DC Child Accident & Safety Blog

We have discussed concerns over the efficacy and safety of cough and cold medicines for very young children many times in the past.

Now, in reaction to these concerns, the FDA plans to take another look at the reasons why these cough and cold medications were approved for toddlers and infants in the first place. From the article:

In response to rising concerns that the products are ineffective and could be unsafe, the agency said it will revamp the criteria that have allowed the products to remain on drugstore shelves for the first time in decades.

"Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

As the first step in that process, the agency will hold a special hearing Oct. 2 to begin to consider a series of questions, including: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available?

One problem that has led to preventable tragedies is that parents sometimes inadvertently overdose their children. A particular problem has been with concentrated Tylenol infant drops. Due to confusing instructions from pediatricians and to labeling that wasn't always clear, some parents have not realized that the infant drops contain much more of the active ingredient, acetaminophen, then regular children's Tylenol. An overdose of Tylenol or acetaminophen can cause liver poisoning which requires liver transplant. After years of complaints, the Tylenol manufacturer took the concentrated infant drops off the market in October 2007.

The FDA's new look promises to go beyond the infant drops issue and look at the appropriate place of cough and cold medicines in treatment of infants and toddlers.