The new antibiotic Ketek has already had four liver-related deaths connected with it, leading to some questions as to the internal processes of the Food and Drug Administration. Arthur A. Levin, director of the New York based Center for Medical Consumers and member of the drug safety advisory committee at the FDA has called the Ketek/liver failure connection “another example that we should see as a signal that the current system needs reform.” He added, “It’s not about the FDA doing its job — it’s that the process we have in place, and the authority the FDA has at present, simply aren’t up to the task.”
The antibiotic Ketek was approved in 2004 for the treatment of serious respiratory inflammations which are now more resistant to older drugs. Government regulators then recognized the danger and potential to damage the liver, but decided the risk was equal to the risk in other respiratory inflammation antibiotic drugs. Then, in North Carolina, questions were raised concerning Ketek as three cases of acute liver failure were reported by Ketek users. The FDA then identified the drug as dangerous in a May 16 memo, stating 12 reported cases of kidney problems including four deaths and one requiring a kidney transplant. It was found that Ketek users did have more liver problems than those who took other medications.
Since the FDA’s initial approval, over 5 million prescriptions for Ketek were written. Now the drug has been suggested for the highest possible warning the FDA has to offer, which more than likely will lead to strong discretion when issuing the drug in the future. Concerns with the FDA’s internal maintenance of such issues circle around preventing the release of “safe” drugs in the future. While the Food and Drug Administration did install an in-house drug safety board pledged to improve the coordination of emerging problems with drugs, the further release of such drugs as Ketek is clear evidence for many critics that the FDA needs even stricter policies, a more independent and well organized safety office, better funding and databases, and legal powers urging manufacturers to track faulty drug issues.
