FDA advisers frown on cold medicine for kids

FDA experts do not support use of cold medicine in kids under 6; drugmakers' bottom line unlikely to feel pain if drugs get nixed.

By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- In a panel meeting on Friday FDA advisers decided that children under the age of 6 should not be using cold and cough medicines because they have not been proven to be effective or safe.

Experts for the Food and Drug Administration voted 13-9 that cold medicine should not be used by children under 6. This non-binding vote is to be taken into consideration by FDA regulators, who might take action against the products at a later time.

The vote applies directly to the companies Johnson & Johnson (Charts, Fortune 500), Wyeth (Charts, Fortune 500) and Novartis (Charts), which all make cold medicine for kids. But even if the panel vote does result in regulatory action, it won't take much of a bite out of Big Pharma's balance sheet because childrens' cold medicines make up just a sliver of their overall sales.

The drugmakers don't break out sales figures for specific over-the-counter products, so the exact impact of regulatory action would be difficult to quantify. But Wyeth spokesman Douglas Petkes said that over-the-counter drugs, including cold medicines Robitussin and Dimetapp, make up just one-tenth of company sales, which totaled $16.6 billion in the first nine months of 2007. Furthermore, Petkes said that only 20 percent of those OTC sales go to children under the age of 6.

"I'll let the numbers speak for themselves," said Petkes.

Likewise, Michael Krensavage, analyst for Raymond James & Associates, said the impact on cold medicine maker Johnson & Johnson would be "insignificant."

Still, use of these drugs is widespread. A study from the Journal of the American Medical Association, released in 1994, found that more than 35 percent of all kids used cold medicine in a specific 30-day span, according to the FDA.

Drugmakers say their cold medicines are safe and effective for kids at the recommended levels. "Given the extensive use of these medicines, serious adverse events in children of all ages are extremely rare," said the Consumer Healthcare Products Association, the industry group representing makers of OTC drugs, in documents on the FDA's Web site.

Pediatricians and drugmakers all seem to agree on one thing: that serious side effects, such as fatalities, are quite rare. But some pediatricians believe that children should not be using these products at all, given the difficulty that parents have in giving children the proper dosage, resulting in side effects, such as drowsiness.

"I think they are neither safe nor effective," said Dr. Michael Shannon, pediatrician with Children's Hospital Boston and professor of pediatrics at Harvard Medical.

Shannon was one of the petitioners who brought this topic before the FDA for open discussion and said he was "overjoyed" by the panel vote. Shannon addressed the panel at its Thursday meeting in Silver Spring, Md., saying that of the more than 500 million doses administered annually, the two primary problems are overdosing and mixing different medications.

"The problem is the risk-benefit ratio," he said. "These drugs are not effective. They do not work to relieve the symptoms of a cold."

The majority of side effects tied to overdoses are minor, such as irritability in young children, according to Dr. Kim Giuliano, general pediatrician with the Cleveland Clinic.

"They can start crying uncontrollably," said Giuliano, adding that many parents make the mistake of using tablespoons instead of teaspoons in measuring out doses.

Dr. Daniel Rausch, director of the pediatric hospitalist program for New York University, said that cold medicine is only effective at doses that are too strong for young children.

Rausch recommends a more traditional treatment where dosing isn't a problem: chicken soup.

"A cold does not kill, so people should just relax," said Rausch. "Kids get sick and there's nothing that people can do about it, but they will get better." Top of page