I was happy to see last week’s FDA column by Dr. Murray Lumpkin on children’s medications. Lumpkin, FDA’s Deputy Commissioner for International and Special Programs, was filling in for Commissioner “Andy” von Eschenbach, who has been writing weekly on the FDA website about current issues. Lumpkin pointed out that, until recently, nearly 75% of medicines used in children did not have prescribing information on how to safely administer or dose medicines for children.
“Children are not simply ‘little adults,’” he wrote, pointing out that the pharma and medical industry need to do more pediatric science and studies.
I couldn’t agree more. Many of us have been frightened by recent alerts from FDA that cough and cold medicines should not be administered to children under age 2, and an FDA committee advised that they probably shouldn’t even be used in children under age 6 because these medications have no proven effect in individuals this young. How many parents out there, including myself, have given a toddler a dose of Benadryl during those endless-teething nights? Probably the same number of parents now scared to bring out the Benadryl or other cough/cold medications again in the presence of their child.
The fact that we can’t safely administer these medications any longer is more than worrisome. What’s a parent or child caregiver to do when a child is experiencing discomfort or pain? A rubber nose bulb or humidifier, some of the suggested alternatives, just don’t cut it at 2am.
Another important factor when it comes to pediatric medicine, notes Lumpkin, is that many parents don’t have access to this news. FDA now has public Pediatric Advisory Committee meetings to discuss information and there is info on the agency’s website, but not many parents have the time or knowledge to seek out these resources. They simply trust that what they pick up on the pharmacy shelf is not going to hurt their child—and unfortunately, many don’t read the warning labels on the side of the drug box.
“Children are not second-class citizens,” writes Lumpkin. They are indeed going to be around far longer than we are, and the ones developing and testing medications for us “aging” adults. So let’s give their health and drug-handling capacity more consideration and put more funding into pediatric research.