With cold and flu season approaching, some local physicians recommend that parents not give over-the-counter cough and cold medicines to children younger than 2 and use caution in giving them to older children.

Parents should consult a doctor before using the medicines in children ages 2 to 6, said Dr. Deborah Gentile, research director of the pediatrics department at Allegheny General Hospital.

Dr. Raymond Pitetti, associate medical director of the emergency department at Children's Hospital, questioned whether the drugs should be given to children younger than 6 and said parents should consult a doctor before administering them to older children.

Their comments came as the U.S. Food and Drug Administration held a public hearing yesterday in Maryland regarding over-the-counter cough and cold drugs marketed for pediatric use.

At the hearing, some doctors urged regulators to seek removal of the drugs from store shelves until the products are found safe and effective. They said that if the agency lacks the power to recall the medicines, companies should at least stop promoting them.

The Consumer Healthcare Products Association, a Washington trade group that represents makers of nonprescription drugs, said most side-effects are caused by accidental overdose and misuse, which can be reduced with better packaging and education. Recalling these products from the market isn't necessary and may lead to more overdoses on adult-strength formulas, company representatives told FDA officials.

When the FDA set standards for the medicines some 30 years ago, no separate studies were conducted for children.

Such studies are much needed, said Dr. David Bromberg, a Frederick, Md., pediatrician who testified on behalf of the American Academy of Pediatrics.

Until clear data is available on how the medications work in children and how they might provide a benefit, "safety concerns far outweigh their use," he said.

Instead, he recommended saline nose drops or use of a humidifier for very young children. Those measures, along with honey or other preparations to soothe sore throats, could be used in older children.

Ibuprofen or acetaminophen also can be administered safely, though a physician should be consulted before using them in very young children, he said.

Serious problems that have been reported in children using cough and cold medications include breathing lapses, seizures and stroke, though those cases have been relatively rare, he said.

A study led by Dr. Pitetti and published in August in the journal Pediatrics focused on apparent life-threatening events triggered by poisoning in children under 2 who came to the Children's emergency department from March 1997 to August 2006.

The study found that among 274 children who had toxicology screening tests, 13, or nearly 5 percent, tested positive for an over-the-counter cold preparation, though no parent admitted to giving their child the medicine.

The researchers recommended that the screens be included as part of the evaluation when children come to the emergency department with an apparent life-threatening event.

Issues related to cough and cold medicines are the fourth most frequent group of calls received by the Pittsburgh Poison Center for children under 3, following acetaminophen, household cleaning products and health and beauty aids, said Dr. Edward Krenzelok, a doctor of pharmacy and the center's director.

But serious adverse events resulting from those incidents are rare, said Dr. Krenzelok, who is also a professor of pharmacy and pediatrics at the University of Pittsburgh.

In March 2007, the FDA received a petition submitted by a number of pediatric health care professionals that raised concerns about the safety and effectiveness of the cough and cold products in young children.

Last October, makers of a number of infant cough and cold medicines began pulling their products from store shelves. Later that month, the FDA convened an advisory group that agreed new studies were needed and suggested that pediatric cough and cold drugs should not be used by children under 6.

In January, the FDA issued an advisory recommending that the over-the-counter drugs not be used to treat children under 2.