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."
