Doctors want FDA to halt cold medicines for kids

By Susan Heavey

BELTSVILLE, Maryland (Reuters) - Over-the-counter cough and cold medicines should not be sold for young children because they are unproven and can be dangerous, doctors and consumer advocates said on Thursday, despite objections from industry representatives.

Experts urged U.S. Food and Drug Administration officials to ban sales of the products, which take in billions of dollars in annual sales and include versions of Wyeth's Dimetapp and Procter & Gamble Co's NyQuil, for children, especially those ages 2 to 6.

"Cough and cold medications ... have not been proven to be effective and they have clear risks. It is time for them to be reevaluated," Dr. Wayne Snodgrass of the University of Texas Medical Branch, said at an FDA meeting to discuss whether the nonprescription remedies should be sold for children.

Parents want their children to feel better, but "it is too easy to administer too much or not enough," said Mimi Johnson, a health policy associate at the National Consumers League.

Other medicines include Novartis AG's Triaminic and Johnson & Johnson's Tylenol and PediaCare, among others.

Such products including NyQuil already caution parents to talk to their doctors before giving them to children under 6.

The drugs have been sold for decades and aim to combat runny noses, coughs, congestion and other symptoms. But they can potentially increase the risk of stroke, seizures and other complications, often because of dosing errors.

They also have never been proven to work, the doctors said.

In January, the FDA recommended against their use in children up to 2 years old after 14 products aimed at that age group were voluntarily recalled. It is still deciding whether to take action for children of other ages.

An FDA panel of outside experts last year said they should not be given to children under age 6.

Unlike some children's medicines, these drugs were allowed on the market under rules for over-the-counter products that do not require data showing safety and efficacy. Instead, data were extrapolated from adults.

Industry representatives rejected the concerns, saying the medicines are safe for children over 2 years old when used as directed.

Most reported problems occur when kids accidentally ingest the medicines or are given the wrong dose, said Linda Suydam, head of the Consumer Healthcare Products Association (CHPA).

"There really isn't a safety problem," said Suydam, whose group represents over-the-counter drugmakers.

Companies are launching several studies to look at individual ingredients, she added. They are also educating parents and changing packages to improve proper dosing.