THURSDAY, Oct. 18 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Thursday began two days of hearings to consider banning the sale of over-the-counter cough and cold medicines for young children.
Such a ban already has the support of safety experts at the FDA, who published a 365-page review last month that showed decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.
Many outside experts are also in favor of restricting children's access to cold remedies.
"The panel should recommend that the FDA carefully reevaluate their existing approval of cough and cold preparations being marketed to children under 6," said Dr. Michael Shannon, chief of the Division of Emergency Medicine at Children's Hospital Boston. "Our hope is that they will agree that it is not appropriate to market these products to children."
But on the first day of the hearings, some advisory panel members questioned the idea of a ban, according to the New York Times.
"If these medicines are allegedly not effective or materially unsafe, how is the purchase of hundreds of millions of doses by parents to be explained?" asked Dr. George Goldstein, a pharmaceutical industry consultant who is a nonvoting member of the panel. "I don't believe the American caregiver or parent is, in a word, stupid."
Panel chairwoman Dr. Mary E. Tinetti, who is a professor at Yale University, said that many parents must think the drugs work and "are voting with their feet, so to speak."
She added that the number of children who are reported to have died after taking these medicines seemed relatively small compared to the millions given the drugs.
The products covered in the debate include approximately 800 popular medicines sold in the United States under names such as Toddler's Dimetapp, Triaminic Infant and Little Colds. Experts estimate that Americans spend about $2 billion annually on these types of medications.
Last Thursday, leading drug makers announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants.
That move affected only infant oral medicines, not those intended and labeled for use in children aged 2 and older, Shannon noted.
Shannon, who filed the original petition with the FDA in March and is testifying at the hearings, doesn't think that last week's recall by manufacturers goes far enough. It only affects children under 2 and not children between 2 and 5, who make up two-thirds of those taking the drugs, he noted.
"They made an effort, but it was nowhere near far enough," Shannon said.
In addition, these cold products simply don't work, according to Shannon. "There is no reason to give something that costs money, is ineffective, and has potential risks," he said.
"One can question what their effectiveness is in older children and even adults," Shannon said. "Across all ages, the scientific evidence for their effectiveness is very weak and, for children under 6, the data are clear that they don't work."
Linda A. Suydam is president of the Consumer Healthcare Products Association (CHPA), which represents manufacturers of nonprescription medicines. In a statement, she said that, "The reason the makers of over-the-counter oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."