Docs Support FDA Cough Medicine Warning

Aug. 16, 2007 — -- Every parent in the country is likely familiar with over-the-counter cold medicines -- and even comfortable reaching for them when their children are ill.

But a public health advisory issued by federal health officials Wednesday may change the way many parents view cough and cold preparations intended for their children's relief. The FDA said that children under 2 shouldn't be given these remedies without a doctor's order because of serious adverse effects, including death.

Dr. Janet Serwint, associate professor of pediatrics at Johns Hopkins Children's Center in Baltimore, Md., said her past experiences certainly raise a red flag -- especially considering the dosing errors that send many children each year to hospitals for medical treatment.

"I've been involved with cases in which the parent and the grandparent both gave the child the preparation without knowing it, and were not worried because it is over-the-counter," she said. "I have been in situations where parents gave more and more doses because they assumed it was safe."

The advisory comes two months ahead of a scheduled FDA Nonprescription Drugs Advisory Committee meeting on Oct. 18-19 to discuss the use of the drugs by children -- a meeting spurred by a petition in March by a group of doctors, including Serwint.

Concern may well be warranted. In January, a study conducted by the Centers for Disease Control and Prevention (CDC) showed that in 2004 and 2005, more than 1,500 children under the age of 2 had to be taken to an emergency department due to serious health problems after taking these common remedies. Three of these children died.

Other reports have suggested that young children up to the age of 6 may be at risk of life-threatening adverse effects from the medications.

The findings have prompted some doctors to worry that parents who give these products to their children may be putting them at risk for hallucinations, seizures and potentially fatal heart problems -- all in exchange for little, if any, real benefit.

The medicines have since come under harsh scrutiny from at least one professional organization; last year, the American College of Chest Physicians recommended that parents avoid giving cough and cold medicines to their children, particularly younger children.

Industry representatives continue to stand by the safety and efficacy of the products, however. In a statement issued Thursday, Linda Suydam, president of the trade association Consumer Healthcare Products Association (CHPA), which represents U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products, defended the remedies.

"Millions of Americans safely and effectively use OTC cough and cold medicines every year, both for themselves and for their families," according to the statement. "These medicines have been found safe and effective by the U.S. Food and Drug Administration (FDA) and are the same medications families have trusted for decades to help relieve cough and cold symptoms and make their children feel better."

But Dr. Joshua Sharfstein, commissioner of the Baltimore City Health Department, called this assertion "completely untrue."

"There products have not been evaluated for safety in children," he said. "They kind of snuck in through an evaluatory back door."

Cough medicines are one of a number of products whose safety profiles have been tested on adults, but not on children -- a concern reiterated in March by Dr. Charles Ganley, director of the FDA's office of nonprescription drug products.

Sharfstein was also part of the group of doctors that petitioned the FDA to review the products on the grounds that they haven't been specifically evaluated for safety and effectiveness in this age group.

"What we're asking is for these products to be held to a reasonable standard of safety and efficacy [for children]," he said. "To the extent that there is evidence in kids, the evidence is that they don't work."

Pediatricians Urge Caution

The warnings about cough and cold remedies are being echoed by many pediatricians, who note that parents may not be aware of possible adverse effects.

"In proper doses it is not dangerous, but some parents don't know what proper doses are," Dr. Lisa Thornton, a pediatrician at Children's Hospital in Chicago told ABC News medical editor Dr. Tim Johnson on ABC News Now's "Healthy Life" program Thursday.

Part of the confusion over dosing, she said, has to do with the fact that the amount of the drugs taken by the child should be measured according to the child's weight rather than their age, since children of the same age can vary drastically in terms of weight.

However, current dosing recommendations for the product are, in fact, based on a child's age.

"What we discuss with parents is that these medicines do have dangerous side effects, even though they are sold over-the-counter," Thornton said. "Pediatricians need to stress to parents that these are medicines that are not without side effects."

Alternatives to the Bottle and Spoon

Thornton noted that there are several drug-free ways to sooth a child's cough.

Parents may want to place a vaporizer in the child's room, or have the child take a hot shower, as the steam may soothe their throats and sinuses. Even spending time with a child as they fall asleep can often help relax children when they are uncomfortable.

And as for the medicines, it is still unclear whether the Oct. 18-19 meeting will yield new regulations. However, Sharfstein said he is optimistic.

"I think it is very encouraging that this is going before an advisory committee," he said. "It's a mechanism for the FDA to really shift tracks on how it's treated these products."