The meeting of its Nonprescription Drugs Advisory Committee next month comes in the wake of recent concerns about their use, especially in children below the age of two.
Part of the review is expected to cover reports of medical problems arising from incorrect use of cough and cold drugs for children, and most importantly, overdoses. For example, in some cases parents have not realized that different products may contain the same active ingredient and giving a child both at the same time results in a combined dosage that exceeds the safety level.
The debate over the issue has risen primarily because standards for drug approval have tightened in the last few decades. Besides, some children's medicines were approved when standards were not so tight as they are now. According to the New York Times, in some cases the drugs were only tested on adults and it was assumed they would be safe for children.
Says a report in the New York Times: "If those drugs were currently up for review, they would not be approved for use in children because the manufacturers never tested them thoroughly in children."
Dr. Janet Serwint, associate professor of pediatrics at Johns Hopkins Children's Center in Baltimore, Md., says her past experiences certainly raise a red flag - especially considering the dosing errors that send many children each year to hospitals for medical treatment.
Says Serwint: "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.
"I have been in situations where parents gave more and more doses because they assumed it was safe", she adds.
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.
Doctors stress that parents should be made aware of these facts:
· Children get better with time, and cough and cold medicines only treat symptoms like runny noses, congestion, aches and fever, they don't cure colds.
· Giving children, especially those under 2, too much medicine can lead to serious life-threatening side effects.
· Never give cough and cold medicines to children under 2 unless a doctor has specifically directed it.
· Never give children cough and cold remedies packaged for adults; only give those indicated specifically for babies, infants, children or "pediatric" use.