Wednesday, October 8, 2008
WASHINGTON - Oral cough and cold medicines sold over the counter should not be used in children younger than 4 years old because of the risk of rare complications linked to inappropriate use, a US industry group said on Tuesday.
The Consumer Healthcare Products Association, which represents Procter & Gamble Co, Novartis AG and other companies, said most of the problems occurred in children who were given the wrong dose or who took the medicine accidentally.
"We're doing this out of an abundance of caution," the group's president, Linda Suydam, said.
The association said it made the decision in consultation with the US Food and Drug Administration, which last week held a public meeting to weigh the controversial use of such products in children.
Doctors and consumer advocates at the meeting called on the agency to reject use of the medicines in children as old as 12. They argued nonprescription cold products have never been proven safe and effective, making any risk too great to give them to children.
Complications can include seizures, stroke and other side effects.
FDA officials have already banned marketing of the products to children younger than 2 and have said they are weighing what action to take in older children.
Agency spokeswoman Rita Chappelle said the FDA had no immediate comment.
The industry group limited its ban to those under 4 because an analysis showed most problems occurred in 2-year-olds and 3-year-olds, Suydam said.
Companies this week are rolling out products with packaging that cautions parents not to use the medicines in such young children, she added.
Cough and cold medicines aim to treat cold symptoms such as runny noses and congestion. There is no cure for colds, which are caused by various viruses.
Products available without a prescription include Wyeth's Dimetapp, and Procter & Gamble's NyQuil, Novartis AG's Triaminic, and Johnson & Johnson's Tylenol and PediaCare, among others.
The industry's move only applies to syrups, pills and tablets and does not include nasal sprays, inhaled medicines, lotions or rubs.
Source:Reuters
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