NMA: Nonprescription Medicines Academy

Patient Safety Alerts

December 14th, 2012

Serious Adverse Events from Accidental Ingestion of Nonprescription Eye Drops and Nasal Sprays by Children
The FDA is warning the public of possible serious harm if children accidentally ingest nonprescription eye drops or nasal decongestant sprays. The products that have been involved in cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. All 96 reported cases involved children 5 years of age or younger; no deaths were reported, but serious events requiring hospitalization (e.g., coma, decreased heart rate, decreased breathing, sedation) have occurred. Ingestion of as little as 1 to 2 mL can lead to serious adverse events in young children. Most eye drops and nasal sprays currently do not come packaged with child-resistant closures.

Possible Adverse Events Associated With “Energy” Products
The FDA is continuing to investigate reports of illness, injury, or death of people who used dietary supplement or conventional food products marketed as “energy drinks” or “energy shots.” A document summarizing adverse events reported to the FDA between January 1, 2004 and October 23, 2012 in connection with dietary supplement products under the labels 5-Hour Energy, Monster, and Rockstar is available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofFoods/CFSAN.... A similar document summarizing adverse events in connection with food products under the Red Bull label is available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofFoods/CFSAN....