Even though the chance of a child, age two to six, suffering a serious adverse event from ingesting one of the many over-the-counter (OTC) pediatric formulations of cough and cold medicines is only about one in 20 million doses, there is little evidence that says these drugs actually work as expected, according to a strong list of drug company officials, physicians, children’s safety and health advocates, medical experts, and federal officials. In spite of the lack of proof that these OTC drugs work in children as in the adults who tested the medications, Americans spend about $300 million on them every year.

At least one-third of all American households are thought to buy OTC children’s cough and cold remedies, with about 10% of the nation’s children medicated by these drugs at any given time. In spite of their popularity, a group of doctors led Monday’s call to the US Food and Drug Administration (FDA) asking for a nationwide ban against treating children under the age of six with these drugs. The request was denied, although a previously issued health advisory warning against giving these medications to children younger than two still stands.

When the FDA rejected the request to ban using these drugs on children younger than six, some of the pharmaceutical companies making these OTC pediatric drugs voluntarily issued an advisory to parents asking them to not use these drugs on children younger than four years old. The move is supported by the American Academy of Pediatrics, which backs the ban on the medications for children under six years of age because the effectiveness of these medications has not been studied in children and the risks seem to outweigh the benefits, based on current scientific evidence.

The Consumer Healthcare Products Association, the industry trade group representing the cold-medicine industry, says these products are both safe and effective when used properly.

The results of a study recently released by the US Centers for Disease Control and Prevention (CDC) implicate OTC children’s cough and cold remedies as the reason behind roughly 7,000 emergency room (ER) visits involving children under the age of 12. About two-thirds of these cases involved overdoses, some of which occurred when children were left unattended by an adult and took these drugs themselves. Most involved in these ER visits are the children aged two to five years old.

Recently released data from Arizona revealed OTC cold medicines were associated with 10 “unexpected” infant deaths in that state in 2006.

Source: Washington Post