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Enrollment in drug study ends
Filed under: Health & Safety: Babies
Sanofi-Aventis, the maker of the antibiotic Ketek, announced Friday that it will discontinue the use of children in their drug studies. The drug has been linked to liver failure in adults.The company will not acknowledge any wrong doing in the clinical studies involving children. The manufacturer will only comment that it is only trying to comply with FDA requirements regarding the testing of children.
The use of Ketek has been shown to cause an increase in liver failure of almost 4 times the normal rate in adults. The end of these trials is a relief. Any testing that puts a minor at risk is not worth the harm that child might incur.
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ReaderComments (Page 1 of 1)
6-12-2006 @ 8:22PM
Brenda said...Whether or not a drug company tests a drug on children, doctors will prescribe it "off-label" to children. At least in a controlled study side effects should be more readily apparent than anecdotal evidence from a few doctors who prescribe the drugs once or twice, if patients (or their parents) bother to report side effects at all.
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6-13-2006 @ 4:07PM
webhill said...All testing will "put minors at risk" if minors are used in the testing. That is why it is called "testing," and not "using drugs we already know are safe to use." What's the alternative? Put it on the market without ever testing it? At some point, it must be tested.
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