Manufacturers of pediatric cough
and cold medicines announced Tuesday that they would voluntarily change their products’ labels to say that they should not be used in children under age 4.
In addition, products with certain antihistamines will get new language warning parents not to use them to sedate or make a child sleepy. While many parents believe that getting a sick child to sleep is the best medicine, the use of sedatives
is widely discouraged by medical experts, who say they can worsen breathing problems caused by illness.
“We’re trying to prevent as many medication errors as we can, and we think this is the right direction,” said Linda A. Suydam, president of the Consumer Healthcare Products Association, a trade organization that represents the makers of over-the-counter medicines.
Officials at the Food and Drug Administration
said they supported the changes, but promised to continue a long process to reassess the safety and effectiveness of the products in children of all ages.
The government is hoping the new labels strike a balance between two competing concerns: that the drugs may not be safe in young children, but that some parents may give their children adult medicines if the agency bans pediatric products.
Warning against the drugs’ use in children under 4 “seemed like a logical place where it took into account the need to have dosing instructions in children but also a clear message for parents of very young children” not to use the products, said Dr. Janet Woodcock, director of the F.D.A.’s drug center.
Safety experts at the agency recommended a year ago that it consider banning use of over-the-counter cough and cold medicines in children under 6, and an advisory panel concurred. Manufacturers agreed at first only to warn against the products’ use in children under 2 and vowed to fight further restrictions.
Last week the F.D.A.’s science panel took testimony on the issue, with some experts urging greater restrictions. Tuesday’s action by the drug makers, their second set of concessions over the question in the last two cold seasons, arose from continuing discussions with the agency.
About 39 percent of households use pediatric cough and cold products — about 95 million packages a year. Eight hundred of these products are sold in the United States, and each contains one or more of 39 drugs.
Despite the products’ extraordinary popularity, every study performed in recent years shows that they have no therapeutic effect beyond sedation, and a growing number of reports have concluded that they can be dangerous. The risks are as varied as hives
, neurological problems and, in rare cases, even death.
Many injuries from pediatric cough and cold medicines occur when young children get their hands on medicine bottles without their parents’ knowledge. But accidental overdoses have also resulted when parents confuse dosing instructions or give their children two products without realizing that those drugs share ingredients.
Ms. Suydam said that most of the pediatric injuries occurred among children under 4 and that banning the drugs’ use in that age range should therefore solve a vast majority of problems.
Dr. Dianne Murphy, director of the drug agency’s Office of Pediatric Therapeutics, said the agency hoped to get far better data on the medicines’ safety. “In the meantime,” she said, “we are basing our decision on where we think the highest risk is.”
Diana Zuckerman, president of the National Research Center for Women and Families, said the products should not be used in children under 6. “No risk is acceptable for products with no benefits,” Dr. Zuckerman said. “Families are being ripped off, and children are being harmed.”