WASHINGTON — Four deaths from liver failure linked to a new antibiotic have renewed concerns about the nation's drug safety program, leading some experts to question the effectiveness of internal fixes made at the Food and Drug Administration since the withdrawal of the discredited painkiller Vioxx.
"This is another example that we should see as a signal that the current system needs reform," said Arthur A. Levin, director of the New York-based advocacy group Center for Medical Consumers and a member of the FDA's drug safety advisory committee.
"It's not about the FDA not 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," he said.
Marketed as Ketek, the antibiotic linked to the liver deaths was approved in 2004 as a treatment for serious respiratory infections that have become increasingly resistant to older drugs. At the time, government regulators recognized the potential for liver damage but concluded that the risk was about the same as for other antibacterial drugs.
After Vioxx was linked to higher rates of heart attacks and strokes and was removed from sale in 2004, the FDA set up an in-house drug safety board and pledged to improve communication about emerging problems.
Critics say the agency needs a stronger, more independent safety office; more funding; better databases; and new legal powers to compel manufacturers to track adverse drug reactions.
Doctors in North Carolina were the first to raise concerns about Ketek. They submitted an article to a medical journal, Annals of Internal Medicine, reporting three cases of acute liver failure in previously healthy patients who had taken the drug.
In January, the journal put an "early release" version of their findings on its website and followed up with a fuller article in the print edition two months later.
Drug reactions account for more than half of all cases of liver failure, a medical catastrophe that is otherwise extremely rare -- and in these cases, the doctors discovered, Ketek was the common denominator.
A May 16 internal memo by FDA safety investigators suggested that the problems with Ketek could be more serious than those identified in the journal article.
In the memo, a copy of which was reviewed by The Times, investigators described 12 cases of liver failure among Ketek patients. Four patients died, and one required a liver transplant. One patient had taken a single dose of the drug before becoming ill.
