Ketek Testing for Children Halted
August 21, 2006 16:20

One day following a report in the New York Times, Sanifo-Aventis, manufacturer of Ketek, suspended its clinical trials of Ketek on children with ear infections. The FDA has not announced any action.

The New York Times reported that there was debate among FDA physicians as to whether or not Ketek was safe enough for the public but the FDA released Ketek anyway and only did a minor label change. What is so troubling is despite the toxic warnings; Ketek was being tested on almost 4,000 infants and children in more than a dozen countries including the United States.

The FDA didn't comment nor did it take any action. (AHRP)

Approval of Ketek a Mistake Claims FDA
August 27, 2006 16:20

According to internal emails among FDA scientists and researchers, the antibiotic Ketek should not have been approved for the pharmaceutical marketplace. The Ketek emails further stated that there was no real proof if the drug actually worked, if it worked... (Read Article)