FDA to Revise Rules For Cold Medications Meant for Children

By Rob Stein
Washington Post Staff Writer
Saturday, August 23, 2008

The Food and Drug Administration yesterday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market.

In response to rising concerns that the products are ineffective and could be unsafe, the agency said that, for the first time in decades, it will revamp the criteria that have allowed the products to remain on drugstore shelves.

"Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

As the first step in that process, the agency will hold a special hearing Oct. 2 to begin to consider a series of questions, including: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available?

"This is the beginning of getting drugs that are widely used in children in the over-the-counter world using the same modern approach we've started using for prescription drugs," Woodcock said.

The announcement is the latest response to a petition filed in March 2007 by a group of pediatricians asking the FDA to restrict the use of the products, citing a lack of evidence that they work and mounting evidence that they can cause hallucinations, seizures, trouble breathing, heart problems and other complications, including occasionally deaths.

The petition argued that the products had been allowed to stay on the market because they were approved at a time when it was not considered appropriate to test medications directly in children. Instead, studies in adults were extrapolated to children, a practice now considered inadequate, the petition said.

A week before the FDA convened a panel of experts to consider the petition in October 2007, drugmakers voluntarily pulled all over-the-counter cough and cold products for children younger than 2, though the companies said the problems were overwhelmingly caused by parents accidentally giving overdoses.

After an exhaustive review, the panel concluded that there was little evidence the remedies worked for children younger than 12, recommended that they not be used at all in those younger than 6, and called for new research to establish their safety and effectiveness directly in children.

In January, the FDA issued a public health advisory formally warning against using the products on children younger than 2, but it said the agency was still considering what to do about older children. Yesterday's announcement was welcomed by critics, who predicted the process would eventually result in the products being pulled from the market.

"It's a significant step forward," said Baltimore Health Commissioner Joshua M. Sharfstein, who led the FDA petition. "This is how the agency can take these products off the market. I think this signals the agency is going to apply a modern standard of safety and efficacy to these products, and that is a standard these products cannot pass."

The industry, however, has vowed to keep the products on the market, saying they offer relief for older children as long as they are used according to directions.

A spokeswoman for the drugmakers said yesterday that she was confident the products would remain on the market and that drugmakers were looking forward to working with the agency. Companies had already begun a new set of studies designed to provide the agency with the new data necessary for its review, she said.

"These medications are safe and effective when used correctly," said Elizabeth A. Funderburk of the Consumer Healthcare Products Association. "What's important is that parents know how to prevent misuse and accidents."

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