Internal email messages within the FDA now reveal that the agency pushed the drug Ketek through approval channels knowing of its harmful effects. Four FDA safety officials sounded the alarm questioning Ketek's safety but were ignored. A key clinical trial for the drug, involving 24,000 patients, was repeatedly found to be fraudulent.Yet Ketek was approved anyway. More than five million prescriptions have been written for Ketek since its approval in the United States. Ketek can cause loss of consciousness, blurred vision, and in rare circumstances, even death. It has been linked to liver failure in 14 adults, four of whom have died; 23 more suffered serious liver injury.
In response, Aventis, the company that manufactures Ketek, announced it was adding a warning to the drug's label. Warning labels, however, don't make drugs any safer. They only provide a justification for the continued promotion of drugs that even some of the FDA's own scientists believe should be withdrawn from the marketplace. (FDA and Ketek - NewsTarget)
