Ketek
Side Effects
Since its approval by the Food and Drug Administration (FDA) in 2004, Ketek, the first antibiotic of the ketolide class, has been under constant scrutiny from the FDA's Division of Drug Risk Evaluation. The FDA rejected the French-manufactured drug in 2001 and again in 2003 because of the insufficient warnings on the label.
Within two years the drug has been prescribed to 3.35 million people and has already caused 12 cases of liver failure, 23 cases of severe liver damage and four deaths . In May 2006, the FDA recommended a “ black box warning ” be added to the label of Ketek, warning of the increased risk for severe, potentially life-threatening liver damage. In another memo, the FDA stated that patients using Ketek suffered a “profound degree” of liver injury.
Common Ketek Side Effects
In addition to the increased risk of death and severe liver problems, the popular antibiotic is also associated with a laundry list of other serious Ketek side effects, including:
Heart palpitations and arrhythmias
Low blood pressure (hypotension)
Temporary loss of consciousness
Inflammation of the liver (hepatitis)
Individuals who have experienced these or other adverse Ketek side effects should consult with a physician immediately.
Ketek Side Effects and The Law
If the manufacturer of Ketek, Sanofi-Aventis, deliberately failed to reveal important information regarding the drug's safety, it may be held responsible for any injuries sustained as a result. Individuals who have been seriously injured by Ketek may be entitled to recover damages including:
Medical expenses
Pain and suffering
Lost wages
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Ketek
Current News
Health Canada Endorsed Important Safety Information on Ketek (telithromycin)
Sanofi-aventis Canada Inc. in consultation with Health Canada would like to inform health care professionals of important updated safety information regarding Ketek (telithromycin) tablets. Based on information in published case reports and post-market adverse event reports, the Canadian Product ...read more
FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling
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 ...read more
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