Common redness reducing eye drops and decongestant nasal sprays may pose a much more serious health threat to small children than previously thought, according to federal health officials.
The FDA released a drug safety communication yesterday, warning parents about risks associated with accidental ingestion of many common over-the-counter eye drops and nasal sprays, which can make children very ill and possibly lead to more severe side effects, such as coma.
According to reports received by the agency, adverse reactions have been seen among young children under the age of 5 years old, often leading to coma, decreased heart rate, decreased breathing and sleepiness.
The products listed in the warning all contain the active ingredient tetrahydrozoline, oxymetazoline, or naphazoline. Many of these products are sold as brand name products, generic products and under store brand labels. These products are typically sold in 5 mL and 30 mL bottle packages and are not sold with child-resistant packaging, making it easy for children to reach the product.
Officials warn that only 1 to 2 mL are required to cause such serious side effects in young children, which is approximately half a teaspoon of liquid or less. Researchers found a small dose of 1.5 mL to 3 mL of tetrahydrozoline 0.05% solution produced central nervous system and respiratory depression and bradycardia in a 25 day old infant and a 2 year old child. Additionally, 2 to 5 mL of the solution is enough to induce coma in a small child.
The FDA received 96 complaints of accidental eye drop or nasal spray swallowing in young children between 1985 and October of 2012 through its Adverse Event Reporting system. All the cases involved children under the age of 5 years.
In many cases the children were found chewing or sucking on the bottles or the bottles were found empty near them. In 53 cases, hospitalization occurred due to severe symptoms such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis stupor, hypothermia, drooling and coma.
The Consumer Product Safety Commission (CPSC) published a proposal requiring child-resistant packaging for redness relief eye drops and nasal decongestant spray products along with any products containing xylometazoline.
Products involved in the FDA warning containing tetrahydrozoline, naphazoline or oxymetazoline are Visine, Walgreens, Tyzine, GNP, Opti-Clear, Tetrahydrozoline, Today’s Health, Leader, Ak-Con, Napha Forte, Naphazoline, All Clear, Opcon-A, Naphcon A, 12 Hour, Afrin, Dristan, Equaline, Equate, Good Sense, Mucinex, Neo-Synephrine, Publix, Select Brand, Sinex, Sudafed, and Tope Care brand and products.
The FDA warns parents to store these over-the-counter drugs out of the reach of children. If a child ingests any of these products call the poison help line at 800-222-1222 and seek emergency medical attention.