FDA Warns Antibiotic Can Damage Liver

The Food and Drug Administration is warning doctors about Ketek, an antibiotic used to treat common respiratory infections. Four deaths from liver failure have been attributed to the drug.

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MADELEINE BRAND, host:

This is DAY TO DAY. I'm Madeleine Brand.

The Food and Drug Administration is warning that a popular antibiotic can cause acute liver failure and death. The drug is called Ketek. It's used to treat common respiratory infections. Prominent senators asking if Ketek should even be sold.

NPR's Snigdha Prakash reports.

SNIGDHA PRAKASH reporting:

Ketek is a young drug. It's been sold in the United States for just over two years. On its one-year anniversary in April 2005, the FDA gave it a clean bill of health, but not yesterday. The agency now says that as of April this year, it had identified 12 cases of acute liver failure and 23 cases of acute serious liver injury on Ketek. Some patients developed the problems after taking just a few doses of the drug, and their condition worsened quickly. Four patients died, and one received a liver transplant.

John Jenkins is the director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research.

Dr. JOHN JENKINS (Director, Office of New Drugs, FDA): We clearly now understand that there is a risk of serious liver injury with Ketek.

PRAKASH: The FDA says that if the reports continue to come in at the current rate, 23 cases of acute liver failure will be reported for every 10 million Ketek prescriptions that are written. The FDA has learned of two more cases of acute liver failure on Ketek since April, but it's still investigating those. Officials didn't say if either of those cases had also resulted in death. Only a small fraction of drug reactions, maybe as small as one percent, are reported to the FDA by doctors or patients.

Jenkins was asked if it made sense to use a drug with such serious side effects to treat garden-variety infections: bronchitis, sinus infections, and mild pneumonia? He said Ketek is no worse than other antibiotics.

Dr. JENKINS: You're looking at a playing field where all of the drugs that are available to treat these conditions have the potential to cause serious adverse events. And we're putting Ketek in prospective to those other drugs. So given what we know today, we believe that the benefits of Ketek outweigh the potential risk, when it's used according to the labeling that we approved today.

PRAKASH: The new label describes the liver problems, and also warns about a separate problem among patients with a neurological condition called myasthenia gravis. The action wasn't enough to satisfy Senator Charles Grassley. The Iowa Republican said, at the very least, Ketek should carry the strongest possible warning, the so-called Black Box. He also said there are legitimate questions about whether Ketek should even be on the market.

Senator CHARLES GRASSLEY (Republican, Iowa): Just this week, a family lost an 18-year-old kid, and they reported to us that it was because that kid was given Ketek.

PRAKASH: Grassley has been looking into the FDA's decision to approve the drug, even though a crucial safety study had serious fraud. The doctor, who tested the drug on the largest number of patients, admitted she didn't give the drug to all of them. This morning, Grassley promised he's not done with his investigation.

Sen. GRASSLEY: I'm not to the bottom of this pile yet. Before said and done, I think there's going to be an awful lot of people at FDA that have egg in their face. And the reason they're going to have egg in their face is because they're more worried about their public relations than the safety of the public and the efficacy of the drug.

PRAKASH: The FDA says it will continue to monitor reports of problems with Ketek, and will take further actions if they prove necessary.

Snigdha Prakash, NPR News, Washington.

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