FDA to Revise Rules For Cold Medications Meant for Children ... Washington Post August 23, 2008

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http://www.washingtonpost.com/wp-dyn/content/article/2008/08/22/AR2008082202698.html?hpid=moreheadlines FDA to Revise Rules For

Cold Medications Meant for Children By Rob Stein

Washington Post Staff Writer

Saturday, August 23, 2008; A02 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 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 A. Funderburk of the Consumer Healthcare

Products Association. "What's important is that parents know how to

prevent misuse and accidents."