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On January 20, 2006, the FDA advised the public that of reports of patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases had also been reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan.
On June 29, 2006, the Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin). FDA determined that additional warnings about the risk of liver toxicity are required and the manufacturer has revised the drug labeling to address this safety concern. In addition, the WARNINGS for patients with myasthenia gravis are being strengthened.
The drug Ketek is used to treat acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. Due to reports of Ketek liver injuries, including rare cases of serious live failure, four reported deaths and one liver transplant after the administration of the drug. The FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems. Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function.
If you have taken Ketek and suffer from signs or symptoms of liver problems, fill out the form below to have your potential Ketek claim reviewed by an attorney.
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