Over-the-counter cold medicines should not be given to children under six years old, an advisory panel recommended to the U.S. Food and Drug Administration Friday.
In two separate votes, the panellists decided the medicines shouldn't be used in children younger than two, nor in those younger than six. A third vote that would have recommended against use in children between 6 and 11 years old failed.
The recommendations come as the panel winds down two days of meeting on the safety of over-the- medicines designed for infants and children that contain decongestants, expectorants, antihistamines and cough suppressants.
The FDA isn't required to follow the recommendations of its advisory panels, but almost always does.
It's not clear what effect any FDA decision would have on Canadian sales of the products. Health Canada says it too is reviewing children's cold medications and is watching the panel's proceedings.
"Health Canada will consider the results of this meeting as we move forward with our review and recommendations regarding these products," the agency said in a statement.
Many U.S. pediatricians have been lobbying for restrictions on the sales of non-prescription cold medicines for many years, noting there have been too many incidents of overdose, leading to hospitalizations and even deaths.
On the one side of the debate have been those who say that not only is there no evidence the medicines relieve cold symptoms in kids, the products are dangerous.
On the other side have been the medication manufacturers who say the medicines are effective and safe for kids when given as directed. They have said they were willing to change labeling instructions to remind parents about the risk of overdose but want sales of the drugs to continue.
Last week, in a pre-emptive move, most manufacturers decided to voluntarily pull their cold medications designed for children under 2, sold under such names as Dimetapp Oral Infant Cold Drops and Benylin for Infants Cough and Cold Drops.
In Canada, the Nonprescription Drug Manufacturers Association of Can (NDMAC) said the withdrawal was "a highly cautionary response to rare patterns of misuse identified during the course of a review of safety data related to children's cough and cold medicines."
In cases of overdoses, either too much medication was given, it was given too often, or more than one cough and cold medicine containing the same active ingredient were used.
Earlier Friday, the panel called on drug manufacturers to conduct studies on children to prove that over-the-counter cough and cold medicines are effective in those younger than 12, noting that many of the drugs currently for sale have never been tested in children.
The FDA has generally not required companies to prove the medicines work in children; instead, data has been extrapolated from studies conducted on adults.
An FDA review found just 11 studies of children published over the last half-century. Twenty-one of the advisory panel's experts decided in a vote Friday that it's not appropriate to extrapolate the results of adult studies to children between two and 12 since their metabolisms can differ.
Pediatricians calling for tighter restrictions told the panel Thursday that some studies have suggested the medicines are no better than placebo pills in treating cold and cough symptoms in young children.
"When a treatment is ineffective, its risks -- if not zero -- always will exceed its benefits," said Dr. Michael Shannon, a Children's Hospital Boston pediatrician and Harvard Medical School professor who was another of the petitioners.
But some panelists seemed reluctant to believe the claim that the medicines don't work.
"If these medicines are allegedly not effective or materially unsafe, how is the purchase of millions -- hundreds of millions -- of doses by parents explained?" asked Dr. George Goldstein, a member of the advisory panel who is representing the drug manufacturing industry.
