A Cold Winter for Kids' Drugs

Recent FDA statements, an impending meeting, and pharmaceutical recalls add up to a chilly forecast for infants and children's cough and cold medicines

by Zoe Galland

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As flu season kicks in with the full force of winter, parents looking for cold medicines for sick infants won't find the usual selection in pharmacies. For children over 2, parents can still find an assortment of cough and cold medicines in stores, but these products may soon be gone as well.

The Food & Drug Administration will soon meet to discuss the safety and effectiveness of cold medicines for children under the age of 6. Children's cough and cold medicines have been sold over-the-counter in the U.S. for more than 40 years, but recent actions by an FDA advisory committee and pharmaceutical manufacturers have raised the issue of whether children's cough and cold medications are not only potentially dangerous because of possible misuse, but also ineffective. Rita Chappelle, a spokeswoman for the FDA, declined to give an exact date when the FDA will meet to discuss the children's medicines, saying only that it would happen in the next "couple of weeks."

Several pharmaceutical manufacturers have voluntarily recalled infant cold, cough, and congestion medicines, citing the dangers of overdosing. For now, the withdrawals apply only to medicines for children under the age of 2.

If the FDA takes an action such as restricting the marketing of children's cough medicines, pharmaceutical companies will be the ones catching cold. They're already facing lawsuits, which are likely to increase should the FDA rule against these medicines, not to mention the substantial revenue at risk. The Consumer Healthcare Products Assn., a group that represents leading manufacturers and distributors of over-the-counter medicines, estimates that 95 million packages of cough and cold medicine, for a total of $311 million, are sold in the U.S. each year. The research firm AC Nielsen reports that sales of cold and cough medicine for children under 6 rose 20% from 2006 to 2007.

Statements and Recalls

The FDA jump-started the debate in August, when it released a public health advisory notice that the Nonprescription Drugs Advisory Committee (NDAC), a panel of government advisers, would meet in October to review cough and cold products' effects on children. When it met on Oct. 17, the committee concluded that parents should not give the products to children under 6.

Five days earlier, Johnson & Johnson (JNJ), Wyeth (WYE), and Novartis (NVS) had voluntarily recalled 14 oral infant cold, cough, and congestion medicines. None of the companies mentioned the FDA in their statements about the recalls. J&J, which pulled seven products, including Concentrated Tylenol Infants' Drops Plus Cold and PediaCare Infant Dropper Decongestant, issued its statement on Tylenol's Web site: "We have become aware of rare instances of misuse leading to accidental overdose, especially in children under the age of two," it read. "Therefore, we are voluntarily withdrawing the following concentrated cough and cold medicines from the market."

FDA spokeswoman Chappelle says the voluntary recalls were not at the FDA's request: "They did that on their own, going into our advisory committee meeting."

After its meeting, the NDAC stated that children's cough and cold medications are not only potentially dangerous because of possible misuse, but are also ineffective. One member of the committee, Sean Hennessey, of the University of Pennsylvania School of Medicine, said there was "no evidence of efficacy of the drugs."

The Possibility of Death

What makes the medicines risky enough to spur voluntary recalls and an FDA committee meeting? One of the key ingredients in cough and cold medicines for infants and children under 6 is dextromethorphan, a cough suppressant. When incorrectly measured, it has a number of side effects, especially in children.

Pediatrician Giuseppe Dellorusso, who has practiced medicine in East Rockaway, N.Y., for 16 years, says he never recommends children's cold and cough medicines. "They speed up the heart rate and cause excessive irritatibility," he says. "There are all kinds of side effects that are well documented. And parents do overuse them; they go above the recommended dosage."