Ketek Liver Injury and Lawsuit Information

What is telithromycin?

Telithromycin is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Sanofi-Aventis under the brand name Ketek. Telithromycin was approved in the U.S., in April 2004.

Telithromycin is indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. FDA approved a labeling supplement submitted by Sanofi-Aventis as a “Changes Being Effected” (CBE) supplement, which highlights the WARNINGS section of the labeling to raise attention to the risk of liver toxicity associated with Ketek and strengthen the WARNINGS for patients with myasthenia gravis.

A CBE is a mechanism available under FDA regulations to allow a company and FDA to promptly address an important safety issue. This process allows a firm and FDA to expedite the review, approval process, and distribution for revised prescribing information when safety issues arise. A labeling supplement can be submitted to the FDA as a CBE to add or strengthen a contraindication, warning, precaution.

FDA determined that these updates to the labeling were necessary based on the agency’s safety review and assessment of the drug. When new, unanticipated risks are detected after approval, an FDA review team (consisting of medical doctors, statisticians, safety evaluators, epidemiologists, and other experts) carefully evaluates the information provided by the sponsor and/or the information gathered from the postmarketing surveillance program.

As part of its review the FDA must assess the severity and frequency of the adverse event and reach a determination regarding the benefit/risk profile of the drug. No drug is absolutely safe. All drugs have side effects. When FDA determines that a drug is safe and effective "Safe" means that the benefits of the drug appear to outweigh the risks when used as directed in the FDA approved labeling.

FDA will continue to monitor reports of adverse events with Ketek and will take appropriate additional regulatory actions if new information leads to a different conclusion about Ketek’s benefit/risk profile.

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