Martin & Jones has compiled news articles on Ketek, including information on reports of serious side effects and the recent FDA warning. We hope you will find the information we have provided to be helpful. This page is updated frequently, so we encourage you to visit us often for up-to-date news on Ketek and our law firm's involvement in Ketek lawsuits.
If you or a loved one has been harmed by Ketek and you would like to be contacted to discuss your legal rights, please contact us.
In an internal review, a federal drug safety official concluded that a controversial antibiotic made by a French drug company should be withdrawn, according to e-mail messages exchanged among top agency officials.
The official, Dr. David Graham, part of the Food and Drug Administration's (FDA) drug safety office, wrote in a message dated June 16 that the agency's approval of Ketek, an antibiotic made by Sanofi-Aventis that is also known as telithromycin, was mistake.
Federal drug regulators issued a strong warning Thursday that Ketek, a controversial antibiotic, could in rare circumstances cause serious liver injury, liver failure and even death.
''We clearly now understand that there is risk of serious liver injury with Ketek,'' said Dr. John Jenkins, director of the Food and Drug Administration's Office of New Drugs.
The label of a novel antibiotic will be updated to reflect reports of severe liver problems, including several deaths, associated with its use, the drug's maker and health officials said Thursday.
Sanofi-Aventis' Ketek will carry a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in patients treated with the drug. The company also is providing additional information to patients and doctors.
New Safety Information to be Added to Product Labeling
FDA News | June 29, 2006
The Food and Drug Administration (FDA) today completed its safety assessment of Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks. Ketek is the first FDA-approved antibiotic of the ketolide class. It 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.
The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. The manufacturer is revising the drug labeling to address this safety concern.
Los Angeles Times | June 17, 2006
Four deaths from liver failure linked to a new antibiotic have renewed concerns about the nation's drug safety program, leading some experts to question the effectiveness of internal fixes made at the Food and Drug Administration since the withdrawal of the discredited painkiller Vioxx.
"This is another example that we should see as a signal that the current system needs reform," said Arthur A. Levin, director of the New York-based advocacy group Center for Medical Consumers and a member of the FDA's drug safety advisory committee.