Recall Alert: Infant cold and cough formulas pulled for potential misuse

After an FDA investigation into the deaths of 54 children, major brands of infant oral cough and cold medicines are being pulling off store shelves, effective October 11, 2007.

The brands being voluntarily withdrawn are:

Although the medicines are “safe and effective when used as directed” patterns of misuse leading to overdose have recently been observed, particularly in infants.

The dosage information on the box or label of the medicines state that a doctor must be asked before using the formulas for children under two years old. And that’s where there is potential for misuse – when the dosage is not followed. According to an interview of Joshua Sharfstein, Baltimore’s health commissioner, who first began the investigation, the dosage on the brands is based on age and not weight, which is the more critical information calculating the right dosage.

Joshua Sharfstein, Baltimore’s health commissioner, says, “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 under 2, but that those for children up to 6 also should be pulled.

The Food and Drug Administration found that 54 toddlers and infants died after taking children’s medicines with ephedrine, pseudoephedrine and phenylephrine, and 69 children died after taking antihistamines that contained diphenhydramine, brompheniramine and chlorpheniramine.

The recall does not affect medicines intended for children age two and older.

[sources: CHPA; USAToday]