After federal regulators and private doctors warned of potential health risks to children, drug companies said Thursday that they will voluntarily withdraw over-the-counter cough-and-cold medicines for infants and toddlers younger than 2.
The withdrawal does not include the medicines for children older than 2, even though doctors have warned that the products could pose health risks to kids up to 6.
President Linda Suydam of the Consumer Healthcare Products Association (CHPA), which represents the drugmakers, said the medicines are safe and effective when used as directed, and that "the vast majority of parents and caregivers" use them properly.
But Suydam also said that researchers have recently identified "rare patterns of misuse leading to overdose," particularly in infants.
The products being withdrawn include over-the-counter infant cold medicines such as Tylenol, Dimetapp, Robitussin, Triaminic and Little Colds.
The companies have posted information on their Web sites for alternative products.
Product labels currently recommend that parents check with a doctor before giving the medicine to babies and toddlers. Now, the Food and Drug Administration and the CHPA recommend that the labels read "do not use" for children younger than 2. The FDA will discuss officially changing the labeling during public meetings Oct. 18 and 19.
The medicines have come under much fire. In September, FDA researchers recommended that their agency ban over-the-counter, cough-and-cold products for kids.
The researchers found that 54 children had died from 1969 to 2006 after taking kids' medicines that use the ingredients ephedrine, pseudoephedrine and phenylephrine. The FDA also found that 69 deaths of children were linked to antihistamines that contained
diphenhydramine, brompheniramine and chlorpheniramine.
Most of the children who died were younger than 2, and the FDA said that the medicines haven't been proven to work in little kids.
Earlier research by the Centers for Disease Control and Prevention found that 1,500 children younger than 2 had suffered serious health problems after using the medicines.
The American Academy of Pediatrics also has warned that kids' cough-and-cold products are not safe or effective for kids younger than 6.
Joshua Sharfstein, Baltimore's health commissioner, says that "the problem with these products is there is no evidence that they're safe or effective, so doctors have no basis for deciding what safe and effective use may be."
Sharfstein, a pediatrician, says it's "a good first step" to withdraw the products for kids younger than 2, but that medicines for children up to 6 also should be pulled from stores.