More Pediatric Research a Must
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.
As a dad and a doctor, I find this a very scary topic. I used to think that as long as my patient’s or I dosed the children’s cold & cough medications right, then everything would be OK. But when I researched this further, it turns out that children have died from “over dose” of ALL THE MAJOR CHILDRENS COLD AND COUGH MEDICINES even when given the correct dose (http://pediatrics.aappublications.org/cgi/reprint/108/3/e52?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=cough medications&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT).
Here are a few interesting facts:
1. Last October 2008, the drug companies promised the FDA that they would change all their labeling to say “do not use” for children under the age of 2, but I was just in the store last week, and a number of packages still had the old labeling!
2. The FDA reviewed safety and effectiveness data this last fall and its expert panel said that “right now the current cold & cough medications should not be given to children under 6.” Here is a link to the FDA’s minutes, “http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf”, see page 6. The FDA made a public advisory in January 2008 about never using it for children under 2, because the Drug companies are fighting them on the panels ruling to never use cold and cough medications on children 2 to 6. Since these drugs were previously allowed by the FDA, the FDA is forced to go though “due process” before they are willing to make an official public statement about never giving these medications to children 2 to 6.
3. The number of infant deaths attributed to cold and cough medicines is dramatically underreported. New research published in the Journal of the American Academy of Pediatrics demonstrated that there were at least “10 unexpected infant deaths that were associated with cold-medication” in 2006 alone in the state of Arizona. Extrapolated over the US and Canadian population, that would be over 500 deaths a year associated with cold-medication! (http://pediatrics.aappublications.org/cgi/content/abstract/122/2/e318)
The thing that the drug companies don’t want anyone to know is that these medications never underwent the rigorous safety and effectiveness studies modern medications have to go though, they we grandfathered in the early 1970’s because at that time experts felt like they seemed to work, and they seemed safe enough.
Interestingly, some researchers from Penn State have shown that Buckwheat honey is better then the OTC drugs for children’s cough. There is a web site that talks about this, and gives lots of research to help parents be better informed about how to help their kids. Check out http://www.honeydontcough.com/
-Daddydoctor