October 8, 2008

Cold Medicine Warning Expands to Kids Under 4


Cough and cold medicines sold over the counter will soon carry warnings that the drugs should not be given to kids under age 4.

Makers of the drugs volunteered to add the warning labels after doctors and government advisers said the medicines, such as Tylenol, Robitussin and Sudafed are risky and may not work. Last year, the companies followed government recommendations and stopped selling OTC decongestant drops and sprays for children 2 years and younger.

Pediatric antihistamines will carry a warning that they should not be used to sedate children of any age, the trade group Consumer Healthcare Products Association said Tuesday. Physicians in North Jersey welcomed the warnings. "I'm very happy to hear that," said Dr. Steven Stravinski, chief of pediatrics at Holy Name Hospital in Teaneck. "There was no evidence they [cough and cold medicines] worked for certain in children, or for anybody. There are risks in children because decongestants are cardiac stimulants."

Parents often give children several different drugs to relieve symptoms without realizing most of the medicines contain the same ingredients, said Dr. Alexander Hyatt, chief of pediatrics at Englewood Hospital and Medical Center.

"There have been deaths attributed to inadvertent overdose because different products were the same medication," Hyatt said.

The U.S. Food and Drug Administration began reviewing the safety of OTC medicines two years ago after it got reports of 123 children's deaths between 1969 and 2006 linked to OTC and prescription decongestants and antihistamines. The risk of overdose is greatest in 2- and 3-year-olds, said Linda Suydan, president of the trade group.

The drugs are safe for young children if parents follow the recommended dosage, said Michael Fedida, chief pharmacist at J & J Pharmacy in Teaneck. "Sometimes they think if half a teaspoon is good, a whole teaspoon is better," he said.

Fedida said parents should be careful with toddlers up to age 4 because some of the drugs have a sedating effect. The medications also have multiple ingredients and "if children have a reaction, it's very difficult to tell which ingredient caused the reaction," he said.

If the industry wants to continue selling the drugs, it will probably make them a prescription drug for that age group, or put them in a special category to be kept behind the counter, he said. "They generate a lot of revenue," Fedida said.

Antihistamines should be used only in carefully prescribed doses for children with allergies, said Dr. Ellen Kaplan, chief of pediatric pulmonology at Hackensack University Medical Center. "We don't use OTC medicines in general because they don't work," she said.


This article contains material from Bloomberg News.

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