If your baby is sick from the common cold, and your trying to decide whether or not to give your baby over-the-counter cold medicine be sure to read the fine print. If the bottle says to not give it to children under the age of 2, DON'T. Other parents have ignored this precaution, and as a result, 10 infants have died. The investigators found that of 21 infants who died unexpectedly and had autopsy data available, 10 had evidence that they been given cough or cold medication shortly before they died. The findings, published in the journal Pediatrics, do not prove that the medications caused or contributed to the infants’ deaths, but they add weight to a recent warning from the Food and Drug Administration (FDA) that parents not give cough and cold remedies to children younger than 2. “We strongly recommend that parents not use these medications,” said Dr. Mary Ellen Rimsza of the University of Arizona College of Medicine in Tucson, the lead researcher on the new study. Cold and cough medications typically contain a combination of decongestants, antihistamines and cough suppressants — all of which can have serious side effects in young children, including increased blood pressure, heart rate disturbance, and depressed breathing. While these dangers are now recognized, until now no study had examined the possible role of cough and cold medications in unexplained infant deaths.
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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
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