In June 2006, the FDA issued a strong warning that the widely prescribed antibiotic Ketek (telithromycin), manufactured by Sanofi-Aventis Group, had proven to be a direct link to such side effects as liver toxicity, liver failure and death in some patients.
Opposition from within the FDA
In July 2006, an internal memo written by Dr. David Graham of the FDA’s Office of Drug Safety was leaked to the press. The memo opposed the use and prescription of Ketek.
Dr. Graham suggested the immediate withdrawal of Ketek from the world drug market. Citing his scientific studies, he said he was “unaware of any unique or life-saving advantage offered by telithromycin [Ketek] that might offset or balance against either an absence of safety data or evidence of unusually high hepatoxicity [liver toxicity].”
The FDA has warned that Ketek has such side effects as liver toxicity, liver failure and death.
Graham also stated that the Office of Drug Safety does not even fully know if the drug works. As an FDA scientist, he reported that he was “flying blind as far as safety goes,” and that this was not “an issue that can or should be dealt with by labeling.”
In the U.S. alone, 14 adult patients have experienced liver failure, four of whom died. Twenty-three other patients have reported serious liver injury.
Dr. Graham suggested that the reports of after-market reporting were very poor, rating from “non-existent” to “1 in 4,600.”
If you have experienced liver injury due to the prescription drug Ketek, please call the law office of Sam Levine, toll-free at (888) 404-LAWYER or fill out our online contact form.
