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| Fri, Nov. 20 - - Mobile - RSS | |
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Few meds tested for children
Few drugs are tested for use by children.
Date published: 3/9/2003
RECENTLY, I had a patient's mother call me frantically. She had read on the Internet that the medication I had prescribed for her 5-year-old was approved by the Food and Drug Administration only for children 6 and over. I reassured her that this medication is frequently prescribed for 5-year-olds, and since her daughter was as big as most 6-year-olds, there was nothing to worry about. Throughout our discussion, all I could think was, "Little does she know, the majority of what I prescribe every day is not even approved for children at all." Amazingly enough, 75 percent of medications prescribed for children are not approved by the FDA for use in children, because sufficient testing has not been done. Pediatricians are forced to use many medications "off-label," meaning that the FDA hasn't labeled it for children, or not for that particular use. For example, using drops made for eyes in the ear instead. In researching this article, I found that off-label use is more common than I thought, and I suspect other pediatricians would be surprised by the 75 percent number as well. During our training in teaching institutions, where medicine is on the cutting edge, off-label is the norm. I justify it to myself now because I know that the practice is legal, and sometimes there is no choice but to use something that is not FDA approved when a sick child is not improving with standard therapy. I also read as much as I can by experts in the field, and I have used many of these on enough patients to feel comfortable about their safety. The American Academy of Pediatrics has been trying for years to rectify this situation. Unfortunately, there isn't much incentive for drug companies to do the expensive research needed to get approval for use in children. The big money is in adult medications, and it's much easier to get subjects for these tests. In these studies, subjects may get the real drug or a placebo--a sugar pill--and they don't know which they are getting. Different doses are tried to find out how high a dose is needed to get a therapeutic effect and what dose is toxic. Would you want your child to be a subject in that kind of study?
Date published: 3/9/2003
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