Other safety alerts
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| The United States: Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays, which contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline |
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The US Food and Drug Administration (FDA) is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline.
The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma have occurred. 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. Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach.
FDA advised that consumers should store these products out of reach of children at all times. If a child accidentally swallows these eye drops or nasal decongestant spray, seek emergency medical care immediately.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm325729.htm
In Hong Kong, there are 97 registered over-the-counter pharmaceutical products containing ingredients for relieving eye redness and nasal congestion: tetrahydrozoline, oxymetazoline or naphazoline. So far, Department of Health had not received any adverse drug reaction reports on products containing tetrahydrozoline, oxymetazoline and naphazoline. Department of Health will keep vigilant against any updated safety news related to the issue.
Ends/ Friday, October 26, 2012
Issued at HKT 15:00 |
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