Usage:

Ketek, known generically as telithromycin, is an antibiotic used for the treatment of respiratory infections including chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek is manufactured by the French pharmaceutical giant Sanofi-Aventis.

Telithromycin is administered as tablets. Two 400mg tablets to be taken together, daily, with or without food. It prevents bacteria growth, by interfering with its protein synthesis.

Side Effects:

Most common side-effects are gastrointestinal; diarrhea, nausea, abdominal pain and vomiting. Headache and disturbances in taste also occur. Less common side-effects include palpitations, blurred vision and rashes. It has also been found to exacerbate Myasthenia Gravis, an autoimmune disorder that causes progressive muscle weakening.

Following use of the Ketek, liver failure has been reported at a significantly higher rate than what has been associated with other similar antibiotics. Three cases of liver toxicity were reported to FDA MedWatch and reported in an article in the Annals of Internal Medicine. Of these cases, one patient recovered, one patient needed a liver transplant and the other died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek and were not using other prescription drugs. The two latter patients had reported some alcohol use.

Litigation:

A Congressional investigation is attempting to determine why the drug was approved even after a physician was convicted of fraud in clinical trials of Ketek. The initial new drug application for telithromycin was rejected by the FDA in June, 2001, citing a request for additional safety data regarding liver injuries, blurred vision, and other possible side effects. Based on these concerns, the FDA ordered Sanofi to conduct further safety tests.

The FDA uncovered some problems with Sanofi's Study 3014 with have resulted in the imprisonment of the lead subject ruecruiting physician, who recruited 414 subjects, at $400 each according to the contract introduced in evidence at her trial. She is now in federal prison after pleading guilty to fraud resulting from the fabrication of data.

Internal corporate documents reviewed by The Wall Street Journal indicate the company's concern with its highest recruiter, but the concerns were not disclosed to the The second-high enroller (251 patients) was found during an FDA audit to have not followed the protocol or reported adverse drug reactions. The third-highest recruiter (214 patients) was, at the time, working with a probationary license under sanction of a state disciplinary board; the FDA audit found evidence of records altered with "white-out."

What is perhaps most outrageous about the entire sad affair is that Study 3014 was specifically mandated to investigate liver toxicity. Now, after being on the market for two years, there is new evidence that Ketek is harmful to the liver. A recent analysis of the FDA's post-marketing database showed that the rate of reporting of acute liver failure was 3.5 to 11 times as high for Ketek as for other antibiotics, with a reporting rate of 167 cases of acute liver failure per 1 million person years of telithromycin use, as compared with the expected rate of 1 case per 1 million person-years.

If you or a loved one developed liver failure or any other side effects as a result of using Ketek, please fill out the short form to the right for a free and confidential consultation about your potential case.