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FDA urged to act fast on kids' cold remedies

The Baltimore Sun

A federal review of safety concerns about cough and cold remedies ought to be quick and result in restrictions on the products' marketing and use, Baltimore's health commissioner said yesterday.

Dr. Joshua Sharfstein and a group of prominent pediatricians petitioned the Food and Drug Administration Thursday to warn parents against giving cough and cold medications to young children. The group wants the FDA to require drugmakers to stop marketing products for infants and babies. It also wants warning labels stating that the medications "have not been found to be safe or effective" for children under 6.

FDA officials announced plans yesterday to review the matter over the next several months. But an agency official told reporters that there is no need for the FDA to take immediate action.

"If we thought there was a need to come out with an immediate statement, we would do so," said Dr. Charles Ganley, director of the Office of Nonprescription Products.

The petition cited the deaths of four city children - all under the age of 4 - in the past six years that have been linked to cough and cold medications. It also noted that as many as 900 Maryland children younger than 5 overdosed on the medications in 2004.

"I think this is something that should be wrapped up fairly quickly because the evidence on this is clear. They don't work, and they're not safe," Sharfstein said.

"I'm pleased they're taking the issue very seriously - that's the big picture. But it shouldn't be that hard of a decision," he said.

Ganley promised that the review will include an assessment of the safety and efficacy of cold and cough medications for children, as well as how dosage levels for them are drawn up. In the meantime, he said, parents should be careful to follow directions on the products.

"Parents need to adhere to those dosing directions. If the directions are to consult a physician, parents need to adhere to that," he said at a briefing in Washington.

In separate interviews, drug industry experts argued that cold and cough medications are clearly labeled with instructions for children and that they remain one of the most widely used drugs given to children.

They also argue that adverse reactions being reported by health experts are most likely the result of label directions not being followed.

"The important thing is read the label," said Dr. Heinz Schneider, vice president of scientific and regulatory affairs for the Consumer Healthcare Products Association.

Schneider, a physician, added that he has often given cold remedies to his children over the years.

The FDA's Ganley said that part of the problem is that when many of the cold and cough medications were approved for over-the-counter use in past decades, the dosage levels for children were extrapolated based on studies of the drugs in adults.

He added that the issue is more complicated than simply prohibiting use of the medications in young children. It might be a matter of children being given adult doses, he said.

"There are clearly situations where dosing situations are not being followed," Ganley said.

Sharfstein said one problem with the FDA's response is that some cold medications have no dosing recommendations for children. He suggested that parents throw out their cold medications rather then give them to children under age 6.

In his review of FDA regulations, he found the agency had never conducted a thorough study of the scientific evidence of the drugs' safety and effectiveness in children.

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.

The Centers for Disease Control and Prevention reported in January 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.

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 totaled nearly $2 billion.

Studies have found that the medicines 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.

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

Sharfstein first made his concerns public last fall when he wrote to the FDA, a move that was reported by The Sun in October. He persuaded a group of 14 senior pediatricians to join him in filing the formal request after the initial effort prompted only a letter of thanks.

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

Czinn 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," he said, "and generally they'll get better as quick or quicker than when they take these medicines."

If a child has significant respiratory distress or wheezing, "there are medications that are effective," he said. "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."

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



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