Sick daze

Are cough-and-cold remedies so essential to getting children through winter that it’s impossible to imagine life without them? Is a mother’s drive to relieve the symptoms of her coughing, runny-nosed toddler so great that doing nothing isn’t an option? Are the sweet, colored liquids such a part of the American response to illness that we can’t let them topple onto the ash heap of history?

Those questions were on the minds of policymakers at the Food and Drug Administration recently at a hearing to discuss whether to limit use of nonprescription cough-and-cold preparations in children.

Despite their ubiquity on drugstore shelves and in household medicine cabinets, these medicines occupy a kind of dead zone in pharmaceutical knowledge. Here’s the problem: Very little is known in a formal scientific sense about how safe and effective they are and, if they are, about how to calculate the right dose across the ages and sizes of childhood.

One of the few things that is known is that parents trust these remedies and give them to their children frequently.

According to data provided by the Consumer Healthcare Products Association, “approximately 95 million packages of oral pediatric cough and cold medicines are sold in a given year. An estimated 39 percent of households purchased these products.”

A study published in the journal Pediatrics in August reported that in any given week from 1999 to 2006, 10.1 percent of American children were taking the medicines. The 2-to-5-year-old age group had the greatest exposure. Pediatricians recommend the remedies 20,000 times a week for children ages 2 to 6 and 13,000 times a week for children 6 to 12, a CHPA representative said at the hearing.

The FDA’s specific task is to rewrite the remedies’ “monograph,” the official description of how they should be used. When the document was first written in the 1970s, proof of the remedies’ effectiveness in children wasn’t required. Instead, it was extrapolated from studies in adults.

About 95 percent of the cough-and-cold remedies sold over the counter contain one of eight compounds (and often several together). They include antihistamines, which dry the moist membranes of the nose and mouth, and cause sedation in the brain; compounds with mild amphetamine-like effects, which “decongest” nasal passages; dextromethorphan, a relative of opiates that suppresses coughing; and guaifenesin, which thins mucus.

The hazard from use of the drugs is uncertain, but it appears to be very small. In February 2007, the FDA reviewed data on serious and life-threatening side effects, and death, in children younger than 6. From 1969 through fall 2006, there were 123 deaths: 54 from decongestants and 69 from antihistamines, the majority in children younger than 2.

CHPA officials say that serious “adverse events” from use of the drugs in 2 to 6 year olds occur about once in every 20 million doses. (This excludes accidental overdoses.)

Two months ago, researchers in Arizona reported that 10 “unexpected” infant deaths in that state in 2006 were associated with over-the-counter cold medicines.

A year ago, makers of the remedies stopped marketing them for use in children younger than 2. The packaging had advised parents to “consult your physician” in giving the drugs to children that young.

Now, a group of physicians led by Joshua M. Sharfstein, Baltimore’s health commissioner (and a pediatrician), is asking the FDA to request that the companies stop marketing them to children younger than 6. They argue that no risk is acceptable because there has been no convincing evidence of the remedies’ effectiveness.

The manufacturers are trying to prove they work.

“We are pulling together the scientific data to reaffirm the efficacy of these products,” said Linda Suydam, CHPA’s president. “We know they’re safe and effective because we have adult data.”

Several experts said, however, it may be extremely difficult to prove the remedies relieve symptoms in children too young to describe their sensations in detail.

Hovering over the issue is the question: What would happen if the pediatric formulations of the medicines were pulled off the shelf? Would parents, faced with sleepless and symptomatic toddlers, reach for the adult formulation and pour out a guessed-at dose. “That is a concern for us,” John K. Jenkins, the physician who directs the FDA’s Office of New Drugs, said Thursday at a break during a day-long hearing on the drugs’ use in children. “We do not want to do something … only to have unintended negative consequences. We could have an even worse situation.”

Several pediatricians, from both medical school and community practices, spoke at the hearing on behalf of the CHPA. They said that without pediatric formulations of the drugs, parents might turn to more dangerous alternatives, including herbal products. Several feared the risk might be greatest in low-income or single-parent households, where staying home with a sick child is an especial hardship.

Sharfstein and several other pediatricians, including a representative of the American Academy of Pediatrics, said that parents will listen to advice. Several cited the huge drop in use of aspirin in children two decades ago after parents were warned it could cause the rare, often fatal Reye’s syndrome.

Sharfstein told the FDA officials that calls to the Maryland Poison Center about children younger than 2 who had taken cough-and-cold remedies declined 40 percent in the first six months of this year compared with last. He said this was evidence that parents were following the advice to not give the medicines to children that young.

He acknowledged that the FDA would have a lot of consciousness-raising to do. But he said that shouldn’t stop the agency.

“The marketing frankly preys on the guilt of the family – ‘This is something you should be doing for your kid. This makes you breathe easier, too,’ ” Sharfstein said.

“But you would have the pediatricians and the nurse practitioners standing with you,” he added. “You have more authority than you realize to get parents to pay attention to the message you want.”