February 12, 2007: FDA Warns on Ketek Use Risks
The antibiotic Ketek should no longer be used for the treatment of sinusitis and bronchitis, the U.S. Food and Drug Administration (FDA) is warning patients and health care providers. The new warnings came as part of an FDA announcement of changes to Ketek's label, including stonger warnings regarding the drug's side effects, and the addition of a "black box" warning stating that Ketek should not be used to treat patients who have myasthenia gravis, a condition that causes muscle weakness. The FDA continues to approve the use of Ketek in treatment of patients with pneumonia. Ketek is manufactured by Sanofi Aventis, and was originally approved by the FDA in 2004. Read the FDA Press Release

June 29, 2006: FDA Completes Safety Assessment of Ketek
The U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients that it has completed its safety assessment of Ketek, an antibiotic medicine used to treat certain respiratory infections caused by bacteria. Ketek has been associated with rare cases of serious livery injury and liver failure, including four reported deaths and one liver transplant after the administration of the drug. Although the FDA concluded that Ketek's benefits outweigh its risks, it has determined that additional warnings are required, and advises both patients and healthcare professionals to watch for signs and symptoms associated with liver injury. Click here to read more from the FDA.