Tuesday Oct. 7, 2008 (foodconsumer.org) -- The manufacturers of over-the-counter pediatric cough and cold medicines said today that parents should not use OTC drugs in children younger than 4 years old.

The drug makers now volunteer to make the label to reflect the new advice.   The Food and Drug Administration has already advised that children younger than 2 years should not use OTC cough and cold medicines.

Both the advices are not in agreement with the demand of physicians and safety advocates. An FDA panel filed early a more than 360-page report asking the FDA to ban use of OTC drugs in children under the age of 6 years.

Critics said there is no evidence to suggest the drugs actually provide any benefits while evidence is abundant that these OTC cough and cold medicines can do more harm than good.

Each year in the United States, about 7,000 children under 11 go to emergency rooms after taking cough and cold medicines, according to the CDC, cited by webmd.com although the majority of cases resulted from unsupervised use of these medicines.

The Centers for Disease Control and Prevention reported in March 2007 that "during 2004--2005, an estimated 1,519 children aged under the age of 2 years were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications."

Last week, the FDA held a hearing on the issue, but said it will not take any action any time soon because it needs more data on efficacy and safety to decide whether to ban these drugs or make them prescription drugs or anything else.

The problem is that trials are few that have been ever conducted to demonstrate the efficacy and safety, according to news media reports.

The drug makers said they consulted with the FDA for the new proposal. It seemed that they want to do something just to relieve some burden now the FDA is facing.

Critics said if what happened with OTC cough and cold medicine happened with alternative medicines or herbal medicines, the FDA may have already banned the alternative medicines many times.

When children have cough and cold, physicians advise that parents need not give their children any medication, let alone the OTC cough and cold remedies.  Simply give them some chicken soap and have them have a good rest.

For more information, read here.