FDA Panel Weighs Ban on Kids' Cold Medicines

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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."

In a statement summarizing the group's expected testimony before the FDA committee on Friday, the CHPA defended both the safety and the effectiveness of over-the-counter children's cold medications.

"Both placebo-controlled and active comparator studies (eight in total) show these medicines are effective in reducing cough and cold symptoms in children," the CHPA stated. In addition, "in a recent national survey, 91 percent of parents using these products reported that these medications made them or their child feel more comfortable, and 89 percent of parents said OTC cough medicines helped their child cough less."

As for child safety, the CHPA said that "serious adverse events associated with over-the-counter cough and cold medicines are very rare," and are almost always caused by overdose, "which underscores the need for proper storage and safekeeping of these medicines."