FDA Neglecting Its Responsibility to Protect Children From Risky, Ineffective Cough and Cold Medicines

Jan. 17, 2008

FDA Neglecting Its Responsibility to Protect Children From Risky, Ineffective Cough and Cold Medicines

Products Should Be Banned for All Children Under 12,   Public Citizen Says

WASHINGTON, D.C. – By simply warning parents not to administer over-the-counter cough and cold remedies to children under the age of 2, the U.S. Food and Drug Administration (FDA) has failed to properly address the glaring risks presented by this category of drugs, Public Citizen said today. 

In fact, there is no evidence that these products are safe and effective for children under the age of 12.   The agency didn’t even follow the recommendation of its own advisory committee, which voted on Oct.19 to limit these products to children over the age of 6.

Drugmakers have long claimed that pediatric cough and cold preparations, made popular through heavy marketing of a dizzying variety of combination products in child-friendly flavors,   provide relief for cough and cold symptoms. Testifying at the FDA’s October hearing, Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, said the data show that isn’t the case. 

“The advisory committee declared the products were ineffective in younger children, but we were not able to identify a single adequately designed study that compared the efficacy of these products in older and younger children,” Lurie said. “Thus the product’s efficacy remains unproven in all children under the age of 12.

“That is why the news today that the FDA will recommend restricting these products only to children under 2 is so disappointing and ultimately will be detrimental to the millions of older children who will continue to swallow these medications.”

Lurie warned that reports of serious adverse events cannot be ignored. They include death, convulsions, rapid heart rates and decreased levels of consciousness.

“The companies have known for decades that their products are unproven, yet they have continued to foist them on concerned parents who believe that the FDA protects them and their children from ineffective medications,” said Lurie. “Simply because these drugs are well-tolerated by many children is not an adequate rationale for allowing them on the market. The law is clear that ineffective medications are not to be sold, no matter how safe they appear to be.” 

READ Dr. Lurie’s testimony.

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