Doctors Pressure FDA Panel to Ban Cold Medications for Children

SILVER SPRING, Md. _ Citing deaths, hallucinations, seizures and heart-rhythm disturbances, doctors on Thursday called on a joint U.S. Food and Drug Administration panel to forbid the use of over-the-counter medications for children up to age 6.

If panelists agree the drugs should be tightly restricted, the decision could have an impact on the availability of nonprescription cough and cold products for older children.

Two influential FDA advisory committees _ the pediatric and nonprescription drug panels _ were scheduled to vote Friday on the drugs’ fate. Some doctors say have asked the agency to reconsider rules on the remedies, saying conclusions about the effects of such products on children were largely extrapolated from studies involving adults.

Last week, several major drugmakers withdrew 14 pediatric cough and cold medications for children up to age 2. And during testimony yesterday before the FDA panel, Linda Suydam of the Consumer Healthcare Products Association, which represents makers of nonprescription drugs, advocated withdrawing remaining infant cough and cold preparations.

Experts Thursday estimated consumers spend about $500 million a year on nonprescription drugs for children.

“Overall, if you look at the data that’s available, you’ll come to the conclusion that these drugs are no more effective than a placebo,” said Dr. Wayne Snodgrass of the University of Texas Medical Branch in Galveston. But unlike placebos, he said, the potent ingredients can cause unintended consequences.

Snodgrass is one of several American Academy of Pediatrics members who earlier this year petitioned the FDA to reconsider its stance on the drugs’ safety.

Another petition signer, Dr. Michael Shannon, a professor of pediatrics at Harvard University, said 80 percent of over-the-counter drugs have never been tested in children. Because kids differ physiologically from adults, extrapolating data is not accurate, he said.

Shannon told Newsday that pseudoephedrine and dextromethorphan are among the ingredients raising concerns. Pseudoephedrine can increase the heart rate and if misused can lead to hypertension, rapid pulse rate and cardiac arrest.

Dextromethophan has sedative properties and if misused can produce serious side effects. He and the other petitioners also are concerned about antihistamines’ sedating properties.

Shannon said that differences in drug metabolism between children and adults account for nearly as many problems as issues involving overdoses.

But Dr. Mary Tinetti, chairwoman of the panel, said petitioners reported only 123 deaths over 27 years. “Millions and millions of parents are using these and are voting with their pocketbooks,” she said.

On Long Island, Dr. Ken Steier, a critical care physician and pulmonologist at Nassau University Medical Center, said he would not be surprised if FDA panelists, who are outside experts, advised severe restrictions on the drugs. Even though the FDA is not bound by its panelists’ decisions, the agency rarely, if ever, counters them.

Steier said despite ads promoting safety, many products are multi-ingredient mixtures that are highly concentrated. “There is a very narrow margin of error with these drugs,” he said. “Kids can become overmedicated, which can result in seizures or the child can stop breathing.”

___

(c) 2007, Newsday.

Visit Newsday online at http://www.newsday.com/

Distributed by McClatchy-Tribune Information Services.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.