FDA exploring safety of children's cough and cold medicines

Federal regulators tomorrow will explore setting new standards for over-the-counter cough and cold remedies intended for children.

A year after manufacturers voluntarily pulled the medicines for children under 2 off store shelves, the Food and Drug Administration is holding a hearing in Washington to guide testing for safety and effectiveness that has never been done. Like many drugs for children, the cough and cold medicines were approved based on trials in adults, a practice now discredited by research that shows children are more complicated than "miniature adults."

Dr. Michael Shannon, a pharmacologist and chief of emergency medicine at Children's Hospital Boston, will testify at the hearing, which will consider what types of studies need to be done to evaluate the drugs, whether the drugs should require a prescription, and how dosages should be calculated. The process could lead to removing the drugs from the market, making them available by prescription only, or restricting combinations of different ingredients, among other possibilities.

"The FDA gave a clear message that they don't feel they can give carte blanche in reference to cough and cold medicines as safe and effective in the absence of data," Shannon said in an interview this week. "I interpret this as a strong and clear message from the FDA that these products need to be examined more closely than they were when they were first approved."

The American Academy of Pediatrics concluded that there was little evidence that the medications worked and that there were growing reports of harm, including death. In January the FDA followed with an advisory warning parents not to give the medicine to children under 2 and in August called for more study.

Shannon said he's seen a difference since the cough and cold medicines for the youngest children disappeared from store shelves last October.

"It's been quite notable," he said. "My general impression is the number of emergency department adverse events in children under 2 who have been exposed to cough and cold preparations has gone down since manufacturers voluntarily ended (marketing) them in October 2007, just prior to the FDA recommendation."

There had been concern that parents would resort to medicines intended for older children or even adults, but that did not happen, Shannon said.

"These products are not in homes, they're not being given to children, and parents are not reaching for substitutes," he said. "The message is getting out."