Oct. 11, 2007 -- Pediatricians and other medical experts say the removal of infant cough and cold medicines from store shelves comes not a moment too soon, and nearly all agree that any benefits of the drugs do not outweigh their risks.
The products being voluntarily removed from the market include combinations of decongestants, expectorants and antitussives.
"This is a good step in protecting the safety of children, particularly young children," said Dr. Ian Paul, associate professor of pediatrics at Penn State College of Medicine in Hershey, Pa. "Kids under age 2 are our most vulnerable population... There is no proven benefit for any of these products, and some potential for side effects -- and occasionally, serious side effects."
The voluntary recall by the manufacturers of these products, intended for infants 0-2 years old, comes just a week before an Oct. 18-19 meeting of the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee to further evaluate the medications.
"This is a recognition by the companies making these [products] that, over the last decade, enough information has become available to swing the risk versus benefit ratio toward the risk side," said Dr. Richard Gorman, chair of the American Academy of Pediatrics section on clinical pharmacology and therapeutics.
"At the time these were approved, the FDA extrapolated adult data to children," he added. "In the last 25-30 years, that has been shown to be inaccurate, and occasionally dangerous."
Some FDA advisers have recommended an outright ban on the infant preparations due to safety concerns. But McNeil Consumer Healthcare, the maker of Tylenol and Pediacare brand products, maintained in a statement issued Thursday that the products are safe when used as directed.
"While most parents use these medicines appropriately and follow dosing directions, an assessment of available data on the use of pediatric cough and cold medicines has identified rare instances of misuse leading to overdose, particularly in infants under 2 years of age."
In addition to the 14 products manufactured by McNeil, similar store brand medicines will also be coming off the market, an industry spokesman told ABC News.
However, the recall doesn't affect other cough and cold formulas indicated for children 2 and older -- though the industry may soon institute labeling changes for these products to further emphasize that these products should not be administered to children under 2.
Risks Don't Justify Benefit
Last August, the FDA issued a public health advisory declaring that children under 2 shouldn't be given these remedies without a pediatrician's order due to the risk of serious adverse effects, including death.
The advisory, as well as the scheduled Oct. 18-19 meeting, was largely spurred by a petition in March by a group of doctors concerned over the widespread use of the drugs in children.
And the concern may be warranted. In January, a Centers for Disease Control and Prevention (CDC) study showed that more than 1,500 children under the age of 2 had to be taken to an emergency department due to serious health problems after taking these common remedies in 2004 and 2005. Three of these children died.
Gorman said toxicologists are still investigating whether these medicines likely caused or contributed to the children's deaths. And while the exact role of the drugs is still unclear, he said there exists "no evidence that they are doing any good, and perhaps some evidence that they are doing some bad."
Past reports also suggest that the medications may even pose a risk of life-threatening adverse effects even for children as old as 6. These effects include hallucinations, seizures and potentially fatal heart problems.
"What's happened is over the last 10 years or so, there has been mounting evidence on the lack of efficacy and mounting evidence on the side effects and deaths," Paul said. "The CDC report, as well as the Baltimore petitioners, made it so that neither the FDA or the companies could ignore the evidence."
At least one professional doctor's group has already questioned the effectiveness of the medicines as well. Last year, the American College of Chest Physicians recommended that parents avoid giving cough and cold medicines to their children, claiming that the preparations do not work and that they were potentially harmful.
Part of the problem may be that most of these preparations are actually combinations of different types of medicines -- each with their own roster of potential side effects.
Dr. Tina Cheng, director of general pediatrics and adolescent medicine at Johns Hopkins Children's Center in Baltimore, Md., said that, for example, while overdoses of decongestants can spur irritability, headaches and vomiting, antitussives and expectorants present in the same preparations can chip in side effects of their own.
Parents have also been known to add antihistamines to this list, though these medicines are not marketed for children under 2. These drugs may add dizziness, sedation and confusion.
"There have been some cases that have been more publicized recently on some overdoses. That led to some awareness of the side effects," Cheng said.
Industry representatives continue to stand by the safety and efficacy of the products, however.
"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda Suydam, president of the trade association Consumer Healthcare Products Association (CHPA), in a statement released Thursday. CHPA represents U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.
"The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority," Suydam continued in the statement. "These medicines are -- and always have been -- safe at recommended doses."
Alternatives to Cough and Cold Meds
Pediatricians say that instead of reaching for the bottle or a pill, parents of young children may have other, low-tech methods at their disposal to ease symptoms.
Paul suggests nonaspirin pain relievers, such as Tylenol, ibuprofen and Motrin, among the possible solutions.
"Try and keep them well-hydrated with saline nasal drops and humidified air," he added. "If a child has difficulty staying hydrated or labored breathing, or if symptoms are getting worse after three to four days, I would want to see them and reevaluate."
Most importantly, pediatricians agreed that the preparations should not be used as a quick and easy solution to try and get kids to sleep.
"I know parents just want to do something to help their child feel better and get some sleep, but these products are not the answer to either," said Dr. Ari Brown, an Austin, Texas-based pediatrician and author of "Baby 411: Clear Answers and Smart Advice for your Baby's First Year."
"In fact, I have seen adverse effects -- usually it is irritability or insomnia. Decongestants are like taking an espresso shot and antihistamines can also cause paradoxical alertness instead of somnolence in kids especially under 6 months of age," she said.
"I'd rather have a snotty sleeping baby than a snotty awake one."