By Tasnima Nabi, PharmD Candidate c/o 2016
The FDA has issued warnings on accidental ingestion of over-the-counter eye drops and nasal sprays because they can cause serious harm in children at and under the age of five. Ingestion of as little as 0.6 ml of OTC nasal decongestants and redness-relief eye drops has been reported to require hospitalization.1
The FDA collected data reported to their Adverse Event Reporting System databases and to the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 1985 and 2012 on accidental ingestion of products containing tetrahydrozoline, oxymetazoline, or naphazoline.1 Tetrahydrozoline, oxymetazoline, and naphazoline are imidazolines used to narrow blood vessels in irritated eyes and congested noses. When used in topical and nasal administration, there is little absorption of imidazolines into the general circulation. Oral ingestion, however, leads to systemic effects.2Of the 96 cases, 53 required hospitalization due to nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma.1
A common misconception is that OTC eye drops and nasal sprays are safe and harmless because they do not need prescriptions and even though they are used in very sensitive areas. However, it is important to stress that medicines are safe and harmless when used as directed.
As a general precaution, medicine should be kept out of reach of children. A large part of this problem, however, lies in how OTC eye drops and nasal sprays are bottled; neither is contained in child-resistant packaging. Although a proposal was made by the U. S. Consumer Product Safety Commission in January 2012 to require CR packaging of products containing at least 0.08 mg of imidazole derivatives, the rule still has not been finalized.1,2 There is no doubt that a push for child-resistant packaging on these medicines will greatly reduce the harm due to accidental ingestion.
- FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays. U. S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm325257.htm#list. Accessed on November 21, 2012.
- Ballot Vote Sheet. United States Consumer product Safety Comission Web site. http://www.cpsc.gov/library/foia/foia12/brief/imidazolines.pdf. Accessed on November 21, 2012.