Sanofi-aventis announced that the US prescribing information for its antibiotic Ketek (telithromycin) has been revised after discussion with the US Food and Drug Administration (FDA) to provide healthcare professionals and patients with updated information about adverse events reported in connection with the use of the product.
The revised prescribing information contains a bolded warning and additional information relating to the nature and characterization of hepatic events, as well as revised recommendations for the use of Ketek in patients with myasthenia gravis. These changes have been reviewed and agreed to by the FDA.
"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. 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," said Sol Rajfer MD, President of US Science and Medical Affairs at sanofi-aventis US.
Over the past 10 years infectious disease experts and medical societies throughout the world have expressed the need for new compounds active against antibiotic drug resistant S. pneumoniae. Ketek is effective and safe when used as directed for its approved indications in the treatment of acute bacterial exacerbation of chronic bronchitis (AECB), acute bacterial sinusitis (ABS), and mild to moderate community-acquired pneumonia (CAP) caused by susceptible pathogens. Ketek is indicated for the treatment of mild to moderate CAP caused by multi-drug resistant S. pneumoniae (MDRSP).
Earlier this month, sanofi-aventis voluntarily paused enrolment of its Ketek paediatric clinical trials. This pause is to allow the company to confirm that the current program remains consistent with the FDA's current thinking on the design of paediatric trials. It is important to note that no safety reason has been identified to warrant the pause in the enrolment of the paediatric clinical trials.
Ketek has been available in the US since 2004, where sales in the first half of 2006 are estimated to be 50 million dollars.