FDA Wants More Time to Study Cold Meds for Kids

Oct. 3 -- THURSDAY, Oct. 2 (HealthDay News) -- The U.S. Food and Drug Administration will take its time considering whether to ban over-the-counter cold medicines for children, a top agency official said Thursday at a public hearing on the matter.

Dr. John Jenkins, who heads the FDA's Office of New Drugs, said the agency needed to get more data on whether "OTC" medicines are safe and effective for children between 2 and 6 years old before taking any action, the Associated Press reported.

FDA officials are also concerned that an immediate ban, which is supported by leading pediatricians' groups, might cause parents to give adult medicines to their kids.

"We do not want to do something that we think will have a positive impact, only to have an unintended negative," Jenkins said at the hearing, according to the AP report. "That could be an even worse situation."

The FDA, which earlier this year recommended that kids under 2 not receive OTC medicines, was meeting with the public to help answer the even more important question: Should any kid get OTC medicines?

The issue is not a new one for regulatory bodies or the public.

In January, the FDA issued an updated health advisory that cough and cold preparations not be used to treat children under the age of 2 because of possible life-threatening complications. These products include decongestants, expectorants, antihistamines and cough suppressants.

Just prior to that 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.

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.