Novel Antibiotic To Have Severe Liver Failure Warning

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Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Pharma Industry / Biotech Industry
Article Date: 30 Jun 2006 - 13:00 PDT


Ketek (telithromycin) was approved by the FDA in 1994 for respiratory tract infections, sinusitis, community-acquired infections and bronchitis. There have been reports, since its approval, of patients who took the drug having severe liver problems - several died. The drug will now have a warning of liver failure and severe injury.

Sanofi-Aventis, the makers of Ketek, are also providing patients and doctors with information.

The new label warns to look out for signs of hepatitis - malaise, fatigue, jaundice, anorexia and nausea. Patients are told to stop taking Ketek immediately and see their doctor if they have signs or symptoms of hepatitis. The warning also contains revised recommendations for the use of Ketek in patients with myasthenia gravis.

Sanofi-Aventis, as well as the FDA, believe Ketek's benefits are still greater than its risks.

During the month of April, 2006, 12 cases of acute liver failure were reported to the FDA, of which four died, one had to have a liver transplant. All the patients had been treated with Ketek. Experts believe Ketek was the link as no other association could be found. Two more cases have been reported since April.

Even though the number of deaths and liver failure are proportionally higher than would be expected with other antibiotics, experts say it is not yet possible to conclude that the risk of serious complications is higher for Ketek. This is because the cases of liver failure associated with Zetek stimulated other reports.

Zetek is a useful drug for patients who are infected with bacteria that have become resistant to other antibiotics, says Dr. Bruce Lavin, VP, Internal Medicine, Sanofi-Aventis.

The Senate Finance Committee is investigating fraud allegations related to the Ketek trials.

Sanofi-Aventis has halted the enrolment of children in Zetek trials.

About Ketek (telithromycin) tablets

Ketek is one of a new class of antibiotics called 'ketolides'. It was designed specifically to treat community-acquire respiratory tract infections. It is also indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and mild to moderate CAP communityacquired pneumonia, including those infections caused by multi-drug resistant S. pneumoniae, in patients 18 and older.

Ketek unlike other antibiotics, binds strongly to two sites on the bacterial ribosome, stopping protein production and eradicating the targeted bacteria. This strong dual binding helps provide in vitro coverage against antibiotic-resistant strains of S. pneumoniae. Its spectrum of activity provides tailored coverage of common respiratory pathogens.

Written by: Christian Nordqvist
Editor: Medical News Today


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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