Oct. 2 -- THURSDAY, Oct. 2 (HealthDay News) -- After recommending earlier this year that children under the age of 2 not receive over-the-counter cold medicines, the U.S. Food and Drug Administration on Thursday is meeting with the public to help answer an even more important question: Should kids' cold medicines remain "OTC" at all?
The issue is not a new one for regulatory bodies or the public.
In January, the FDA issued an updated health advisory recommending that over-the-counter (OTC) cough and cold preparations not be used to treat children under the age of 2 due to the possibility of life-threatening complications. These products include decongestants, expectorants, antihistamines and cough suppressants.
Just prior to the advisory, the makers of dozens of cough and cold remedies marketed for infants voluntarily recalled the products.
Despite scant evidence that such remedies are actually effective in children or adults, an estimated 10 percent of American kids take one or more cough and cold medications during a given week.
Yet the preparations can do more harm than good, research suggests.
An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.
And the U.S. Centers for Disease Control and Prevention reported that some 7,000 American children under the age of 11 are treated each year in hospital emergency rooms because of problems with cough and cold medications.
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 lawsuit 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 will be testifying at the hearings. "The current hearings are looking at a wider pediatric age range," he said.
"If the FDA takes those medications off the market, the impact on the public is unknown at this point," said Chanin Wright, a pediatric clinical specialist with Scott & White and an assistant professor of pediatrics at Texas A&M Health Science Center College of Medicine. "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.
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