WASHINGTON -- The government issued its strongest warning yesterday about the dangers of cough and cold medicines for infants, urging parents to stop giving the over-the-counter remedies to children 2 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 on dangerous or fatal side effects. 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 before the major makers of over-the-counter cold medicines voluntarily withdrew some infant products in October. Ganley said it appears that 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 such as Dimetapp, Triaminic and Robitussin - have been staples of child medicine since the early 1970s. Pharmaceutical companies aimed some products directly for 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 firm. But there was little evidence the medicines work safely, just the assumption that they would because of their benefits to adults.
In fact, professional groups such as the American Academy of Pediatrics warned for years against using the medicines 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 City's health commissioner, and other pediatricians found the products led to some deaths - four in Baltimore from 1999 to 2005. The pediatricians asked the FDA to ban marketing the medicines for children 6 and younger.
Sharfstein urged the FDA yesterday to warn about the dangers for kids 2 to 6 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 substitute remedies: treating with saline nose drops, giving children soup and other warm liquids, and running a humidifier.
Parents should call pediatricians, he said, if their child experiences shortness of breath, coughs for more than a week, has a lot of mucus or is listless.