Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA

Oct. 19, 2007

Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA

Over-the-Counter Remedies Are Harmful, Not Effective

WASHINGTON, D.C. – Children under the age of 12 should not be given over-the-counter (OTC) cough and cold medicines, and remedies aimed specifically at children should be removed from the U.S. market, Public Citizen said today in testimony before the Food and Drug Administration (FDA).

Recent instances of deaths and other toxicities associated with child and infant OTC cough and cold remedies have prompted the voluntary withdrawal of the infant versions of these drugs. This industry action was a response to a citizen petition seeking warnings against the use of cough and cold remedies in children under 6. The FDA has called a joint meeting of the FDA’s Nonprescription Drugs and Pediatric advisory committees, during which Dr. Peter Lurie, deputy director of the Health Research Group at Public Citizen, spoke, detailing the organization’s position on the drugs and giving recommendations for FDA action.

There are two main ways drugs are approved for use in children. One is to show direct proof of effectiveness in children. Alternatively, if a drug is shown to be effective in treating adults, its effectiveness in treating children is often inferred.

According to Lurie’s testimony, an FDA medical officer was able to find only 11 pediatric clinical trials involving cough and cold medications during the past 50 years. These lead the medical officer to conclude that there is no evidence that OTC cough and cold drugs are effective when given to children. This opinion was echoed by the American Academy of Pediatrics, which on Sept. 6, in comments submitted to the docket, wrote that “the OTC cough and cold products, therefore, constitute a group of drugs that do not produce any discernable health benefits in this population [children under six] according to the published peer-review literature.”

This leaves the second method of approval for pediatric drugs: proven effectiveness in adults extrapolated to children. However, there is little evidence that cough and cold medications are effective even in adults, according to a meta-analysis of adult studies conducted in 2002 by the Cochrane Collaboration. The fact that these drugs are ineffective in adults, combined with the results of pediatric trials, should have been enough to prohibit use of OTC cough and cold medicines in children, Lurie said. Moreover, there are marked physiological differences between children and adults, and the hundreds of combination cough and cold drugs on the market have caused confusion for parents. Lurie went further than the citizen petition to argue that the drugs should be restricted for children 12 and under, not under 6 as requested by the petition.

“No matter which path to pediatric approval a cough and cold drug may attempt to take, there is simply no evidence to support the position that these drugs are safe and effective for children,” said Lurie. “In fact, recent data have shown just the opposite – that these drugs often cause serious harm.”

Lurie concluded that the mounting evidence against pediatric cough and cold medications makes a strong case for the drugs to be removed from the market. However, since adult versions of cough and cold drugs will remain on pharmacy shelves, restrictions should be put into place to make it clear that the drugs are not intended for pediatric use.

“Formulations that clearly are intended only for children, such as droppers and syringes, should be removed from the market,” Lurie testified. “It is a mixed message to recommend against newborn and toddler use and then have formulations specifically designed for newborns and toddlers available for purchase.”

Public Citizen also recommended that the remaining adult products be clearly labeled as not being effective in children and being potentially toxic to children. Also, any photographs or representations of children under 12 should be removed from the drug’s packaging. Finally, since many overdoses have resulted from confusion over the contents of multi-ingredient formulations, Public Citizen recommended that the FDA only permit the sale of single-ingredient drugs.

READ Lurie’s testimony.

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