FDA Wants More Time to Study Cold Meds for Kids

At Thursday's hearing, Dr. Alejandro Necochea, a research associate with Public Citizen's Health Research Group, called on the FDA to immediately ban all OTC cough and cold medicines for children under 12, saying kids who take the drugs do no better than those who take no drugs at all.

"In the absence of direct evidence that a product is effective, no amount of toxicity is acceptable," Nocochea said. Reports of serious adverse effects linked to these medications include convulsions, rapid heart rates, decreased levels of consciousness and death, Necochea said in a news release issued by Public Citizen.

According to Dr. Michael Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital, the recent debate originally stemmed from a citizens petition by a group of pediatricians who felt that cough and cold medicines were unsafe -- or at least never proven to be safe. This led to the FDA's statement earlier this year regarding young children.

Spigarelli planned to testify at the hearing. "The current hearings are looking at a wider pediatric age range," he said.

Chanin Wright, an assistant professor of pediatrics at Texas A&M Health Science Center College of Medicine, said: "If the FDA takes those medications off the market, the impact on the public is unknown at this point. There's a risk that the parents would turn to adult formulations for their children which could potentially cause harm. I don't think the FDA wants that, so they're asking expert opinion."

In addition to considering whether these medications should be over-the-counter or prescription, the hearings will cover a wide swath of territory, including questions of dosing and age range.

One of the most provocative issues is that of testing: What types of studies, if any, should be conducted in children and how should these studies be designed and powered?

"Testing in children is intensively debated," said Spigarelli. "It is felt by the FDA and most regulatory authorities that it is unethical to test in children, which means that pediatricians and family medicine doctors are left prescribing off-label, because it's equally unethical to let a kid suffer."

According to Spigarelli, 150 or so drugs have been tested in children since the Best Pharmaceuticals for Children Act, passed in 2002. The act extends the amount of time a pharmaceutical company has exclusive rights to market a drug if that company conducts studies in children of drugs the FDA thinks might be useful in younger age groups, he said.

But the reality remains that few drugs have actually been tested in pediatric populations, Spigarelli said.

"The world [notably, the European Union] has shifted to doing more testing on children, but most of the medications used on children have not been tested, and cough and cold medicines are in that category," he said.

More information

Visit the FDA for more on its recommendation regarding over-the-counter cough and cold medications for young children.

SOURCES: Michael Spigarelli, M.D., Ph.D., assistant professor, pediatrics and internal medicine, division of adolescent medicine, Cincinnati Children's Hospital; Chanin Wright, Pharm.D., pediatric clinical specialist, Scott & White, and assistant professor, pediatrics, Texas A&M Health Science Center College of Medicine; Sept. 25, 2008, U.S. Food and Drug Administration notice;Associated Press; Oct. 2, 2008, news release, Public Citizen, Washington, D.C.