydrozoline, oxymetazoline, or naphazoline – known as imidazoline derivatives. These include the brand names Visine, Dristan and Mucinex, as well as generic and store brands.
One teaspoonful of eye drops or nasal sprays containing imidazoline derivatives is equal to about 5 mL. The FDA has received serious adverse event reports in children who swallow even as little as 1 mL of these drugs.
Between 1885 and 2012, the FDA identified 96 cases in which children ranging in age from 1 month to 5 years accidentally swallowed products containing these ingredients. According to some case reports, children were chewing or sucking on the bottles or were found with an empty bottle next to them.
There were not deaths reported, but more than half of the cases (53) reported hospitalizations because of symptoms that included nausea, vomiting, lethargy, tachycardia, and coma. The FDA suspects that the problem is even greater and that many cases go unreported.
The drugs in eye drops work by narrowing the blood vessels to relieve redness from minor eye irritations. Nose sprays work by constricting 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. The rule has not yet been finalized. The FDA is partnering with CPSC to warn consumers to keep these products safely out of reach of children.
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