The makers of cold and cough medicines said yesterday that they will stop marketing over-the-counter remedies to children under 4 - acting amid an extensive federal review of whether the drugs are safe and effective for children under 12.
The voluntary decision comes two years after Baltimore Health Commissioner Dr. Joshua M. Sharfstein and a group of leading pediatricians petitioned the U.S. Food and Drug Administration to stop the sale of the medicines to young children, saying the products are not effective and could cause harm.
Yesterday, the president of the group representing the makers of the products maintained that the medicines are safe and said the industry is making the change "out of an abundance of caution and in an effort to promote the safe and appropriate use of these medications."
"Adverse events are very rare," said Linda Suydam, president of the Consumer Healthcare Products Association.
When children have been harmed, she said, it has usually involved accidental overdoses by 2- or 3-year-olds. Adults may give them too much, she said, or unsupervised children drink the syrups.
Popular syrups from such brands as Triaminic and Robitussin with labels saying "Do Not Use" for children under 4 are being shipped to stores now, she said.
Older packages - minus the warning - are likely to remain on store shelves for several months during the transition, Suydam said.
In an interview, Sharfstein called the decision a "big step forward for the health of children," but he reiterated his belief that the products should not be used for children under 6.
"There really is no data to support that these products work at all in kids," he said. "And it causes risks."
Toddlers, Sharfstein and industry representatives agree, are at highest risk of having a bad outcome from taking the medicines.
"That group is the ones who grab it and drink it when the parents aren't looking," Sharfstein said. "The smaller the child, the more the chance for adverse events."
He and others in Maryland launched their campaign after the medications were linked to the deaths of four Baltimore children under the age of 4.
Last fall, a federal advisory panel recommended that the remedies not be given to children under 6 and found no evidence that they are effective in children under 12.
In January, the FDA issued a public health advisory urging parents to stop giving them to children under 2, warning of "serious and potentially life-threatening side effects."
Last month, the FDA announced a broad review of its regulations, a yearslong process that began with public hearings last week. That will continue despite the industry's decision yesterday, officials said.
"This voluntary move by the industry in no way supercedes addressing the entire age range," said Dr. John Jenkins, director of the FDA office of new drugs.
The medications were not tested on children when they came on the market in the 1970s - an era in which pediatric clinical trials were frowned upon. Today, pediatric research has evolved and a core element of the FDA's review includes analyzing new research to determine the drugs' efficacy and safety, said Dr. Janet Woodcock, director of the FDA's center for drug evaluation and research.
While the FDA called the industry's decision "voluntary," officials acknowledged that they have talked about the possibility with drugmakers for months.
"We certainly had discussions about changing the labels because we recognize that the rule-making can take many years, at best," Woodcock said.
About 95 million packages of pediatric cough and cold medicines are sold in a given year in the United States, with an estimated 39 percent of households buying the products, according to the industry.
Still, the change to labels is unlikely to hurt the pharmaceutical giants who make them, such as Johnson & Johnson and Wyeth, said Linda Bannister, senior health care analyst with Edward Jones in St. Louis.
For instance, Johnson & Johnson, whose diverse array of products includes medical devices, brand name pharmaceuticals and baby shampoo, earned $61 billion in 2007. Cold and cough remedies accounted for just a slice, she said.
"These are such a small part of their business that we don't expect it to have a significant impact from a financial perspective," she said. "From the companies' perspective, safety is very important. You'd rather give up a little revenue to ensure the safety of their patients."
The industry has launched clinical trials and a public education campaign warning parents to store the medicines out of children's reach and to give the proper dose.
Woodcock said studies show that parents sometimes give children adult doses, even with current warnings.
Some medical experts maintain the remedies are inherently unsafe.
Dr. Daniel Levy, past president of the Maryland chapter of the American Academy of Pediatrics, said he thinks yesterday's decision will lead to an eventual ban of the products for all children.
"It's one the best things I've done in my career," he said of his role in the campaign. "Thirty years ago when I was in training, we were taught not to use those medicines because they didn't work, and there was evidence of it then."
The Owings Mills pediatrician said the medicines can actually delay recovery because many contain antihistamines, which can dry out the bodily defenses that help fight off a cold.
"Frequently, this time of year, I'll see many kids come in, but they should have come in days earlier," he said. "But a parent gave them cold medicine, so they come in with more serious problems such as pneumonia."
Rather than turning to cold products, he said, adults should take a minimalist approach: run a humidifier in the child's room, use salt water nose drops and give plenty of fluids.
Said Levy: "If there is any risk involved for medications that don't work in the first place, why bother using them?"