They said evidence is lacking to suggest that taking such OTC medicines help children who suffer coughing and colds for which pediatricians often advise parents not to use any medicine in the pediatric patients at all.

Safety advocates also said evidence is abundant to suggest that these drugs can do more harm than good.  

A study published in the Mar-April 2008 issue of Pediatr Nurs says “ during a 2-year period from 2004 and 2005, emergency departments treated over 1,500 children under the age of 2 years for adverse events related to over-the-counter (OTC) cough and cold medication use; these incidents include 3 infant deaths.”

Physicians groups have repeatedly asked the FDA to regulate the OTC cough and cold medicine based on the same reasons presented to the agency on Thursday.

Last year, the FDA posted a health advisory regarding use of OTC cough and cold remedies to warn parents not to give their kids the OTC drugs after a panel of experts commissioned by the agency recommended a ban on use of the medicines in children under 6.

But the FDA did not take any action to ban anything.   This time, health officials at the FDA said the agency is concerned that a swift ban, which is supported by pediatricians' groups, could prompt parents to give adult medicines to their children.

The nearly $1 billion-sales-a-year industry volunteered last year to put a warning for OTC cough and cold medicines for use in children under 2 years.   But it says there is no need to ban their use in children between 2 and 6 years.

The FDA said before it can take any action, it needs more data on safety and efficacy of the OTC cough and cold medicine which can be found nowhere because these drugs have not been subject to rigid trials.