Over-The-Counter Eye Drops & Nasal Sprays: Serious Complications from Accidental Ingestion by Children

Consumers and Pediatrics healthcare personnel are informed by the FDA that Over-The-Counter Eye Drops & Nasal Sprays’ accidental ingestion by children for the relief of redness and nasal decongestion can result to serious and even life-threatening adverse events.

Background of Over-The-Counter Eye Drops & Nasal Sprays

Over-The-Counter Eye Drops & Nasal Sprays are sold, as generics, under various brand names. They are redness-relief eye drops and nasal decongestant sprays with no child-resistant closures.

FDA Alert on Over-The-Counter Eye Drops & Nasal Sprays

Cases of accidental ingestion of over-the-counter eye drops and nasal sprays were reviewed by the FDA among children aged 5 years old and younger. Accidental ingestion of the active ingredients tetrahydrozoline, oxymetazoline, or naphazolin can cause serious and life-threatening adverse events including nausea, hypothermia, tachycardia, hypotension, and coma, among others.

Recommendation on Over-The-Counter Eye Drops & Nasal Sprays

“Consumers should store these products out of reach of children at all times. 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.”

Contacting the FDA to report cases with Over-The-Counter Eye Drops & Nasal Sprays

In case of detection of adverse events or side effects related to the use of Over-The-Counter Eye Drops & Nasal Sprays, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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