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Enrollment of children in drug study suspended

Reports link controversial antibiotic to liver failure in adults

Jun 9, 2006 | AP

French pharmaceutical company Sanofi-Aventis SA said Thursday it has suspended enrollment in studies of its antibiotic Ketek in children, amid reports the drug can cause liver failure in adults. The company denied the studies were halted because of safety concerns and said it was only trying to ensure the trials’ design complied with FDA requirements.

The Paris-based company said the Food and Drug Administration did not request the action. It also said the suspension was not linked to a published report which said an FDA official last month requested the trials be halted because Ketek could be deadly.

According to a government Web site, Sanofi-Aventis is conducting four different studies of Ketek in 3,920 youngsters. The first started last June.

The drug is approved only for adults to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.

Sanofi spokeswoman Lisa Kennedy couldn’t immediately say how many children had been enrolled or when enrollment might resume.

Safety issues arose about Ketek in January after researchers reported three cases of severe liver problems, including one death. Ketek’s market share and prescriptions have plummeted since then.

In the 22 weeks ended June 2, Ketek’s share of the antibiotic market fell by more than half to 0.6 percent while the number of prescriptions plunged 69 percent to 24,476. Prescriptions vary on a weekly basis but the data provided by pharmaceutical tracking firm Verispan LLC show the drug’s use has been declining steadily.

Approved in 2004, Ketek captured only a small part of the antibiotics market because physicians often shy away from new products until they establish a track record, especially when there are other drugs available, doctors said.

Dr. Jilan Shah, associate program director of infectious diseases at Cabrini Medical Center in Brooklyn, N.Y., said he had expected Ketek’s sales to increase in the future as patients become increasingly resistant to other antibiotics. But he said he has changed his mind because of the level of liver toxicity associated with the drug.

Four deaths

On Thursday, The New York Times cited internal FDA memos which said that some safety officials wrote the agency should consider forcing Sanofi-Aventis to remove Ketek from the market, severely restrict its use, or add a prominent waning label about its potentially fatal side effects.

The report also said that by April, the FDA had reports of 110 cases of liver problems associated with Ketek, and that the rate of acute liver failure connected to the drug was about four times the rate of such events seen in other antibiotics.

Before Sanofi-Aventis’ announcement, Sen. Chuck Grassley, R-Iowa, asked the FDA to explain what it was doing to inform parents about the safety concerns surrounding pediatric trials of Ketek. Grassley has been investigating the FDA actions regarding the approval and post-market surveillance of Ketek.

Last month, there were reports of an internal FDA memo that said the drug should bear stricter warnings about its effect on the liver. The memo said the FDA had received reports of 12 cases of acute liver failure, including four deaths, in patients treated with Ketek.

FDA spokeswoman Susan Bro said the agency was not considering removing Ketek from the market but that it was conducting a review of the drug’s safety. She said the review would be completed shortly.

Doctors are not waiting for any FDA decision. Dr. Len Horovitz, an attending physician in the pulmonary division of Lenox Hill Hospital, has stopped prescribing Ketek even though his patients haven’t suffered any adverse reactions.

“There are other drugs you can use so why use it?” Horovitz asked. “It looks like something is up with the drug.”


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