FDA to parents: Stop giving infants cold medicine

WASHINGTON -- The government issued its strongest warning Thursday about the dangers of giving cough and cold medicines to infants, urging parents to stop giving the over-the-counter remedies to children two and younger.

The Food and Drug Administration released the warning out of fear that many parents have continued treating sick infants with popular pediatric cold products despite a flurry of recent reports highlighting the dangerous side effects, including death.

Recent surveys showed that a majority of parents still think it's OK to give the medicines to young children without consulting a doctor.

"The purpose of this is to get the message out to parents," said Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products.

The danger isn't as great as it was a few months ago, before the major makers of over-the-counter cold medicines voluntarily withdrew some infant products in October. Ganley said it seemed stores -- in the Washington area at least -- have removed the products from shelves. But he couldn't be sure that was the case elsewhere.

The syrups and drops -- from respected brands like Dimetapp, Triaminic and Robitussin -- have been staples of child medicine cabinets since the early 1970s.

Pharmaceutical companies aimed many of the products directly at use in kids, putting "Infant" in the names or images of young children on boxes.

The products generated $430 million in yearly sales, according to Packaged Facts, a market research company. But there was little evidence the medicines work safely, just the assumption they would because of their benefits to adults. In fact, professional groups like the American Academy of Pediatrics warned for years against the medicines' use for young children.

As it turned out, children don't necessarily react the same as adults to medicines. Last year, Dr. Joshua M. Sharfstein, Baltimore's health commissioner, and other pediatricians found the products led to some deaths. The pediatricians asked the FDA to ban the marketing of the medicines for children six years and younger.

Sharfstein Thursday urged the FDA to warn about the dangers for children two to six years: "Every day the FDA doesn't make the statement for older kids is another day companies are marketing the products to older kids, so there's some urgency."

FDA staff and advisers have recommended banning over-the-counter cough and cold medicines for children under 6. Agency officials said they were trying to resolve some disagreements about the appropriate response, but hoped to take action soon. In the meantime, they urged caution, such as making sure kids aren't getting the same ingredients in different medicines.

Dr. Jay J. Gopal, chief of pediatrics at Union Memorial Hospital in Baltimore, said he has counseled parents about the hazards for young children since the publicity started. He suggests parents turn to substitute remedies: treating with saline nose drops, giving children soup and other warm liquids, and running a humidifier. Parents should call pediatricians if their child experiences shortness of breath, coughs for more than a week, has a lot of mucus or is listless.