FDA Drug Safety Podcast: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays

Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays
Joan Powers, a Consumer Safety Officer in the Division, will provide you with additional information about this Communication.
Guest Speaker: On October 25, 2012, the FDA is warning the public that accidental ingestion (swallowing) by children of non-prescription, over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious harm. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. These products are sold under various brand names, as generics, and as store brands.
The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; but serious events requiring hospitalization-such as coma, decreased heart rate, decreased breathing, and sedation have occurred. Ingestion of only a small amount of 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.
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, call the toll-free Poison Help line (1-800-222-1222) and seek emergency medical care immediately.
To protect young children from ingesting these products, earlier this year the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule requiring child-resistant packaging for redness-relief eye drops and nasal decongestant sprays.
*The proposed rule also covers products that contain xylometazoline, but products containing xylometazoline are not currently marketed.
At this time FDA recommends that Healthcare Professionals be aware of the following:

Cases of accidental ingestion of over-the-counter redness-relief eye drops or nasal decongestant sprays containing the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline have resulted in serious adverse events in young children 5 years of age and younger.
Parents and caregivers should be advised to call the toll-free Poison Help line (1-800-222-1222) and to seek emergency medical care immediately if their child accidentally swallows these eye drops or nasal decongestant sprays.
Consumers should be advised to store these products out of reach of children at all times.
Adverse events involving these eye drops or nasal decongestant sprays should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary and Product List, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.
Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.

Related Information

Contact FDA

Toll Free

(855) 543-3784, or

(301) 796-3400

druginfo@fda.hhs.gov

Human Drug Information

Division of Drug Information (CDER)
Office of Communications
Feedback Form
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993