In response to fears that over-the counter cough and cold medicines could harm children rather than solve their health problems, pharmaceutical companies conceded Tuesday that children younger than four should not be given such drugs.

Therefore, they will put that message on the products’ labels, according to the Consumer Healthcare Products Association, a trade group for makers of over-the-counter drugs.

“We are doing this voluntarily out of an abundance of caution. The vast majority of the serious adverse events are in 2- to 3-year-olds. They are the ones who get into the products by being curious toddlers,” Linda Suydam, president of the Consumer Healthcare Products Association, said in announcing the changes on behalf of the companies.

The decision came just one week after the American Academy of Pediatrics asked the Food and Drug Administration to recall over-the-counter cough and cold medicines for children younger than six, arguing that such drugs pose serious health threats on them. Moreover these medications proved ineffective in a series of cases while thousands other cases ended up in the emergency room with serious adverse effects such as neurological problems, increased blood pressure and hallucinations. At the same time, pediatrics said home remedies such as honey and the classic chicken soup are just as effective as commercial products.

However, the FDA said it needs more data on whether these drugs are safe and effective for children between 2 and 6 years old before taking any action. The FDA fears that once these drugs banned, the situations might get even worse, as parents would have to treat their kids with adult medicine, which are much powerful and might have even worse side effects.

On the other hand, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said that the agency “supports this voluntary action that’s been taken by the industry. Parents should follow, very carefully, the directions on the package.” Moreover, they should not give kids multiple products at the same time.

Democratic Senator Chris Dodd welcomed the pharmaceutical industry’s decision and at the same time criticized the FDA for not taking the needed measures to prevent more accidents involving cough and cold remedies. At the same time, he said he called the FDA “to take swift action” instead of relying on the industry to restrict use of pediatric cough and cold medicines.

The new labels will appear on store shelves this year. However, the products with old labels will remain on shelves, as the FDA has not indicated a need to recall them.

Cough and cold medicines have been given to children for decades, but they were never scientifically tested to see their efficiency in kids. According to recent studies, these drugs proved to have some untoward side effects, mostly stemming from accidental overdoses.

In October 2007, the FDA received 54 reports of death in children linked to decongestants containing the ingredients pseudoephedrine, phenylephrine and ephedrine from 1969 to Sept. 13, 2006, and 69 reports of deaths linked to antihistamines with the ingredients diphenhydramine, brompheniramine and chlorpheniramine. Most of these deaths occurred in children younger than two.

Problems with cough and cold medicines send some 7,000 children to hospital emergency rooms annually, according to a study released by the US centers for Disease Control and prevention in January 2008.

Parents spend at least $286 million a year on cough and cold medicines for children, according to the Nielsen Co. market research firm. Another report released by Boston University researchers found that in any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds. Given these figures, it’s no wonder there are so many kids ending in the ERs.