Sanofi-Aventis said it is standing by the safety profile of its antibiotic Ketek (telithromycin) despite findings by doctors that three patients suffered severe liver damage after taking the drug.
“With what we know now, we’ve concluded that these events do not alter the drug’s safety profile,” a Sanofi-Aventis spokesman told Reuters, adding that the side effects were infrequent and were mentioned in the prescribing information.
US health officials urged doctors on Friday to watch patients taking Ketek for signs of liver problems and to stop treatment if symptoms developed. Physicians reported that three patients in North Carolina had developed severe liver damage and one of them died after being treated with Ketek.
Ketek is sold in Europe, Japan and the US where the FDA approved it in 2004 to treat acute bacterial bronchitis and pneumonia.
Sanofi-Aventis is in reportedly in discussions with all health authorities where Ketek is sold and said it would consider all safety measures and implement them if needed.