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 was 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."
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