November 7, 2012
FDA: Pharmacists Should Warn Customers About Dangers of Some OTC Drops, Sprays
Washington, D.C.—Pharmacists should warn parents purchasing OTC redness-relief eye drops and nasal decongestant sprays that those products present significant danger to children who swallow them.
The FDA issued a drug safety communication, noting that OTC eye drops and nasal sprays containing the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline have caused serious reactions when ingested by children 5 years old and younger. While no deaths were reported, the FDA reported serious events requiring hospitalization, including coma, decreased heart rate, decreased breathing, and sedation. Complicating the problem is that effects can occur with only a small amount of the products—1-2 mL, far less than a teaspoon—and that most redness-relief eye drops and nasal decongestant sprays do not have child-resistant closures.
The FDA recommends that pharmacists and other health care professionals caution consumers to store the products out of reach of children at all times. In cases of accidental ingestion, parents or caregivers should call the toll-free Poison Help Line (1-800-222-1222) and seek emergency medical care immediately.
Parents should be advised to:
• Store medicines in a safe location that is too high for young children to reach or see.
• Never leave medicines or vitamins out on a kitchen counter or at a sick child's bedside.
• If a medicine bottle does have a safety cap, be sure to relock it each time you use it.
• Remind babysitters, houseguests, and visitors to keep purses, bags, or coats that have medicines in them away and out of sight when they are in your home.
• Avoid taking medicines in front of young children because they like to mimic adults.
“In the hands of young children who are apt to swallow them, they can cause serious health consequences,” said FDA pharmacist Yelena Maslov, PharmD. "Children who swallow even miniscule amounts of these products can have serious adverse effects.”
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.
From 1985 to October 2012, 96 cases of accidental ingestion of products containing tetrahydrozoline, oxymetazoline, or naphazoline by young children were reported to the FDA’s Adverse Event Reporting System databases and to the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance database. In the children, ranging in age from 1 month to 5 years old, 53 cases resulted in hospitalization due to symptoms such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma.
“Underreporting of these types of events is common, so it is possible there are additional cases that we may not be aware of,” Maslov said.
In many of the cases, children were discovered chewing or sucking on the bottles or were found with an empty bottle next to them.
The products, which constrict blood vessels to relieve eye redness or relieve nasal congestion, are among the biggest selling in the market segment with brand names such as Visine, Dristan, Afrin, Mucinex, and Neo-Synephrine. Store brand versions also have been involved in the adverse effects. A list of products is available here, but the FDA warns it may not be all-inclusive, suggesting that the drug facts label be checked on packages.
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