Monday, July 10, 2006

FDA gives continuing approval to Ketex-fatal liver disease notwithstanding

The FDA, after reviewing the fatal cases of liver disease associated with use of telithromycin( Ketex) decided to continue to allow its use. It is approved for mild to moderately severe respiratory infections including community acquired pneumonia,bacterial sinusitis and exacerbations of chronic obstructive lung disease.

It has been promoted heavily by the manufacturer and uses as a promotional hook the purported theoretical arguments that it is less prone to induce bacterial resistance.It range of activity seems about the same as Biaxin and Zithromax and a side effect profile in the same general range as these two well established and safe drugs with the exception of the fatal liver disease complication

Earlier I had blogged about allegations of possible fraud ( fabrication of data) in some of the treatment trials involving Ketex, quoting Health Care Renewal and the Wall street Journal.
The drug was approved by the FDA in April 2004 and has been advertised heavily and promoted by "thought leaders" in various CME and pseudo-CME forums.Most recently, a RCT using Ketex in asthma patients showed some indications of improvement. In June 2006, Sanofi-Aventis suspended enrollment in pediatric studies that were using Ketex for respiratory infections. With the reported liver disease cases, I doubt we will see many doctors recommending telithromycin to "improve" asthma or to treat children.

Both the manufacturer and some ID specialists appropriately concerned about the antibiotic resistance issue had high hopes for Ketex. It seemed to offer good defenses against the mechanisms by which bacteria were developing resistance to the macrolides. But I can see no indication for a drug that in the individual patient offers nothing that a macrolide does not offer and runs the risk of serious liver toxicity.There are too many other good antibiotics to use in respiratory tract infections to risk fatal liver disease.

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