Labels are changing on over-the-counter children's cough and cold medicine to combat misuse

New federal guidelines for children's cough and cold medicines tell parents not to give the drugs to children younger than 4. Labels may not reflect the difference for months, because drug companies are making the change voluntarily; no medicines are being recalled.

Ben Tally, pharmacist at Medicap Pharmacy in Cape Girardeau, said even though over-the-counter cough and cold medications have been used for many years, the adverse side effects of some, such as antihistamines, can cause seizures and even death.

"Decongestants can speed up heart rates, interfere with children's eating patterns and make them irritable," he said.

For an infant with a mild cough or runny nose, Tally suggests using over-the-counter nasal saline drops and a bulb suction, which can help loosen and clear the mucus. He suggested parents use home-based remedies, such as cool air vaporizers, to provide a safer alternative to decongestants and expectorants.

According to a U.S. Food and Drug Administration statement, problems with cough and cold medicines occur when "more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredients are being used."

An FDA study found that between 1996 and 2006, 45 children younger than 2 died after being given decongestant; 41 died from antihistamines. During that same period, nine children between the ages of 2 and 5 died from decongestants and 28 died after being given antihistamines. In some instances, the children were accidentally overdosed when parents and caregivers were unaware each had given a child the medication.

The FDA issued a warning in January, 2008, against giving children under age 2 over-the-counter cold medicines and antihistamines, because of "serious and potentially life-threatening side effects."

The Consumer Healthcare Products Association, which represents companies that make most cold medicines, agreed to update warning labels telling parents not to give the drugs to children under 4. Manufacturers are also introducing new child-resistant packaging and measuring devices.

"We approached them regarding the adverse event reports the FDA had received regarding accidental ingestion by very young children, parental/caregivers accidental overdosing and the need for tamper resistant and dosing devices to accompany their products," wrote Rita Chappelle, FDA spokeswoman, in an e-mail to the Southeast Missourian. She said the FDA continues to study the issue.

Tally said parents and caregivers need to read labels and use only what the child needs.

"I'm an advocate of people using good judgment, and if you're going to err, err on the side of safety," he said.

cwest@semissourian.com

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