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Even miniscule amounts of certain over-the-counter eye drops (e.g., Visine) and nasal decongestant sprays (e.g., Mucinex) can be harmful if accidentally ingested by children, the FDA cautioned on Thursday.
The warning applies to both brand-name and generic products containing the imidazolines tetrahydrozoline, oxymetazoline, or naphazoline (see the FDA's drug safety communication for a product list).
The agency cites 96 cases of accidental ingestion in children aged 5 years or younger since 1985. No deaths have been reported, but 53 children have been hospitalized for adverse events such as coma, decreased respiration, lethargy, tachycardia, and vomiting.
Earlier this year, the U.S. Consumer Product Safety Commission proposed a rule that would require childproof packaging for drugs containing 0.08 mg or more of imidazolines.
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LINK(S):
FDA MedWatch safety alert (Free)
FDA drug safety communication (Free)
CPSC proposal (Free PDF)