Back to School


FDA Unsure on Cold Medicine for Small Children

October 03, 2008 05:14 PM
by Anne Szustek
The FDA is hesitant to institute a ban on cold medication for young children. Yet some pediatricians say that cold medications for young children do more harm than good.

Ban on Kids’ Cough Medicine May Have ‘Unintended Negatives’

The U.S. Food and Drug Administration held a public hearing Thursday on potential risks of over-the-counter (OTC) cold medications for children age 2–6. The initial verdict is that the federal regulatory body says more research is needed before it can institute a ban.

One key concern of the FDA’s is that if such a ban were put in place, parents would resort to giving adult cold medicines to their young children.  Dr. John Jenkins, the head of the FDA’s Office of New Drugs, was quoted as saying by the Associated Press, “We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation.”

Drug manufacturers have already pulled OTC cough and cold medicines intended for children age 2 and under. A statement given by the Consumer Healthcare Products Association yesterday said that it would conduct a “multiyear plan” to look into the possible risks for cold medicines given to children between the ages of 2 and 12.

According to statistics cited by the AP, some 7,000 children went to the emergency room last year for complications related to cold medicines. Much of the risk comes from inadvertent overdoses.

When the FDA established safety criteria for cough and cold medicines about three decades ago, no specific pediatric studies were undertaken. Pediatricians have thus long weighed the merits of giving OTC cold medications to young children vis-à-vis the risks involved with potential side effects, and an FDA advisory panel pushed the regulator to recommend that they not be administered to anyone under the age of 6.

“When a treatment is ineffective, its risks—unless zero—always exceed its benefits,” Children’s Hospital in Boston’s Dr. Michael Shannon was quoted as telling the FDA panel.

Background: Cold medicine alternatives; risks of children taking adult cold medicines

Doctors have long prescribed fluids and rest as the best way to fight off a cold. The American Academy of Pediatrics suggests that anyone older than an infant can safely get cold relief from a spoonful of honey, and a humidifier in children’s bedrooms can help clear sinus congestion. Plus humidity can help sustain warmer ambient temperatures, which can help to shorten the life of flu viruses, as suggested by studies released last year by researchers in New York.

Another tried-and true home remedy, chicken soup, may also have anti-inflammatory properties superior to those of herbal supplements thanks to antioxidants in its ingredients, according to a study released last year by Nebraska Medical Center.

As for giving children medication intended for adults, much of the risk lies in the fact that they were not tested for safety in children. “At times, children have been harmed and maybe even killed because of a lack of knowledge of how drugs would affect them,” Dr. Robert M. Ward was quoted by the FDA in a 1999 paper. He points to the deaths of several newborns in the 1960s after they were given chloramphenicol, an antibiotic that could not be broken down by infants’ livers.

Most Recent Beyond The Headlines