Sanofi-aventis said Thursday it has added a new bolded warning to the labeling of its antibiotic Ketek (telithromycin).
The company said that, after conferring with the Food and Drug Administration, the drug’s prescribing information has been changed to warn of a risk of liver damage and also advises physicians against using Ketek in patients with a condition known as myasthenia gravis.
“This update is based on a rigorous analysis of the available data, including consultation with leading experts to ensure that we had the most informed understanding possible with respect to hepatic and myasthenia gravis adverse events,” said Sol Rajfer, president of U.S. science and medical affairs at sanofi-aventis.
He added, “Based on the in-depth review of the clinical trial and post-marketing data, we continue to believe that the benefits of Ketek outweigh the risks when the drug is used as directed for its approved indications.”
Ketek is approved to treat acute bacterial exacerbation of chronic bronchitis (AECB), acute bacterial sinusitis (ABS), and mild to moderate community-acquired pneumonia (CAP) caused by susceptible pathogens.
The antibiotic is used to treat mild to moderate CAP caused by multi-drug resistant S. pneumoniae (MDRSP), Sanofi-aventis said.
The company noted it suspended enrollment in a Ketek pediatric trial earlier this month to confirm the trial design is consistent with FDA expectations, adding the enrollment was not halted for safety reasons.
Available in the United States since 2004, sales of Ketek in the first half of 2006 were about $50 million, the firm said.