October 2, 2008 / 5:59 PM / 11 years ago

Doctors want FDA to halt cold medicines for kids

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.

Shelves that used to hold infants' nonprescription cough and cold products stand empty in a Washington drug store October 11, 2007. REUTERS/Kevin Lamarque

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.

Over-the-counter cough and cold products for children and adults brought in $3.6 billion in 2007, according to CHPA’s Website, and roughly 95 million packages are sold in the United States each year.

Without the children’s versions, parents could simply turn to stronger adult formulations or potentially risky alternatives, CHPA and some other physicians said.

There is no cure for the common cold, but parents often feel pressured to use a product to help soothe their sick child, other physicians said. And while the American Academy of Pediatricians now rejects use of such remedies, some doctors still suggest them.

Intense marketing is part of the issue. Medicines are made to taste good, have packaging with pictures of cute animals and fruit, and advertisements portray doctors touting the products, which range from pills and syrups to rubs and nasal sprays, advocates told the FDA.

The industry already said it would remove claims that its products are “pediatrician recommended” from packages and advertisements, CHPA’s Suydam said. “I don’t think simply marketing them encourages parents to use them,” she added.

The FDA had said it planned to issue an opinion on children ages 2 to 6 earlier this year, but in August asked for more information and announced a public meeting.

John Jenkins, director of the FDA’s Office of New Drugs, said the agency will propose changing its rules, which could take months, up to a year or longer with a change in presidential administrations coming in January.

New rules could further restrict use of the products in children, a process that could take years, or require them to go through a new approval process requiring clinical trials. In the meantime, the agency may issue further advice to parents after it weighs information from the meeting, Jenkins said.

Until then, parents of children older than two “should carefully follow the directions on the labeling,” measure the proper dose and keep the products out of children’s reach, Jenkins told reporters.

But doctors and advocates said the agency already knows the drugs have never been proven and has had years to act.

“It’s a problem of lack of will,” Diana Zuckerman, president of the National Research Center for Women & Families, said in prepared comments for the agency.

Editing by Andre Grenon, Richard Chang

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