Sunday October 5, 2008 (foodconsumer.org) -- On Thursday, physicians and consumer advocates at a public hearing asked the U.S. Food and Drug Administration (FDA) to ban over-the-counter or OTC cough and cold remedies for children younger than 6 years or make them prescription drugs.   And the agency said it will take time for it to consider taking any action.

There has been no evidence that these OTC cough and cold products help children under the age of 6 years and on the contrary evidence is abundant that these remedies could pose life threatening adverse events in children of this age group.

Last year, the FDA issued an advisory to warn parents not to give OTC cough and cold medicine to children younger than 2 years, but experts and consumer safety advocates said that was not enough and there was no reason to keep those useless, yet potentially dangerous products on the Market.

Dr. John Jenkins, who heads the FDA's Office of New Drugs was cited by healthday.com as saying this time that the agency needed more data on efficacy and safety of these OTC medicines for children between 2 and 6 years to consider any action. But few trials have been conducted for these medicines.

Health officials at the FDA said the agency also is concerned that a swift ban, which has been supported by pediatricians' groups, could prompt parents to give adult medicines to their children.

But delay to take action is not the option to the advocates.   In January, the FDA already updated its health advisory that cold and cough preparations including decongestants, expectorants, antihistamines, and cough suppressants, should not be used in children younger than 2 years.

In Sep 2007, safety experts for the FDA said in a 356-page report that the agency should ban all over-the-counter cough and cold medicines for children under 6 because these OTC remedies are neither effective nor safe for such young children.

Experts recommended that all cough and cold medications be removed from the market and products such as droppers, cups and syringes used for the products should be standardized to minimize the risk of overdosing.

According to a report last year by the New York Times, the reviewers concluded that there is little evidence to indicate that these medicines are effective in helping young children and there is sufficient evidence that these products pose a serious risk to young children.

The report was cited as saying that at least 54 young children died after taking decongestants and 69 died after taking antihistamines since 1969.   The real death toll can be much bigger because the reporting of adverse reactions is not mandated.

The Consumer Healthcare Products Association, an industrial trade organization that has defended the safety of cough and cold medicines for pediatric use, also made it own 156-page safety review and recommended that a warning label be printed to alert parents not to use the products in children younger than 2.  But it has maintained that there is no harm to kids between 2 and 6.

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."

The CDC confirmed that “three cases of infant deaths in two states during 2005 that were determined by a medical examiner or coroner to have been caused by cough and cold medications."

It is not more than speculation that taking cough and cold medicines poses risk in young children.

Experts said at high doses, the ingredient(s) in cold medicines can affect the heart’s electrical system, leading to arrhythmias. Some medicines affect the blood vessels, potential leading to hypertension and stroke. Children may get injured even at recommended doses.

These cough and cold remedies are not needed in the first place.

In 2006, the American College of Chest Physicians also released clinical practice guidelines for management of cough, advising health-care providers not to recommend cough suppressants and other over-the-counter cough medications for young children because of potential risks to children.

At the hearing held on Thursday, Dr. Alejandro Necochea, representing Public Citizen called on the FDA to immediately ban sales of all OTC cough and cold medicines for children under the age of 12 years because children did not benefit from the drugs.

Physicians agreed that children who are experiencing cough and or cold do not need any medicine for recovery although in some cases use of such remedies provides some palliative effect.