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Cold remedies put children at risk, group says
City health chief, 15 pediatric experts petition FDA for stricter regulations

Baltimore Sun | March 1, 2007
Frank D. Roylance

Parents of young children are spending billions of dollars on over-the-counter cough and cold remedies that don't work, and which could make the kids sicker, according to a group of leading pediatricians.

"When you see multiple deaths, hundreds of calls to Poison Control and thousands upon thousands of kids using these drugs in the city every day, and they don't work and they're not safe, it's a fair issue for public health," said Dr. Joshua Sharfstein, Baltimore's commissioner of health.

Sharfstein and 15 leading pediatric experts petitioned the U.S. Food and Drug Administration today, urging the agency to stop drug makers from marketing the products to young children.

As many as 900 Maryland children younger than 5 overdosed on the medications in 2004, the petition alleges. The deaths of at least four children in Baltimore have been linked to unintentional overdoses in the last six years.

"Over-the-counter cough and cold preparations are neither safe nor effective for use in young children," the petitioners argue. "The FDA has never conducted an appropriate analysis to support their widespread use, and expert organizations agree that they are ineffective and pose a risk to health."

The petitioners asked the FDA to tell the public that over-the-counter cough and cold remedies are ineffective and potentially dangerous for young children.

They also urged the agency to tell drugmakers that continued marketing these products for infants and young children is not supported by scientific evidence and could lead to enforcement action.

Among those joining Sharfstein in the petition were Dr. Janet Serwint, professor of pediatrics at the Johns Hopkins University; Dr. Steven J. Czinn, chairman of pediatrics at the University of Maryland School of Medicine; and Dr. Michael Shannon, professor of pediatrics at Harvard Medical School.

"These are very senior pediatricians," Sharfstein said. "That kind of expertise is not something the FDA gets petitions from every day."

Last fall, Sharfstein wrote the FDA to express his concern about the FDA's regulation of over-the-counter cold remedies to children. He got a letter of thanks, but "nothing since then," he said.

He then launched a review of FDA regulation of the products, and found that the agency has never conducted a thorough review of the scientific evidence of the drugs' safety and effectiveness in children.

It "doesn't make sense," Sharfstein said. "And we were able to get some really impressive people to agree."

Coughs and colds are frequent in young children, and parents often turn to remedies that combine cough suppressants, expectorants, decongestants and antihistamines. In 1990, sales of these products totaled nearly $2 billion.

Repeated studies have found the preparations are generally harmless but no more effective in children than placebos.

The FDA has not restricted marketing to young children on the grounds that the drugs are "generally recognized as safe and effective." But a growing body of evidence in recent years has suggested that they are not.

Last year the American College of Chest Physicians released clinical practice guidelines advising caregivers not to recommend cough suppressants and other over-the-counter medications for young children because of their ineffectiveness and the increased risk of complications and death.

Last month, the Centers for Disease Control and Prevention reported that 1,519 children younger than 2 were treated in emergency rooms in 2004 and 2005 for overdoses and other complications related to cough and cold medications. Three infants less than 6 months old died.

"Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children aged [less than] 2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a health care provider," the report concluded.

In some children, unintentional overdoses have caused heart rhythm changes, cardiopulmonary arrest, hallucinations, psychoses, hypertension and seizures, according to research cited in the petition.

The medications' lack of efficacy means "there is no justification to tolerate a real risk of severe side effects," the petitioners argue.

Dr. Steven J. Czinn, chair of pediatrics at the University of Maryland School of Medicine, was one of the petition's signers. He said parents concerned about their kids' cough and cold symptoms should have them examined by a physician to be sure the illness is viral, without serious complications.

"As long as the child is generally healthy, the best thing to do is let the virus run its course, and generally they'll get better as quick or quicker than when they take these medicines," Czinn said.

If a child has significant respiratory distress, or wheezing, he said, "there are medications that are effective. But routine coughs, colds, sniffles and runny nose -- they're very uncomfortable for the child, and for parents -- but generally speaking these [over-the-counter] medications are not going to deal with that discomfort.



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