Antibiotic May Cause Serious Liver Damage

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Antibiotic May Cause Serious Liver Damage

New Label to Warn of Potential Health Danger

By ANDREW BRIDGES

AP

WASHINGTON (June 29) - The label of a novel antibiotic will be updated to

reflect reports of severe liver problems, including several deaths,

associated with its use, the drug's maker and health officials said

Thursday.

Sanofi-Aventis' Ketek will carry a bold-type warning about the rare

reports of liver failure and severe injury, some of them fatal, in

patients treated with the drug. The company also is providing additional

information to patients and doctors.

The Food and Drug Administration approved Ketek in 2004. The drug is used

to treat respiratory tract infections, bronchitis, sinusitis and

community-acquired pneumonia. Both the FDA and Sanofi-Aventis believe the

drug's benefits still outweigh its risks.

Through April, the FDA has received reports of 12 cases of acute liver

failure, including four deaths, among people treated with Ketek. A fifth

required a liver transplant.

" In certain of hese cases, it appears there are no other likely causes of

liver injury, so it does appear they were linked to the use of the drug, "

said Dr. , director of the Office of New Drugs in the FDA's

Center for Drug Evaluation and Research.

The FDA will continue to monitor the safety of Ketek and take further

action if necessary, said a second agency official, Dr. Gerald Dal Pan of

the Office of Epidemiology and Surveillance in the drug center.

There have been two further cases of acute liver failure reported since

April, though details were not immediately available, Dal Pan said.

The FDA also knows of 23 other cases where patients had serious liver

injuries after receiving the antibiotic, which also is called

telithromycin.

The rate of reported liver problems associated with the drug is 23 per 10

million prescriptions filled, according to the FDA. In a previously

disclosed internal memo, the FDA said the rate appeared higher in

comparison with similar antibiotics.

But a study published in January that detailed several of the liver cases

associated with the drug may have stimulated the reporting of further

problems. That can skew perceptions of the risk of Ketek compared with

older but similar antibiotics.

" At this point we cannot conclude the risk is higher than with other

antibiotics used to treat these conditions, " Dected with trials of Ketek,

as well as how the FDA has handled safety issues associated with the drug.

" There are questions about whether this drug should stay on the market,

and there's great legitimacy to those questions. Ketek is another example

where the FDA accommodated a drug maker and turned a blind eye to serious

safety concerns, " Sen. Grassley, R-Iowa, the committee's chairman,

said in a statement.

The updated label for Ketek warns doctors and patients to watch for signs

of hepatitis such as fatigue, malaise, anorexia, jaundice and nausea.

Patients with signs or symptoms of hepatitis should stop treatment with

Ketek immediately and seek a medical evaluation, including liver functions

tests, according to the label.

The updated label for Ketek warns doctors and patients to watch for signs

of hepatitis such as fatigue, malaise, anorexia, jaundice and nausea.

Patients with signs or symptoms of hepatitis should stop treatment with

Ketek immediately and seek a medical evaluation, including liver functions

tests, according to the label.

The label was updated to warn of cases of death and life-threatening acute

respiratory failure seen in Ketek-treated patients with myasthenia gravis,

an autoimmune disorder marked by muscle weakness and fatigue. The FDA

knows of three such deaths. Patients with the disorder should not be given

Ketek unless other options aren't available, the company said.

This month, Sanofi-Aventis stopped enrolling children in trials of the

drug. The company said it had not identified any safety reason that would

merit the " pause, " but that it wanted to confirm the trial conformed with

FDA guidelines.

U.S. sales of Ketek were an estimated $50 million in the first half of

2006, the company said.

Copyriht 2006 The Associated Press. The information contained in the AP

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[Guest guest]

....maybe toxic liver due to death of microbes?

>

> Antibiotic May Cause Serious Liver Damage

> New Label to Warn of Potential Health Danger

> By ANDREW BRIDGES

> AP

> WASHINGTON (June 29) - The label of a novel antibiotic will be

updated to

> reflect reports of severe liver problems, including several deaths,

> associated with its use, the drug's maker and health officials said

> Thursday.